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AUTISM—WHY THE INCREASED RATES? A ONEYEAR UPDATE

HEARINGS

BEFORE THE

COMMITTEE ON

GOVERNMENT REFORM

HOUSE OF REPRESENTATIVES

ONE HUNDRED SEVENTH CONGRESS

FIRST SESSION

APRIL 25 AND 26, 2001

Serial No. 107–29

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

JOE SCARBOROUGH, Florida

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

——— ———

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

——— ———

——— ———

———

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 25, 2001 ................................................................................................... 1

April 26, 2001 ................................................................................................... 307

Statement of:

Bradstreet, James J., M.D. FAAFP; Cindy Kay Schneider, M.D. FACOG;

Jeff Segal, M.D.; and Sharon G. Humiston, M.D. ...................................... 38

McCormick, Marie, MDSCD, chair, Committee on Immunization Safety

Review, Institute of Medicine, accompanied by William Colglazier, executive officer, National Academy of Sciences; and Susanne Stoiber, executive officer .................................................................................................... 202

McDougle, Christopher J., M.D., Riley Children’s Hospital, Indiana University School of Medicine; Andrew Wakefield, M.D.; Walter Spitzer,

M.D., Faculty of Medicine, McGill University, Montreal, Canada; Boyd

E. Haley, Department of Chemistry, University of Kentucky; David

G. Amaral, MIND Institute, University of California, Davis; Dr. Elizabeth Miller, Public Health Laboratory, England; and Dr. Michael D.

Gershon, Department of Anatomy and Cell Biology, Columbia University .................................................................................................................. 89

Rennert, Owen M., M.D., Scientific Director, National Institute of Child

Health and Human Development, National Institutes of Health; Karen

Midthun, M.D., Director, Office of Vaccine Research and Review, Food

and Drug Administration, accompanied by Susan Ellenberg, M.D., Director, Office of Vital Statistics and Epidemiology; Norman Baylor,

M.D., Associate Director, Regulatory Policy, Office of Vaccines; and

Dr. Colleen Boyle, Acting Associate Director, Science and Public

Health, Center on Birth Defects and Developmental Disabilities, Centers for Disease Control and Prevention ..................................................... 314

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

of New Jersey; and Hon. Michael F. Doyle, a Representative in Congress from the Commonwealth of Pennsylvania ........................................ 25

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

Amaral, David G., MIND Institute, University of California, Davis, prepared statement of ........................................................................................ 160

Boyle, Dr. Colleen, Acting Associate Director, Science and Public Health,

Center on Birth Defects and Developmental Disabilities, Centers for

Disease Control and Prevention, prepared statement of ........................... 354

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

Letter dated April 24, 2001 ...................................................................... 4

Prepared statements of ............................................................................. 7, 310

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

Missouri, prepared statement of .................................................................. 22

Doyle, Hon. Michael F., a Representative in Congress from the Commonwealth of Pennsylvania, prepared statement of ......................................... 33

Gershon, Dr. Michael D., Department of Anatomy and Cell Biology, Columbia University, prepared statement of .................................................. 178

Gilman, Hon. Benjamin A., a Representative in Congress from the State

of New York, prepared statement of ........................................................... 378

Haley, Boyd E., Department of Chemistry, University of Kentucky, prepared statement of ........................................................................................ 137

Humiston, Sharon G., M.D., prepared statement of ...................................... 77

McCormick, Marie, MDSCD, chair, Committee on Immunization Safety

Review, Institute of Medicine, prepared statement of ............................... 205

Page

IV

Letters, statements, etc., submitted for the record by—Continued

Midthun, Karen, M.D., Director, Office of Vaccine Research and Review,

Food and Drug Administration, prepared statement of ............................ 336

Miller, Dr. Elizabeth, Public Health Laboratory, England, prepared statement of ........................................................................................................... 164

Rennert, Owen M., M.D., Scientific Director, National Institute of Child

Health and Human Development, National Institutes of Health, prepared statement of ........................................................................................ 318

Schneider, Cindy Kay, M.D. FACOG, prepared statement of ...................... 45

Segal, Jeff, M.D., prepared statement of ........................................................ 68

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

of New Jersey, prepared statement of ......................................................... 28

Wakefield, Andrew, M.D., prepared statement of .......................................... 96

Weldon, Hon. Dave, a Representative in Congress from the State of

Florida, prepared statement of Mr. and Mrs. Middlebrook, Indialantic,

FL ................................................................................................................... 219

(1)

AUTISM—WHY THE INCREASED RATES? A

ONE-YEAR UPDATE

WEDNESDAY, APRIL 25, 2001

HOUSE OF REPRESENTATIVES, COMMITTEE ON GOVERNMENT REFORM, Washington, DC.

The committee met, pursuant to notice, at 11:07 a.m., in room

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

of the committee) presiding.

Present: Representatives Burton, Morella, Ros-Lehtinen, Horn,

Davis, Weldon, Waxman, Maloney, Norton, Cummings, Kucinich,

Blagojevich, Tierney, Schakowsky, and Clay.

Staff present: David A. Kass, deputy counsel and parliamentarian; Mark Corallo, director of communications; John Callendar,

counsel; S. Elizabeth Clay, Nicole Petrosino, and John Rowe, professional staff members; Robert A. Briggs, chief clerk; Robin Butler,

office manager; Michael Canty and Toni Lightle, legislative assistants; Scott Fagan, staff assistant; Leneal Scott, computer systems

manager; John Sare, deputy chief clerk; Corinne Zaccagnini, systems administrator; Phil Barnett, minority chief counsel; Kate Anderson and Sarah Despres, minority counsels; Ellen Rayner, minority chief clerk; and Jean Gosa, minority assistant clerk.

Mr. BURTON. Good morning.

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 included in the

record. Without objection, so ordered.

I ask unanimous consent that all articles, exhibits, or extraneous

or tabular material referred to be included in the record. Without

objection, so ordered.

During the 106th Congress, I initiated oversight investigations to

look at the dramatic rise in autism rates and the many concerns

about vaccine safety. Autism rates have skyrocketed. Conservative

estimates suggest 1 in 500 children in the United States is autistic.

However, those rates are dramatically higher in some places such

as Brick Township, NJ, where the rates are 1 in 150. I think Congressman Smith, who is going to testify today, represents part of

that area.

In the first quarter of this year a child was diagnosed with autism every 3 hours in California. Last year, that rate was every 6

hours. Look at that graph. They are having an absolute epidemic

out there.

Indiana is seeing a similar trend in increased rates; 1 in 400 children in my home State is autistic. Between December 1999 and DeVerDate 11-MAY-2000 09:23 Feb 22, 2002 Jkt 000000 PO 00000 Frm 00005 Fmt 6633 Sfmt 6633 C:\DOCS\76856.TXT HGOVREF1 PsN: HGOVREF1
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cember 2000, requests for special education services for children

with autism went up 25 percent. That is a 25-percent increase in

requests for taxpayer-provided services in just a year.

We have a national and potentially worldwide epidemic on our

hands. It cannot simply be better reporting or an expanded definition of autism. There has to be more to it than that.

As with any epidemic, we need to focus significant energy and research on containing it. We need to locate the cause or causes. We

need to determine if this is the same condition we understand autism to be or not. Could this epidemic of children who regress into

‘‘autism’’ be another condition being called autism?

We need to be aggressive in developing and making available appropriate treatments for both the behavioral issues and the biomedical illnesses related to this condition. And we need to provide

credible and timely information to the public. Has the public health

sector responded adequately and appropriately to this epidemic?

We will be hearing from witnesses over the next 2 days to find out.

Autism, or Autism Spectrum Disorder, is devastating to families.

I know this from personal experience. My grandson, Christian, was

born healthy and developed normally. His story is not much different than that of the thousands of families we have heard from

over the last year. He met his developmental milestones. He was

talkative. He enjoyed being with people. He interacted socially.

Then Christian received his routine immunizations as recommended by the Centers for Disease Control and Prevention and

his life changed dramatically and very rapidly. We now know that

through his shots, he may have been exposed to 41 times the level

of mercury than is considered safe by Federal guidelines for a child

his size. This was on top of other mercury exposure from earlier

vaccinations.

Within 10 days of receiving his vaccines, Christian was locked

into the world of autism—within 10 days. Is it related to the MMR

vaccine? Is it related to the mercury toxicity? Is it the environment,

including food allergies? Or is autism purely genetic? Some would

have us believe that a child’s regression into autism within a short

time of vaccination is purely a coincidence. I ask those individuals

to show me the science that proves this theory.

On Monday, the ‘‘Measles-Mumps-Rubella Vaccine and Autism

Report’’ was released by the Institute of Medicine’s Committee on

Immunization Safety Review. We have Dr. Marie McCormick, the

Chair of this committee, here today to talk about the findings and

recommendations of the report.

I realize the headlines over the last 3 days have said that the

committee found no connection between the MMR vaccine and autism. I would urge all of you to read the entire report and recognize

that the committee found that there was insufficient evidence to

conclusively prove or disprove a connection between the MMR vaccine and acquired autism. And yet, on television all across this

country, every parent saw that there was no connection between

the MMR vaccine and autism.

Yet, that is not what the report said. I believe a disservice has

been given to the American people about this. Parents need to

know the risks involved with certain exposures their children have

to face. And they need to have all the facts, not part of the facts.

3

It should be noted that the committee notes in its conclusions

that it could not exclude the possibility that MMR vaccine could

contribute to Autism Spectrum Disorder.

In the scientific community, there is an accepted hierarchy of research methodology that builds a balanced foundation of the evidence. That is in attachment 1. What we learned from the Institute

of Medicine is that the research has not yet been conducted to

build this hierarchy of evidence regarding the question of whether

or not the MMR vaccine may be linked to the increased incidence

of autism.

We have substantial parental observation, which should never be

discounted. And we have several case studies and laboratory evidence showing measles virus in the guts of autistic children who

have bowel dysfunction. And we also have several population-level

epidemiological studies.

While the Immunization Committee noted that the epidemiologic

studies do not support an association at a population level, their

report stated that ‘‘it is important to recognize the inherent methodological limitations of such studies in establishing causality.’’ In essence, the studies that have been published and held up by

the public health community as ‘‘proof’’ against Dr. Wakefield’s hypothesis can never answer the question of whether or not MMR

vaccine is linked to autism in some children. We do not have

enough research to make an evidence-based final conclusion. What

we have is a clear indication that a problem exists for some children. We need to do the research to get our arms around that problem, so that we can prevent any further escalation of this epidemic

of acquired autism.

When the Institute of Medicine formed their committee, we were

assured that there would be no one on the committee who had ties

to the vaccine industry. We were told there would be nobody connected to the vaccine industry involved in the research done by this

committee. So I was disturbed to learn that the committee sent this

report out for review and comment prior to becoming final to numerous individuals who have ties to the vaccine industry, including

the manufacturer of the MMR vaccine.

They sent it out for critiquing, and there were changes made by

these other people outside. They also sent it to at least one individual who presented to the committee, but not to Dr. Wakefield and

the rest of the presenters. This preferential treatment is disturbing, and I would like to know why they did not send it to everybody

who was a presenter.

I am including in the record a letter I received from one of the

reviewers, and a previous witness to this committee regarding his

concerns about flaws in the evaluation of the published research.

He is with the University of Oklahoma, the Health Center. And

that will be included in the record.

[The information referred to follows:]

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5

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Mr. BURTON. I want to read just one part of his letter. ‘‘The report highly criticizes the peer review publications that

cite a causal association of the MMR vaccine and autism and does

not provide a similar critique of the peer review publications that

cite a lack of association of the MMR vaccine and autism.’’ It also says, ‘‘One of the publications that are used to support the

lack of the MMR vaccine and autism cites support of Merck and

Company in the acknowledgements.’’ They are the producer of the

MMR vaccine.

This is not mentioned in the Institute’s report and could be considered potentially as a pre-existing bias. We want to ask the person who is going to be testifying about the report why that happened.

They also sent it to at least one individual who presented to the

committee, but not Wakefield.

I am including in the record this letter I received from the reviewer about what he believes to be the flaws in the evaluation of

the published research. He also raises concerns about the lack of

the Institute’s acknowledgement in their evaluation that one of the

publications used to support a lack of a connection between the

MMR vaccine and autism was sponsored by Merck, the manufacturer of the MMR vaccine.

We have a very long hearing today. I am going to ask the witnesses to stick to the time limit so we can get through all the panels and have time for questions. We will be hearing first from my

colleagues and friends, the chairmen of the Autism Congressional

Caucus—which I am proud to be a member of—Congressman

Christopher Smith of New Jersey, and Congressman Mike Doyle of

Pennsylvania.

The record will remain open until May 11.

I apologize to Mr. Waxman for talking so long, but I feel very

strongly, as you know.

Mr. Waxman, you are recognized for an opening statement.

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

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14

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

The issue of autism has been getting increased attention in Congress over the last several years, and this attention is overdue. I

want to commend you, Mr. Burton, for your efforts to increase public awareness about autism through these hearings.

Autism is a particularly frustrating disease. We still do not understand what causes it and we still do not have a cure. All we

know for sure is that its impact on families can be devastating.

During the hearings held in this committee, we have heard parents tell tragic stories of children who appear to be developing normally and then all of a sudden retreat into themselves, stop communicating, and develop autistic behavior. Other parents have testified that their children never start to develop language skills, and

instead early on manifest symptoms of autism.

I can only imagine how frustrating and difficult this must be for

families. And I appreciate how urgently we need to understand

what causes autism, how to treat it, and if possible, how to prevent

it.

Fortunately, Congress is beginning to respond. Last year, I cosponsored a bill to increase NIH’s funding for autism research.

This funding was authorized as part of the Child Health Act, which

I also supported.

This year, Congress’ challenge will be to appropriate the funding

authorized by the Child Health Act. We will not make real progress

until we make sure NIH has the funding it needs to research this

debilitating disease.

At our first hearing last year, we heard moving statements from

the chairman and several witnesses that they had firsthand experience with observing signs of autism shortly after children received

the MMR vaccine. These witnesses voiced their suspicion that autism was caused by the vaccine.

I was deeply concerned about these remarks. Vaccines are unique

in medicine. Other medicines are administered to sick people to

make them better. But vaccines are given to healthy children and

they are mandatory in many States. When I heard the chairman’s

concerns, I was disturbed by the possibility that a vaccine that

States mandate could be making healthy children sick.

But at the same time, I was also worried for another very different reason. Vaccines are one of the greatest success stories in

modern medicine. Because of vaccines, children no longer suffer

brain damage or die from measles or are paralyzed by polio. I realize that publicizing fears that vaccines may cause autism could

cause some parents to stop vaccinating their children. And I worry

that this could be counterproductive. In the name of protecting our

children from autism, we could actually be subjecting them to

much greater risks of deadly or debilitating diseases such as measles, rubella, damage affecting developing fetuses or brain damage

from meningitis.

The theory that the MMR vaccine may contribute to autism had

been carefully reviewed by the British Medical Research Counsel,

which found no evidence to support it. However, what we needed,

I believe, was more study. That is why I proposed during last

year’s hearing that Chairman Burton join me in requesting that

the Secretary of Health and Human Services convene a panel of exVerDate 11-MAY-2000 09:23 Feb 22, 2002 Jkt 000000 PO 00000 Frm 00021 Fmt 6633 Sfmt 6633 C:\DOCS\76856.TXT HGOVREF1 PsN: HGOVREF1
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perts to examine the theory that the MMR vaccine could cause autism.

HHS responded to our request by contracting with the Institute

of Medicine, a branch of the National Academy of Sciences, to convene a panel of independent experts to review vaccine safety issues.

The Institute of Medicine identified potential experts and then subjected the experts to strict criteria that excluded anyone who had

financial ties to vaccine manufacturers or their parent companies,

previous service on the major vaccine advisory committees, and

prior expert testimony or publications on issues of vaccine safety.

The first issue this independent panel considered was the relationship between the MMR vaccine and autism. This panel of independent experts convened by the Institute of Medicine issued its

report on the MMR vaccine this Monday. The report is careful and

analyzes all the scientific information available and it concludes

that there is no credible scientific evidence establishing a link between the MMR vaccine and autism.

The Institute of Medicine report is consistent with the findings

of the British Medical Research Council. It is also consistent with

the conclusions of the World Health Organization, the American

Medical Association, and the American Academy of Pediatrics.

Taken together, the evidence clearly demonstrates that the MMR

vaccine is highly unlikely to be a cause of autism.

The next vaccine issue the Institute of Medicine will examine is

whether there have been adverse effects from thimerosal, a mercury-containing vaccine preservative. Because of concerns about

mercury in vaccines, FDA has acted to remove thimerosal from the

childhood immunization schedule. In fact, the entire vaccine schedule is currently available without thimerosal. From a public health

perspective, the remaining issue is whether FDA made the right

decision in choosing not to recall the thimerosal-containing vaccines that are still on doctor’s shelves.

FDA made the decision not to recall the vaccines because of concerns about a potential vaccine shortage. While there may be a theoretical risk to children from the thimerosal, FDA knew that there

is a very real risk to children if there is not enough vaccine available to protect them adequately from dangerous diseases such as

whooping cough or diphtheria. Moreover, FDA was also aware that

the Centers for Disease Control’s surveillance has not shown any

relationship between thimerosal and developing mental delays.

Based on these facts, FDA’s decision seems right, but I will welcome any further insight that the Institute of Medicine is able to

offer.

I sympathize with the parents who have testified at our hearings

and who will testify today. I want them to know that I am committed to doing everything Congress can to address the problem of autism. It is clear to me that we need to research aggressively the

causes and treatments of autism. Unfortunately, I believe the answers must come from science.

I thank the witnesses for appearing today and I look forward to

their testimony.

Mr. BURTON. I thank the gentleman from California.

Mr. Horn, do you have an opening statement?

Mr. Kucinich, do you have an opening statement?

19

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

this hearing. And thank you very much, Mr. Waxman, for making

it possible for me to be a member of this committee.

I have to say, in having the opportunity to sit through these committee hearings, I am taken with the concern for public health that

both of my esteemed colleagues have, Mr. Burton and Mr. Waxman. I cannot say that I have formed any conclusion about this because I think it is important to be open to new evidence.

I do think it would be significant and important at this moment

to read from the summary from the Immunization Safety Review

from the Institute of Medicine, which says, ‘‘The Immunization

Safety Review Committee concludes that the evidence favors rejection of a causal relationship at the population level between MMR

vaccine and ASD. However, this conclusion does not exclude the

possibility that MMR vaccine could contribute to ASD in a small

number of children because the epidemiological evidence lacks the

precision to assess rare occurrences of a response to MMR vaccine

leading to ASD and the proposed biological models linking MMR to

ASD, although far from established, are nevertheless not disproved.

Because of the limitations of the evidence, the significant public

concern surrounding the issue, the risk of disease outbreaks if immunization rates fall, and the serious of ASD, the committee recommends that continued attention be given to this issue. This committee has provided targeted research and communication recommendations. However, the committee does not recommend a policy review at this time of the licensure of MMR vaccine or of the

current schedule and recommendations regarding administration of

MMR vaccine.’’

It seems to me that this summary, which comes from the document that is under discussion, does have an inconclusive nature to

it in the overall issue, even if it does not recommend removal of

licensure of the vaccine. So in exploring the issue of this hearing,

why the increased rates, I think the persistence of our chairman

on the issue of autism and holding these hearings to update last

year’s work is well taken.

Often, hearings such as these raise more questions than they

give answers, and a determination for finding answers is an example that researchers need to follow. In order to find more answers,

I do not believe we should narrow the scope of the research. Rather, it is my hope that through the testimony of parents, Dr. Wakefield, and others we will be able to gain a broad view of the factors

that may cause autism.

A recent report released by the Immunization Safety Review

Committee at the Institute of Medicine is important in this regard

because, again, I want to state the conclusion of the committee that

the evidence favors rejection of a causal link between the MMR

vaccine and ASD is not the whole story. Media reports have

seemed to focus on the first part of the conclusion.

The second part of the conclusion, which is perhaps equally important, is that there is not enough evidence. The committee also

concludes that the epidemiological evidence is lacking in both

breadth and precision. That, by definition, means that we need to

do more research. It means we need to do more specific research.

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And while I would agree with Mr. Waxman that given the benefits of the vaccine, we do not want to be in a position where we

take the position for challenging health risks to a broad spectrum

of America’s children, I believe we also need to look at these increased incidents with a sense of mission to find out exactly what

is going on. The conclusion that the review made also notes that

biologic models that link the MMR vaccine and ASD are fragmentary. The committee identifies the limitations of the available

evidence, which can only mean that it is too soon to narrow our

scope of possible answers. Currently, there is $58 million in autism research funds at NIH.

Congress needs to focus on more funding for more research. I

would submit, instead of focusing just on the brain as the sole

search of autism research, we need to have a more holistic approach and review the entire body system. Indeed, there is some

evidence—admittedly, limited—that shows that vaccine may cause

a physical reaction in the digestive system that may cause autism.

Also, as I understand it, there is no conclusive research on

whether or not autism is caused by genetic factors or environmental factors. We may need to look at food allergies, vitamin deficiencies, and pollutants for their potential role in causing autism.

By looking at the entire human body and not just the brain as the

subject of research, we may find answers to questions that we, as

Members of Congress, the Autism Congressional Caucus, parents,

researchers, and others seek.

I look forward to the testimony of the witnesses. I encourage

Federal agencies and Congress to acknowledge their testimony and

have a broad scope in working to uncover the cause of autism with

additional and improved research.

Again, I thank the Chair.

Mr. BURTON. Thank you, Mr. Kucinich.

Ms. Ros-Lehtinen.

Ms. ROS-LEHTINEN. Thank you so much, Mr. Chairman.

I merely wanted to congratulate you once again for your valiant

efforts in helping bring this potential connection to light. Perhaps

there is a connection between the onset of autism and the vaccinations, perhaps not. But I know it is an important issue for this

committee and it is something that should be taken seriously.

I congratulate you for sticking to your commitment on this, in

spite of the overwhelming pressure you must be under from the

mainstream scientific community to let it go. I know in my community we have many cases of autistic children, children being

tracked by the school system in a different manner. Maybe we are

just getting better with diagnosis, but it just seems alarming to me,

in my area of south Florida, the high number of children with autism.

I think it is an important issue for our committee. I think you

have been a valiant leader in this fight. We do need to improve the

scientific evidence. We need to fund the research. We need to educate doctors in a better way because many times those symptoms

are going by unnoticed and the pediatricians just shrug their shoulders and say, don’t worry, this is just a phase that child is going

through. So we need to improve funding and we need to improve

the education for the medical community as well.

21

I want to thank you, Mr. Chairman, for being brave enough to

stick to your agenda and to keep our committee seriously looking

at the connection between vaccination and autism and just raise

the awareness on the issue of autism itself. And I congratulate our

colleagues, Mr. Smith and Mr. Doyle, for forming this coalition, of

which I am proud to be a member and with which I am proud to

be associated.

Thank you, Mr. Chairman.

Mr. BURTON. Thank you, Ms. Ros-Lehtinen.

Mr. Clay.

Mr. CLAY. Thank you, Mr. Chairman.

I welcome the opportunity to meet with the committee today. I

also welcome the opportunity to meet with my fellow Members of

Congress who are co-chairs of the Autism Caucus, Representative

Christopher Smith and Representative Michael Doyle. I especially

welcome the parents of autistic children who are witnesses. It is

noted that all of the parents on the panel are doctors. Additionally,

I welcome all other witnesses of panels three and four.

Mr. Chairman, my No. 1 focus while I am in office is children.

I am a father, as are you, and I am especially grateful that you extend that parental concern through this committee. Autism is a developmental disorder that appears within the first 3 years of a

child’s life. The exact causes are unknown. Many scientists who

study autism find that it occurs during fetal development, while

some speculate that there may be a form or forms of autism that

occur in the early years of a child’s life.

Some parents and researchers subscribe to the theory that this

form of autism may be caused by vaccinations. Presently, no confirmed scientific basis links vaccinations with autism and some of

the studies that support some of these theories have been discredited.

These are questions to which we must have answers. I have a

4-month-old son and a 7-year-old daughter. To you parents who are

witnesses today, your children could just as well have been my children. This is an area that must be given all the resources and attention necessary to find causes, effects, and solutions.

At this point, Mr. Chairman, I would yield back the balance of

my time and ask unanimous consent to enter my statement into

the record.

Mr. BURTON. Without objection, your prepared statement will appear in the record.

[The prepared statement of Hon. Wm. Lacy Clay follows:]

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Mr. BURTON. Dr. Weldon.

Mr. WELDON. I just wanted to mention my good friend from Ohio,

Mr. Kucinich, said earlier that NIH funding for autism research is

at $58 million. I believe that actual figure is substantially below

that, more in the range of $15 million. I think there is going to be

another hearing to get at that issue, but I just wanted the record

to reflect that.

Indeed, that is a big part of our problem. We are not funding

enough research in this arena. I thank you for calling this hearing,

Mr. Chairman.

Mr. BURTON. Thank you, Dr. Weldon.

Mr. Cummings.

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

for holding this hearing today.

During the 106th Congress, the Government Reform Committee

held numerous hearings on vaccine safety and the theories on the

correlations between vaccinations and autism. Earlier this week,

the Institute of Medicine Committee on Immunization Safety Review released a study that reported ‘‘there is little evidence of a

causal link between vaccinations and autism.’’ I agree with Dr. Steven Goodman of the Johns Hopkins University of Medicine—which so happens to be located in my district— who was a member of the IOM panel, when he said that ‘‘the risk

of not immunizing is much greater than any risk from immunizing.’’

Vaccinations provide important health protections so that our

children will not be at risk for a variety of illnesses and diseases.

Without vaccinations, the diseases we are now protected from will

return.

I applaud the CDC, the National Institute of Child Health and

Human Development, the National Institutes of Health, the Food

and Drug Administration, as well as the Kennedy Krieger Institute

and the Center for Development and Behavior Learning at the University of Maryland School of Medicine in Baltimore for their continued research in this area.

The causes of autism are unknown. There are some effective

treatments for some children, but there is no cure. My heart goes

out to parents, grandparents—like you, Mr. Chairman—and families of autistic children. I am convinced that with further research

a cause and cure will be found.

I am also concerned that there have been approximately 2,800

cases of autism reported in my home State of Maryland. I am also

concerned about the rise in the number of autism cases in California, New Jersey, and other States.

As such, I strongly believe that all theories for the cause of autism must be objectively and thoroughly researched. I echo the sentiments of the ranking member of this committee when he expressed last year in the Los Angeles Times that autism must not

alarm the American people and steer them away from vaccinating

their children.

I welcome the witnesses here today. I look forward to the testimony.

Thank you very much.

Mr. BURTON. Thank you, Mr. Cummings.

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Ms. Davis, do you have a comment?

Ms. Schakowsky.

Mr. BURTON. If not, Congressmen Smith and Doyle, would you

come forward, please?

We will start with you, Mr. Smith. We normally swear in our

witnesses, but I do not think we need to do it with you, too.

Mr. Smith.

STATEMENTS OF HON. CHRISTOPHER H. SMITH, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF NEW JERSEY; AND HON. MICHAEL F. DOYLE, A REPRESENTATIVE IN

CONGRESS FROM THE COMMONWEALTH OF PENNSYLVANIA

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

I thank you and the members of the committee for allowing my

good friend and colleague, Mike Doyle, and I to be here on behalf

of our Coalition for Autism Research and Education [CARE]. It is

currently made up of 115 Members of Congress. It is bipartisan. It

was formed recently and we have our first major briefing on Friday. The reason for the Coalition is to try to sensitize Members to

the need for more research dollars, more focus on this very, very

debilitating and heartbreaking tragedy that has been experienced

by increasing numbers of Americans.

I think most of you know that autism is a developmental disorder that has robbed at least 400,000 children of their ability to

communicate and interact with their families and loved ones. The

disorder, at least the common, prevalent number used, is found in

1 of every 500 people in America, although that number may have

to be ratcheted upwards, given some of the more recent evidence

that is coming forward.

My interest in autism has been a 21-year interest. I first got involved when the Eden Institute and Dr. Holmes in Princeton, NJ

brought me to one of their group homes and showed me the kind

of work they were doing. I worked with him and others throughout

the years to try to do what we could.

But, frankly, I have been amazed at what has not been done at

the Government level through the 1980’s and into the 1990’s on

this affliction, this disorder.

What brought me into it even more so in recent years—in one

of my largest towns, Brick Township, I became aware through

Bobby and Billy Gallagher, a very devoted husband and wife who

have two children with autism. They did their own study, if you

will, in Brick Township and found that there was an exorbitant

number of cases of children with autism. They became alarmed and

brought this information to me. They had the documentation and

we spent the better part of 3 hours reviwing it. In subsequent

meetings, it went on and on as we renewed it further.

We finally brought the CDC and other Government agencies into

Brick. Frankly, I was amazed, shocked, dismayed, and saddened by

how little the CDC and some of our great Government organizations knew about autism. It was as if the studies were passive, the

information collected was little to nonexistent—and that includes

in my own State. This began an effort to try to do more, to try to

at least get a handle on the prevalence of autism.

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What is happening? Is 1 in 500 real? Is it imaginary? Is it fiction? And as you pointed out, Mr. Chairman, what is the causation? Looking at your witnesses and knowing of your own deep,

personal commitment, I want to congratulate you at your dogged

determination to get at the reason. Why do we have this terrible

disorder seemingly cropping up in larger numbers in our communities, as we saw in my own Brick Township, NJ? What was

found—and this was very disconcerting—after a professional study

by CDC, was that rather than 1 in 500, the number was 4 per

1,000 in Brick. What are the reasons? Nobody really has any answers. The questions and the answers we have gotten in terms of

numbers only bring about more questions about why the prevalence? Why does there seem to be a cluster or why do we have a

higher number throughout the country?

Our own Department of Education in New Jersey has seen more

cases. Maybe this is just better reporting or maybe we have a problem that is an epidemic that has gone largely unnoticed. In 1991

there were 241 cases. That has grown to an incredible 2,354 cases

in 1999, an 876 percent increase. In just 4 years, the number of

autistic children aged 6 through 21 has more than doubled. So we

have a problem that really begs a significant increase in funding,

commitment, and prioritization within our Government.

Last year many of us argued successfully that the amount of

money going to the CDC and NIH be increased. We are doing it

again this year, making a similar request to the appropriators that

more money for prevalence and other studies be forthcoming.

Finally, Mr. Chairman, last year we did get a breakthrough with

the Centers of Excellence in Autism Epidemiology that was contained in Public Law 106–310. I had introduced legislation that

had that in it. We worked with a number of organizations and individuals. Mike Bilirakis, our good friend who chairs the committee,

put it as title one of his child health initiative bill. Now that is

awaiting full implementation so we can get a better handle on autism with these new centers of excellence looking at prevalence and

other issues associated with it.

Again, I want to thank you for your leadership. Let me offer one

note of caution. I know the IOM study suggests that there is not

a link. And I know that one of their witnesses will be here today

to amplify that. But I chair the Veterans Affairs Committee. I remember when the very first amendment I offered dealt with the

Agent Orange issue. Tom Daschle, now the minority leader over on

the Senate side, and I offered an amendment to try to provide service-connection disability and enhanced medical care for our veterans who had been exposed to dioxin, the contaminant contained in

Agent Orange.

For years, what we thought was credible evidence was laid aside

and they said there was no link, there is no link, there is no link.

Finally, in the latter part of the 1980’s, the evidence became so

compelling that at least three anomalies associated with that contamination were finally deemed service-connected and were deemed

worthy of compensation.

My hope is that this report not end the issue, but only lead to

more studies to find out what that causation really is, because we

really do not know. Again, it is encouraging. I am a great fan and

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believer in immunizations. For the record, back in the early 1980’s,

as a member of the International Relations Committee—and you

remember this well, Mr. Chairman—I offered the amendment to

create the Child Survival Fund and put $50 million in it. Now it

has grown to over $200 million to immunize the world’s children

against pertussis, measles, tetanus, and other debilitating diseases.

So I am a great believer that immunizations save lives. But if

there is a problem, we need to be candid enough, aggressive

enough, and honest enough, for the sake of our kids, to go at this

and find out what is the causation. God willing, there is no connection. But we need to pursue that aggressively.

Thank you.

[The prepared statement of Hon. Christopher H. Smith follows:]

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Mr. BURTON. Thank you, Mr. Smith.

Mr. Doyle.

Mr. DOYLE. Thank you.

Chairman Burton and members of the committee, I thank you

very much for inviting me to speak with you regarding autism and

the goals and expectations for the Coalition for Autism Research

and Education [CARE].

I want to personally thank you for your interest in expanding our

knowledge of autism and autism spectrum disorders and increasing

research funding as well as for your members in CARE. Your leadership has brought desperately needed attention to a major children’s public health issue that has been neglected for the past 50

years.

As you know, autism is a life-long disorder that significantly impacts the lives of those affected with the disorder as well as the

lives of parents and relatives. I need not tell you, Mr. Chairman,

of the profound effects autism has on parents and loved ones who

provide care for every 1 of these 1.7 million individuals. Autism

changes lives forever.

Based on the latest evidence, we can safely say that autism and

autism spectrum disorders are now at an epidemic level here in the

United States with over 1.7 million individuals affected. That is 1

out of every 150 to 170 children born.

During my tenure as Congressman, I have had numerous meetings with concerned parents, researchers, and advocates who are

struggling to get autism research and treatment issues to the forefront of lawmakers’ minds. The vast majority are frustrated by the

lack of research and essential treatment and services for their children. It is because of them, Mr. Chairman, that I became committed to forming a congressional organization for autism advocacy,

along with my good friend, Chris Smith, who I knew already had

a strong interest in autism from his work on the ASSURE Act last

session, and the Coalition for Autism Research and Education was

born.

With CARE, our major goals are to ensure substantial increase

in research funding while ensuring that families receive the highest quality treatment possible in accordance with today’s knowledge. If we accomplish these goals, the number of children born

with autism can be substantially reduced and the revolution biologic treatments of the future can be achieved for those who already have autism.

I join you in your grave concern of an autism-vaccine link and

feel strongly that we must examine what vaccines may be doing to

our children and thoroughly investigate the late onset autism-measles vaccine connection. Identifying a vaccine-autism link will help

countless individuals who develop autism after a vaccination, but

we need to fully explore all possible avenues to help those who develop the disorder by some other means.

In my view, we must learn to identify the genetic and biologic

basis of susceptibility to vaccine complications so that children at

risk can be identified and their vaccinations delayed, while children

not at risk can continue to receive vaccinations and the protection

from brain injury and death that they provide. In addition, identifying the causes of autism will not cure the 1.7 million individuals

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who already have ASD. Research must also strive toward the revolutionary biologic treatments of the future so that there is hope for

these children and adults. The decoding of the human genome

opens the door for the development of cures for autism in the lifetime of children born with autism today.

The bottom line is that we need a lot more funding for autism

research. The opinions and testimony this committee will hear are

proof of that. I am concerned that if we focus the lion’s share of

funding on one suspected cause of autism that we could unintentionally pass up vital advances in other areas. I want to provide

a lion’s share of the funding for research into both the treatments

and causes of the disorder equally for the sake of all 1.7 million individuals and families that are now living with the disorder, many

of whom were born prior to the introduction of vaccines.

Autism lasts a lifetime and often children with disorders outlive

their parents. We need to care for and educate autistic children

and adults, provide properly trained staff and educators to meet

the highly complex and specialized needs of these individuals. All

of this can become very costly over the lifetime of an individual

with autism. Steps must be taken to reduce the disability associated with autism so that more and more individuals can work and

live semi-independently.

In my home State of Pennsylvania, the Autism Society of America estimates that we have 73,686 individuals with autism. Autism

costs Pennsylvania an average of $50,000 per person per year. It

makes good sense to invest in research now so that we can get

quality services to families and realize the ultimate payoffs of prevention of this disorder in the future and cures for those children

and adults who already have autism.

Continued funding of NICHD’s 4-year-old Genetics and

Neurobiology Network must be maintained if we are to achieve this

goal. Combined with the creation and funding of at least five new

centers of excellence and three epidemiologic centers, autism research in America can reach new heights and achieve new breakthroughs for autism. Congress must continue to fund existing autism research programs without taking away the much needed

funding for them to pay for new ones. I believe that any expansion

of research programs must come with a corresponding expansion of

funding dollars.

In closing, Mr. Chairman, in western Pennsylvania, we are fortunate to have one of NICHD’s collaborative programs of excellence

at the University of Pittsburgh. This 4-year-old program is not only

making a substantive contribution to the understanding of

neurobiology and genetics of autism, it is providing guidance to

State legislators in developing surveillance and treatment centers

in our State.

I would like to extend a personal invitation to you, Mr. Chairman, and to each member of this committee to come and tour this

facility, as I have, meet the researchers and staff, and speak to individuals with autism and parents about their struggles and needs.

Mr. Chairman, I thank you for holding this hearing today and for

the opportunity to testify this morning.

[The prepared statement of Hon. Michael F. Doyle follows:]

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Mr. BURTON. Thank you, Mr. Doyle.

Let me start with you Representative Smith.

In Brick Township, as I recall—and you may have to refresh my

memory—there were some toxic chemicals or something there.

What were those chemicals?

Mr. SMITH. We had problems with a number of toxic chemicals.

As a matter of fact, we invited the ATSR, the agency that looks for

environmental pathways, to come in and they did their own study

and ruled out—based on the proximity of where the children with

autism lived and whether or not they were close to the river—— Mr. BURTON. What were the chemicals? Do you recall?

Mr. SMITH. PCBs—there were a number of chemicals. It was a

witch’s brew in essence of chemicals. They did look for a number,

and I could provide that for the record.

Mr. BURTON. I would like to have that. Did they find any mercury in there?

Mr. SMITH. I do not believe they did.

Mr. BURTON. But they found PCBs?

Mr. SMITH. Yes, and others. We are a very industrial State in the

State of New Jersey. Many of those chemicals were dumped into

the river and got into the water system.

But despite concerns about that, when an overlay of where the

children were living was done, there seemed to be no causation

that could be attributed to an environmental pathway. So they

ruled that out.

Mr. BURTON. How many were there?

Mr. SMITH. There were 4 per 1,000.

Mr. BURTON. So 1 in 250.

Mr. SMITH. And 6.7 for the full spectrum.

Mr. BURTON. Representative Doyle, you indicated that there were

170,000 children in Pennsylvania who are autistic?

Mr. DOYLE. Mr. Chairman, 73,686.

Mr. BURTON. And you said that it cost $50,000 a year to take

care of those people that are autistic.

I guess the one thing I would like to point out to anyone from

CDC or health agencies, or anyone connected with our Government—let’s just say we reduce that $50,000 to half and we only

had to spend $25,000 per person for the rest of their life to deal

with their autistic problems. If 1 in 250 or 1 in 500 people are autistic, you are talking about so much money that we cannot afford

it. We are going to have people walking around that are going to

be lost and will be causing all kinds of problems for our entire society. It could cause tragic consequences for the entire country.

So there has to be more research done to find the causes and if

possible to find ways to minimize the damage done to these people

so they can be productive members of society.

I am very happy for both of you being here and for you sponsoring and supporting and starting the Autism Caucus. I am very

happy to be a partner with you on that. Anything I can do to help

you get more money for this research, just holler. We will be glad

to do it.

With that, Mr. Horn.

Mr. Clay.

Doctor.

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Ms. Schakowsky.

Any questions for any of our panelists?

If not, thank you both for being here. I look forward to working

with both of you. I appreciate it.

Our next panel is Dr. James Bradstreet, who will be introduced

by Congressman Weldon; Dr. Cindy Kay Schneider, of Southwest

Autism Research Center in Arizona; Dr. Jeff Segal of Greensboro,

NC, formerly of Terre Haute, IN; and Dr. Sharon G. Humiston, of

Plattsburgh, NY.

Would you all stand, please?

[Witnesses sworn.]

Mr. BURTON. We want to try to confine the remarks. I know you

have prepared statements that are much longer than 5 minutes.

But if you would, I would like you to stick as close to the 5-minute

limit as possible because we have 14 witnesses today and we want

to have time for questions.

Let me start with Dr. Bradstreet.

Dr. Weldon, do you want to introduce him?

Mr. WELDON. Yes, thank you, Mr. Chairman.

It is a real pleasure and honor for me to be able to welcome and

introduce my good friend and colleague—that is, medical colleague—from the Melbourne-Palm Bay area, Dr. Jeff Bradstreet.

Dr. Bradstreet is well known to the community I live in, both as

a practicing family physician and also for a radio program that was

carried nationwide, the Good News Doctor. He is a fellow of the

American Academy of Family Physicians. With the development of

autism in his son, he has emerged as one of the leading practitioners in treatments of autism and currently receives referrals from

throughout the country from parents who have been devastated by

this disease.

It is a real pleasure for me to be able to welcome you, and I am

looking forward to your testimony as well as that of all the other

witnesses we have today.

Mr. BURTON. Thank you, Dr. Weldon.

Dr. Bradstreet.

STATEMENTS OF JAMES J. BRADSTREET, M.D. FAAFP; CINDY

KAY SCHNEIDER, M.D. FACOG; JEFF SEGAL, M.D.; AND SHARON G. HUMISTON, M.D.

Dr. BRADSTREET. As a minor introduction to myself, I had absolutely no interest in autism until it affected my son, at which

time—in a very short amount of time because of a complete lack

of local resources—I wound up having to dedicate myself full-time

to this activity which, in the end, was apparently a blessing.

[Slide presentation.]

Dr. BRADSTREET. This is just to remind us that we cannot overfocus our attention on just the vaccine issue. There is a host of environmental toxicological issues that may be interacting with the

vaccine constituents to cause problems, and this U.S. News article

points to that.

I want to point your attention to this, which is from the November 17, 2000 Oregonian. There are now over 3,000 children in Oregon—I am in Florida, but I was lecturing in Oregon and meeting

with researchers at the medical school. That makes a prevalence

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of 1 in 190 students. The national average, actually, based on recent statistics I have been able to acquire from the Internet—the

reference of which are all in my written statement—may be as low

as 1 in 140. That is an extraordinary prevalence.

I also want to point your attention to the red line, which shows

the point in time that we introduce the infant HiB vaccine and

shortly after that, the Hepatitis B vaccine to newborns on the first

day of life—what happens to the prevalence of that disorder in Oregon during that period of time.

This is from the U.S. Census on Americans with disabilities. The

blue arrow is slightly above, but that number is 1.8 percent of children under 3 being labeled as developmentally delayed—which is

a synonym for autism, in many cases or certainly autism spectrum

disorders.

If you go to the 3 to 5-year-olds, that is 2.7 percent of children

that are labelled developmentally delayed by our U.S. Government.

I would tell you that is a multi-trillion-dollar problem coming that

you are going to have to deal with, and that is a huge prevalence.

That is an epidemic by anybody’s standards.

This is the British Medical Journal article that is so famous or

infamous in terms of supposedly refuting the incidence of autismMMR relationship. Again, I do not want to over-focus on any one

particular vaccine, but look at when the infant HiB was introduced

into England with that red arrow and what happened to the incidence at that point in time. Is there an interaction between MMR

components and HiB? Is there science behind that? I would tell you

that there probably is. This is from the Mayo Clinic. Briefly, this

is a 2000 article that came out in the American Journal of Gastroenterology that said that measles virus infection is associated with

inflammatory bowel disease. The IOM report states that no cases

of vaccine encephalitis have ever been reported, but what about

this case that came out in 1999 that says that measles-inclusion

encephalitis caused by the vaccine strain of measles was proven

using PCR data.

In addition to that, the IOM report also states that MMR may

be associated with inflammatory bowel disease, but concludes that

it is still safe. This is from the recent Journal of Pediatrics about

a month or so ago that shows that there is in fact marked

autoimmunity in these children’s intestinal tract. This is most likely an autoimmune disorder in general.

This is the parent’s view of what it looks like.

That is what for 4 years of my son’s life I got to change about

three or four times a day and my wife got to change another three

or four times a day as he had chronic diarrhea. The parents have

a rather dim view of what chronic inflammatory bowel disease and

autism look like.

I want to let you know that it can be fixed. This is part of my

Christmas card from one parent thanking me for the fact that in

fact it is nice to have a child with a well-formed bowel movement.

And that child is doing extraordinarily better now that the

enterocolitis is taken care of.

Autoimmunity is a process where the immune system gets confused and turned around and thinks that maybe the child is at

fault for this.

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Myelin, which is the insulator of the brain nervous system, is

clearly a problem and there are many things that we are finding

in the kids that are abnormal that are affecting melanization. The

vaccine constituents may be part of that.

Just briefly, there is a host of credible science that autoimmunity

and vaccines are related. We are seeing in our clinic of over 1,000

children in Florida, who come to us from all over the world—in

fact, I will be leaving shortly to spend 2 weeks in Indonesia where,

after instituting a World Health Organization vaccine program,

they went from essentially no autism to an epidemic in Indonesia,

as well. I have been hired to go over there for about 2 weeks to

work with the government and teach doctors how to take care of

this disorder.

I am a clinician and I have to take care of kids. This is a little

difficult for you to read, but it is in my report. Let me just state

that this is from the Utah State University. This is cerebral spinal

fluid of a child who regressed after an MMR vaccine that shows

autoantibodies to myelin basic proteins being positive as well as

measles virus in the spinal fluid. All other variables were negative.

I would conclude from that—as did the physician and the researchers who have looked at this—that in fact that is an MMR reaction in this child since there was no measles in this child’s history.

This just shows that it is not just Dr. Singh at the Utah State

University, but myelin basic protein antibodies are prevalent and

we can find them at many different laboratories.

We also know that Hepatitis B is an issue, and this shows that

as early as 1985 we knew that Hepatitis B constituents had protein

peptides that could in fact induce autoimmune encephalitis in rabbits through molecular mimicry. These are the same proteins we

are injecting into our children.

We know that the French have identified a problem with

demelanization following Hepatitis B vaccine. We see problems

with melanization in autism every day in our facility.

This is a quickie just to show you that while there are a lot of

different peptides out there, hemophilus peptides do induce

autoimmunity to myelin basic protein from the Journal of Immunology in 1999.

Exposure to mercury and other constituents will induce the same

autoimmunity to brain elements, and that is a review article that

has over 174 references. Is mercury a problem? It is certainly in

the vaccines.

This shows just a brief overview of the amount of mercury that

is available to children through the vaccines. It is a tragedy. There

is a lot of mercury in our environment. It should not have been in

the vaccines.

This is my son’s first mercury test. That little dot on the fourth

column on the left that says toxic elements is in fact a very high

level of mercury. That is 15.7 parts per billion, which is extremely

high. This is his first post-provocational urine using a standard

procedure that has been developed; 24 micrograms per gram in his

urine.

This is a New Jersey family—for Mr. Smith. This is a heavy

metal study from a child.

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This is a 6-year-old with autism.

That is his first post-provocational urine. It shows extraordinarily high levels of lead and mercury. One would conclude that

perhaps this is an environmental exposure, so I tested the entire

family, trying to be a good doctor.

Look at Mom. Mom is a nurse, Mom has had some vaccines,

Mom has a lot of amalgams, but look at that. Mom’s mercury is not

too bad. Maybe it is not too bad.

Maybe Dad is a battery factory worker—actually, Dad is an engineer, but let us go to Dad. Dad shows very little. He does have

some amalgams as well.

How about a 4-year-old sibling that has never been vaccinated

that has grown up in the same household. There is essentially no

mercury in that child. That causes me, as a physician and as a clinician great concern. In this situation, it looks like heavy metals

are a problem. The only place I have to look—the only difference

between one child and the other—is vaccination.

Is mercury toxicity a problem in autism? That bottom line on

that graph is a mercury level that is so high it could cause neurological developmental disorders. The zinc level is almost at critical

levels of deficiency. Those two combinations cause problems.

In summary, TH–1 and TH–2 imbalance where marked TH–2 insult has occurred through the vaccination program is well documented from researchers at the University of California at Irvine.

TH–2 causes autoimmunity as vaccine-related. We see it in our

kids every day.

That is basically the issue we think that thimerosal plus environmental mercury causes the initial TH–2 skewing and

autoimmunity. Aluminum adjuvants, which are in the vaccines,

adds to that infant. Infant HiB, again, is a strong TH–2 impulse

agent. Newborn Hepatitis B is another TH–2 agent. All these so far

have been associated with autoimmune reactions, with the exception of aluminum.

Pertussis is a TH–2 potent stimulator. This is an immune system

within the child that is primed to react so that when MMR does

come along, we are going to see autoimmune reactions to brain and

to bowel. We see it every day. This is an epidemic of

neurodevelopmental catastrophe.

This is my son at the Smithsonian. That is what I think autism

must feel like to children and to families. That is a T-Rex—big

teeth, big problem. But we do know that with love, prayer, and

sound medical behavioral action, this does not have to be a catastrophe and there is hope.

The last picture is how Matthew is today. He is a happy welladjusted child, who is much better.

Thank you.

Mr. BURTON. Dr. Bradstreet, thank you for that very informative

testimony. I will have a number of questions for you.

Our next speaker will be Dr. Cindy Kay Schneider of the Southwest Autism Research Center.

Dr. SCHNEIDER. Good morning, Mr. Chairman and members of

the committee. My name is Dr. Cindy Schneider.

I would like to express my gratitude and that of the hundreds

of families I represent to Representative Burton for his scrutiny of

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the medical issues related to autism and his leadership in bringing

these concerns to your attention.

In 1995, my son Derek and daughter Devon were diagnosed with

autism. After visits to several specialists and series of medical

tests, we were left with a diagnosis and nothing more. No treatment, no plan of action, and no hope.

The following year, Dr. Ron Melmed, Denise Resnik, and I founded the Southwest Autism Research Center, a nonprofit organization dedicated to serving the needs of individuals with autism. We

developed a questionnaire for the purpose of obtaining medical, developmental, behavioral, and family histories. We began to send

laboratory specimens to researchers around the world.

This became the infrastructure of a data base which now contains information on approximately 500 children with autistic spectrum disorders, their siblings, and 200 unrelated controls. Many of

these children have undergone extensive psychological testing

through our center and hundreds have participated in clinical research trials. In this very limited time, I would like to share with

you the highlights of our findings.

We looked first at patterns of development; 60 percent of children

in our data base spoke their first word prior to 18 months of age,

indicating that early language development was usually intact. The

majority of children acquired motor skills at the expected age as

well.

Because my children experienced a distinct loss of language and

deterioration in health after their first year of life, I looked for this

pattern in other children. When asked if their child had a normal

or near-normal period of development followed by regression, nearly 80 percent of parents told us yes.

The most frequent age of regression was between 13 and 18

months. Consider the possible explanations for this deterioration.

These might include a metabolic defect which over time results in

neurological damage in a previously healthy child. Exposure to toxins in the environment could do the same. Infections, either naturally occurring or acquired through vaccination, must also be considered.

For the past 3 years, we have collaborated with researchers in

Rome on a genetic screening project. Antonio Persico and Flavio

Keller have conducted detailed evaluations of 184 families in Italy

and the United States, including 44 of our children at SARC. Investigation of four candidate autism genes revealed that three have

little effect on a child’s risk of developing autism. The fourth gene

is related to reelin, a protein critical in early brain development.

In the Italian population, carrying a variant of this gene more

than doubled an individual’s probability of having autism. In the

American subjects, the risk of autism associated with the inheritance of this allele is 19 times the usual risk; 20 percent of individuals with autistic spectrum disorders carry this gene. The inheritance of the long allele of this gene results in a lower production of

reelin. Interestingly, viral infection further reduces reelin production and may explain frequent reports of children’s deterioration

into autism following illness or vaccination.

Other research at SARC has focused on the health problems associated with autism. Of the 500 families interviewed, 48 percent

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reported that their children have a history of chronic diarrhea,

chronic constipation, or alternating gastrointestinal symptoms. The

increased incidence of bowel disease in individuals with autism has

been confirmed by multiple investigators over the past 4 decades,

yet has been largely dismissed by the physicians caring for these

children.

Our interest in the gut-brain connection intensified in 1997 when

we learned of several children with autism who experienced remarkable improvement following the administration of a gastrointestinal hormone called secretin.

In 1998, we initiated the first clinical trial of the safety and efficacy of synthetic human secretin in the treatment of autism; 30

children were enrolled in this phase one study. Improvements were

noted in language, social awareness and interaction, sleep pattern,

and gastrointestinal but were not captured on standardized psychological and language tests. We saw that some children benefited

from this treatment, yet the study of this heterogeneous group

failed to demonstrate this benefit.

Over the past year, we have collaborated with Repligen Corp.

and four other sites across the country in the first phase two clinical trial ever performed in the treatment of autism. There were 126

children who completed this double-blind, placebo-controlled study.

Each child received three doses of either synthetic human secretin

or placebo at 3-week intervals.

Unlike previous secretin studies, enrollment was restricted to

children between the ages of 3 and 6 who met strict inclusion criteria. These criteria included a diagnosis of childhood autism, a

moderate to severe level of impairment, little or no language, and

significant gastrointestinal symptoms. In addition to formal psychological testing, we asked parents to report their children’s status at

the completion of the study using a clinical global impression scale.

Treatment with three doses of secretin produced a significant decrease in the symptoms of autism in 42 percent of children, while

27 percent in the placebo group improved. Further data analysis is

underway and will take several months to complete, but early findings indicate a biochemical market which may predict secretin response.

Additional research planned at the Southwest Autism Research

Center includes expansion of our current data base through recruitment of additional families and extensive medical and behavioral

assessments of these children. Genetic testing for candidate autism

genes and screening for several metabolic defects will be performed.

An associated research priority will be the establishment of a sibling screening clinic in which younger siblings of children diagnosed with autism will undergo the same testing. The recurrence

rate of autism is approximately 5 percent, meaning that parents of

a child with autism have a 5 percent change of having another affected child. Siblings age zero to 3, the age of onset for autism, will

be evaluated every 3 to 6 months. In this way, identification of risk

factors will facilitate diagnosis and treatment at the earliest possible age. This program will also allow prospective data collection

related to the natural history of autism, its associated biochemical

distinction, and the role of suspected environmental variables.

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The establishment of these programs on a national level could

allow the genetic environmental variables responsible for the development of autism to be identified in the foreseeable future.

I thank you for your attention to this subject and look forward

to participating in the materialization of this vision.

[The prepared statement of Dr. Schneider follows:]

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Mr. BURTON. Thank you, Dr. Schneider, Dr. Bradstreet, and the

others.

Do we have copies of your studies? I would like to have as much

documentation from all of you as we can get because we are going

to have the people from HHS and FDA here. I want to submit your

studies to them—along with Dr. Wakefield’s and others—and ask

them to give us an evaluation of those studies based on their report

and their research. In other words, I want to get a comparison.

They are saying one thing and you guys are telling us something

else.

Dr. Segal, welcome. It is nice to have a Hoosier here—although

we love you guys, too.

Dr. SEGAL. I was born in South Bend, by the way.

Mr. BURTON. Once a Hoosier, always a Hoosier. [Laughter.]

Dr. SEGAL. Mr. Chairman and members of the committee, thank

you for the opportunity to speak.

In October 1999, I became a member of a club I never wanted

to join. My son was given a diagnosis of regressive autism.

I am the father of 4-year-old twins, a boy, Joshua, and a girl, Jordan. I practiced as a neurosurgeon. My son developed normally and

hit all of his milestones. He was jolly, sweet-natured, and very

bright. Before his second birthday, he started losing the language

he had acquired. He became hyperactive and inattentive to the

point that I though he was deaf.

By the time a physician confirmed the diagnosis, my wife, Shelley, and I already knew. We were devastated.

I investigated treatment options. The first treatment consisted of

occupational therapy to address his sensory issues. The other early

intervention that we chose was called ABA, or applied behavioral

analysis. ABA breaks down everyday actions into discrete steps.

The training is delivered as one-on-one therapy and involves 40

hours of work a week. It is expensive, exhaustive, and extremely

time-consuming. Most families we spoke with were on waiting lists

for ABA treatment. As time was our enemy, we moved to North

Carolina. I quit my practice and devoted my time to investigating

biomedical options.

At this point, I am pursuing three main projects. First, help my

son. If I can help him, I can help others. Next, I am researching

toxicologic causes and treatments as it relates to autism. I am

doing this in concert with the Department of Physiology at Wake

Forest School of Medicine. Finally, I am exploring pharmaceutical

options. I dug deep into my right pocket and started a drug company based on medications that are likely to be relevant to helping

those with autism. At the same time, it turns out it is probably relevant to treating Parkinson’s, schizophrenia, and other illnesses.

I have a few observations I would like to make.

The number of children with autism or related disorders is rising. Do not take my word for it and do not ask physicians. We need

to ask teachers. These kids are filling regular and special education

classrooms to over-capacity.

We have heard the argument that the number of kids with autism is static and that doctors are just better diagnosticians. I have

two points. Where are the autistic adults who were never diagnosed 20 years ago? Surely they have to be somewhere. Also, physiVerDate 11-MAY-2000 09:23 Feb 22, 2002 Jkt 000000 PO 00000 Frm 00068 Fmt 6633 Sfmt 6633 C:\DOCS\76856.TXT HGOVREF1 PsN: HGOVREF1
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cians spend less time than ever truly talking with patients and

families. More diagnoses are made by tests and machines. No laboratory test exists for autism. The diagnosis is based strictly on

clinical examination. Finally, the average time between onset of autistic symptoms and diagnosis is still years. We are not better diagnosticians.

The California Department of Developmental Services is adding

one new child with full-blown autism every 3 hours. Estimates

vary, but we are looking at approximately $2 million to raise an

autistic child to age 21.

The number of physicians who have a deep understanding of autism treatment is small. These doctors are overworked and it takes

months to get an appointment. Many of these doctors have affected

children of their own. Since autism is a systemic condition that involves that GI tract, immunologic system, and central nervous system, it requires expertise by multiple specialists. Finding all the

specialists who have an interest in treating autism can be a

daunting task.

The statistics quoted by academicians are at odds with reports

by parents. For example, the standard autism literature does not

even recognize a general connection with the GI tract and autism.

However, families report that up to 80 percent of their children

have GI problems. Standard literature suggests that only 20 percent of autistic children regress, that is, they develop normally

until age 2 and then become autistic. The majority of parents that

we see report that their children fall into the regressive or acquired

category.

Andrew Wakefield has theorized about a connection between GI

problems and autism. His work suggests that the measles virus

from vaccines might persist in GI tissue. This association might

also have a causal role in autism. This work urgently needs replication, yet many gastroenterologists conveniently dismiss his work

rather than test his theory. Incidentally, it would not be difficult

to validate or refute his hypothesis.

Eighty percent of autistic children have abnormal EEG activity

in brain areas associated with speech. It is believed that these abnormalities might contribute to language deficits. Correct diagnosis

requires at a minimum an overnight EEG. Most kids are given a

1-hour EEG, informed that it is normal, and never properly treated. Not infrequently, the EEG is normal, and a more sensitive test

called the MEG is abnormal. MEG is located in only a handful of

cities and is quite expensive. Insurance companies do not readily

pay for this test. Once correctly diagnosed, children may be given

anti-seizure medication, which can help.

Speaking of insurance companies, they do not readily pay for

much of anything that is autism-related. Laboratory tests are paid

out-of-pocket by parents and most research is being borne at the

parent’s expense.

ABA treatment is extremely expensive. It works for about half of

the children. Costs are approximately $30,000 to $70,000 a year.

The parents will frequently turn to school districts to make these

treatments available. Where one lives determines the type of treatment one receives. It is not uncommon for the school district to litigate against parents so they will not have to provide that service.

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The alternative is placing children in large classrooms. This effectively warehouses the child and minimizes potential for future

gain. Waiting lists for services are all too common.

I could spend a lot of time talking about the need for toxins research, but I would like to touch on this for just a second.

The Centers for Disease Control recently reported that 1 in 10

women of childbearing age in the United States are at risk of having newborns with neurological problems due to mercury exposure.

Until recently, vaccines had thimerosal as a preservative. Thimerosal is a preservative that contains organic mercury.

Organic mercury is widely recognized as a neurotoxin. In one

study, lower or scores neurologic function tests were found years

later in children who had been exposed prenatally to intermittent

doses of methyl mercury. These doses happened to be from dietary

exposure at levels that had been previously thought to be safe.

The vaccine manufacturers, to their credit, have stopped making

new vaccines with mercury as a preservative. But many of these

vials still sit on doctors’ shelves. Also, RhoGAM is given to RH negative mothers and this medication still has thimerosal.

As an anecdote, I spoke with two fertility doctors. They were not

aware of the mercury issue. They were livid that this type of medication had a preservative that had ‘‘cleared’’ safety tests and was

being given to a pregnant woman.

With more vaccines being recommended to an already-full vaccine schedule, and many vaccines administered earlier in life, the

potential for mercury toxicity in children is quite real. The symptoms of mercury poisoning and autism are quite similar.

I recently analyzed 250 hair samples and found that 30 percent

of these children had tested two standard deviations above the

mean for various metals: aluminum, arsenic, and antimony. These

agents are ubiquitous in the environment. It is my belief that autistic children may not be able to clear these toxins from their bodies.

Chelation treatment is one way to remove metal toxins from the

body. It uses compounds that have a propensity to grab metal toxins. There are many unanswered questions regarding chelation. I

say that historically the reputation for chelation is quite poor. And

I say this as a physician who had never previously entertained the

idea of chelation for any chronic condition. It is extraordinarily difficult for a practitioner to get funding to study chelation. It is just

as difficult to get doctors to consider it as a viable treatment.

My scientific work is focused on analyzing genes and proteins

that detoxify heavy metals in autistic children. My hypothesis is

that some children are genetically predisposed to the inability to

detoxify the metals to which they are exposed to in the environment. These metals may come from vaccines, food, or the environment. The major detox pathway for heavy metals is

metallothionein or MT. I am researching whether or not these children have defective MT genes or if they are unable to make appropriate amounts of this protein in response to the insult. This could

explain why not all children exposed to the same environmental insult develop autism.

I will close, knowing I am well over the time.

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We need immediate and abundant funding for research, particularly treatment. We need to fund fellowships to increase the number of skilled doctors who are treating autism. We need to mainstream autism as it relates to insurance payments. It is a biological

condition and should not be constrained by policy limits on mental

health coverage.

We need to standardize payments for ABA treatment across the

country. It is unfair that some families are on waiting lists for 2

years to access coverage.

We need to get the vials of thimerosal-containing vaccines off the

shelves through recall.

Mr. BURTON. Amen.

Dr. SEGAL. We have adequate stocks of vaccine. It is not a problem at this point. We need to clear the shelves. And doctors do not

know what is sitting on their shelves. We also need to remove thimerosal from RhoGAM.

We need to seriously test the hypothesis that vaccines are not always as safe as is currently believed. In addition, combinations of

vaccines have potential risks that have never been explored. I

clearly understand the public health import of diseases we are preventing, but we need prospective studies.

Finally, licensing boards need to be less heavy-handed to doctors

offering off-label treatment to families that are desperate for treatment. Off-label use of medications is common in all fields of medicine. The standard by which these physicians should be judged is

risk versus benefit.

Thank you for your time.

[The prepared statement of Dr. Segal follows:]

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Mr. BURTON. Before we go to the next witness, let me tell you

that every Congressman who got a flu shot from the Capitol Hill

physician—they do not know this—but they all had thimerosal injected into their bodies. They all had mercury put into their bodies.

I got the shot and afterwards I looked at the insert and found that.

There are a lot of people who believe—like you do—that a number of senior diseases, like Alzheimer’s, could be contributed to by

us having injections of mercury. And nasal sprays the doctor gave

me, the preservative was thimerosal. So we are getting mercury in

all kinds of things, not just for children, but for adults as well.

So to my colleagues, if you had a vaccination for flu—and I went

over to see the doctor, who is a wonderful doctor and a good friend,

and he did not know it was in there.

Dr. SEGAL. And it is followed with a tuna fish sandwich, to boot.

[Laughter.]

Mr. BURTON. Now, do not start telling me I cannot eat tuna fish.

[Laughter.]

Dr. Humiston.

Dr. HUMISTON. Thank you for inviting me to speak on behalf of

my son, Quinn.

I wish you could meet Quinn. He has big eyes as brown as chocolate, and when he grins, you see those two big front teeth. He has

the smooth, lean, muscular limbs of a child for whom movement is

perpetual. You would never guess when he is sleeping that with

that perfectly handsome face and that perfect 8-year-old body that

Quinn has almost no language, that Quinn will bite and claw people in fits of aggression, which at times, appear as spontaneous and

uncontrollable as a seizure, and that Quinn, on a bad night, can

get along on as little as 3 hours of sleep.

You think you have all the answers until you become a parent.

I did not even know all the questions. The main question my husband and I have had to address is, what are we going to do now

to help?

We initially decided to use behavior analytic treatment, an educational technique derived from research on operant condition. A

one-on-one therapist gives the child short and clear instructions for

a desired behavior. For example, Say ‘‘Hi.’’ A correct response gets

an immediate reward. For example, the therapist smiles and says,

‘‘Great job.’’ An incorrect response may be ignored or may trigger

the therapist to prompt the child. As recommended, Quinn received

40 hours each week of one-on-one therapy. Studies at UCLA had

shown that many children had significant improvement with this

technique and replications at three other sites confirmed their findings.

When I say this, it sounds so rational. We were faced with this

devastating diagnosis and we went through the literature and

talked to every expert we could find. We found an intervention on

which there was encouraging evidence, so we threw ourselves, day

and night, into getting and keeping the therapy in place. I assure

you that it did not feel rational at the time. I had the panic-stricken urgency of a person staring down the barrel of a gun. My son’s

brain development, I believed, depended on me finding the right

therapy in time before we was too old to be helped.

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Autism and mercury experts at the University of Rochester have

advised us not to get chelation therapy for Quinn. I was told that

chelation is not recommended even for acute mercury poisoning.

Brain damage done by mercury poisoning is irreversible. You do

not see improvement after chelation. Finally, I was told that the

safety of this intervention is not known.

My husband and I have tried other interventions: a phenol-free

diet, a gluten-free and casein-free diet, medications including

Ritalin and Prozac, and cranio-sacral massage. We tried to get secretin and found a place where we could get a dose or two for

$10,000, but by then evidence was accumulating that it was not effective.

There have been more questions. Because I am a pediatrician,

and particularly because I used to work for the CDC National Immunization Program, many people have asked me if MMR causes

autism. As you are well aware, two exhaustive independent reviews

have become available on that topic. The American Academy of Pediatrics, of which I am a fellow, has made a summary of their review available to all pediatricians. They report that the available

evidence does not support the hypothesis that MMR vaccine causes

autism or associated disorders. Separate administration of measles,

mumps, and rubella vaccines to children provide no benefit over

administration of the combination MMR vaccine and would result

in delayed or missed immunizations.

The American Academy of Pediatrics is dedicated to the health,

safety, and well-being of children. The AAP has proven itself to be

absolutely dedicated to vaccine safety. They quickly withdrew their

recommendation for rotavirus vaccine at the first sign of a problem

and recommended the move away from thimerosal-containing vaccines even during the information-gathering period.

These actions have given me added assurance of their openmindedness regarding the MMR-autism hypothesis and have added

weight to their findings.

Similarly, the Institute of Medicine, the supreme court of medicine, convened the Immunization Safety Review Committee to address this issue, and they found ‘‘that the evidence favors rejection

of a causal relationship at the population level between MMR vaccine and ASD.’’ The committee felt that the relationship been MMR

and autism would be extremely rare, if it occurred at all.

The next question is about thimerosal. And we all look forward

to IOM’s review of this topic. I am aware of an interesting recently

published report from the University of Rochester that shows that

none of the blood mercury levels observed in full-term infants studied shortly after vaccination exceeded the most recently revised

lowest level of maternal blood mercury considered to represent potentially significant exposure to the developing fetus.

So what are we going to do now to help? Despite intensive therapy, my son has not been helped dramatically. And that is why I

am here today. I am absolutely certain that we need more research.

I am pleased that IOM was asked to review the question of MMR

and autism, and I am pleased that they will review the thimerosal

question. I am pleased that NIH is proceeding with the scientific

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cellence in autism and I trust that funding is assured for the future.

I am excited by the creation of the congressional Coalition for

Autism Research and Education and most especially by the Children’s Health Act of 2000. I am encouraged to hear that the CDC

has created a new Center on Birth Defects and Developmental Disabilities. All this activity is especially heart-warming for a parent

because autism research has been significantly neglected up to

now.

We need good autism epidemiology in the United States to determine risk factors and true rates. We need basic science research

into the nature and causes of this disorder. And we need clinical

research to determine what works and what does not, what is safe

and what is not.

As we all know, appropriations are the key. A financial investment now could, in maybe just a few years, prevent another mother

from having to face the questions I have had to face. There is a

motto: ‘‘You can have it fast, good, or cheap, pick two.’’ In autism,

research, we cannot afford to go slowly or have poor quality. That

is why parents want Congress to fund high-quality research at the

high level it deserves given the disorder’s frequency, its devastation, and notable past neglect.

And we need significant research funding that comes with a commitment to the long term. Scientists are poised on the brink of success, but it may not come tomorrow. Like the families of autistic

people, Congress has to be in this for the long haul.

How should the autism research agenda be set? Foremost, scientists should be encouraged to follow the cues of epidemiology and

basic research. Listen to parents carefully, but do not neglect to follow through based on the leads from science.

Autistic families need better services—educational services for

the autistic individuals, parent training for handling autistic offspring through their lifetime, and respite services that are so essential in coping. Finally, parents need to see residential care facilities in place that will help with the question my other child

asked me, what is going to happen to Quinn when you and Daddy

die?

The question for this committee and all of us is the same as the

initial question my family faced, what are we going to do now to

help?

[The prepared statement of Dr. Humiston follows:]

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Mr. BURTON. Let me just say that I admire your view, Doctor,

that the health agencies are doing a good job. And I think for the

most part they are, but I would like to bring to your attention that

the rotavirus vaccine—the advisory committee that recommended

that—was kind of split. Some of the people thought there should

be more testing done on the rotavirus vaccine. But the chairman

of the committee had financial interests in the company that manufactured a rotavirus vaccine.

Dr. HUMISTON. The chairman was John Motley, who had no conflicts of interest at all.

Mr. BURTON. Let me just tell you that we have already checked.

We looked at the financial disclosure forms. The chairman—— Dr. HUMISTON. It could not have been the Chair. He has no—— Mr. BURTON. Well, there were a number of people on there who

had financial interests in the rotavirus vaccine. And that vaccine

was put on the market. Within a year, we had one child die and

a number of them had serious problems. We are looking at and

have found some financial conflicts of interest among other people

who are in the decisionmaking process.

That is one of the reasons why many people in Congress are very

concerned about things like the report we just received. And that

report was not categorically saying that the MMR vaccine was not

a cause of autism. It did not conclude that, if you read the whole

report.

Let me just ask a couple of questions here.

First of all, does the MMR vaccine, when it is being produced,

does it include in any way in the production mercury? Do any of

you know that?

Dr. HUMISTON. It does not. MMR does not contain thimerosal. It

contains no preservative because it is a live vaccine.

Mr. BURTON. I am asking in the manufacture of it because in the

manufacture, we have been told—and I do not know that it is

true—there was mercury in some of the production of the vaccine.

But you are saying that categorically, that is not——

Dr. HUMISTON. No, because it is a live vaccine. The live vaccines

do not need preservatives.

Dr. SEGAL. I would say that we do not know. I would say also

that in the manufacture of the drug we are working on, there is

mercury in the process and we take pains to remove it at the end.

We think that it is all out.

But I think the answer to your question is that we do not know.

I do not know that—— Mr. BURTON. But there is mercury used in the process?

Dr. SEGAL. I do not know. I do not think anyone here knows.

Mr. BURTON. We want to check on that and find out about that.

Mr. Bradstreet, are you stating that the combination of the thimerosal-containing vaccine with the MMR vaccine causes

neurologic, immune, and GI problems in susceptible children?

Dr. BRADSTREET. I think that would be incomplete, but I am saying that in part.

I think there are a number of environmental factors that are

skewing the child’s immune system toward a predilection along the

autoimmune lines. I think that thimerosal is one of those issues.

The aluminum adjuvants is another issue.

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Then the other vaccines I discussed—the Hepatitis B vaccine and

HiB—also are capable, as is pertussis—of pushing that TH–2 response so that by the time we get to the 15-month level or so and

we give the MMR vaccine, it is the next TH–2 potential responding

vaccine that the kids get. For some of the kids, it is just too much.

However, I have a number of kids who, immediately after the

Hepatitis B vaccine—within days—seem abnormal and never recover and evolve autistic-like symptoms. I have heard the same

thing after pertussis.

So it is not just MMR by any means, but there is a significant

number—perhaps half of our families—who now claim they had a

perfectly healthy child and within days—10, 14 days, whatever— their child was completely changed following the vaccine schedule.

That, in and of itself, is not conclusive. But it certainly causes

one to look very, very hard at that subject. Epidemiology, in and

of itself, is not going to give us that answer.

Mr. BURTON. You talked about the mercury. That was in the

Hepatitis B vaccine as well?

Dr. BRADSTREET. Yes, as well as in the HiB vaccines. Almost all

the HiB vaccines have mercury in them as well. So those are multiple sources for mercury.

Mr. BURTON. That is exactly what happened with my grandson,

within days after his.

Dr. Bradstreet, are you seeing improvements with the treating of

children to remove mercury? Do these children appear to be more

vulnerable to other toxic metals?

Dr. BRADSTREET. I think that something—and I am not sure

what it is at this point in time—has wounded the body’s normal

and natural metallic defense. We have a system in the body designed to prevent environmental toxins like mercury and lead and

other things from being toxins within the body. Many things protect the body. However, for whatever reason, certain children seem

to be unusually vulnerable to that.

There is abundant data now available that individual variability

at the time of the mercury exposure to thimerosal—we do not know

how susceptible that child is. We do not know what other sources

of mercury he has had, whether it was RhoGAM or diet or environment. We do not know how much he is going to get. And we do not

know the status of his ability to defend against that mercury. We

kind of cavalierly give it assuming that because it is below some

sort of EPA threshold—although, with the combination of the multiple vaccines that is not true—that it is going to be safe.

I think that there is something about certain children that

makes them very vulnerable to mercury.

Mr. BURTON. I have some more questions.

Mr. Horn.

Mr. HORN. Thank you, Mr. Chairman.

Dr. Segal, I believe you mentioned RhoGAM, and the content of

thimerosal.

Dr. SEGAL. That is accurate, yes.

Mr. HORN. What would be the behavioral changes if one used

that consistently?

Dr. SEGAL. I am not sure I understand that question, but let me

take a stab at it.

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The medication is RhoGAM, which would be given to RH negative mothers to prevent a reaction with children in terms of attacking their blood cells.

Thimerosal is used as a preservative. It is given to the women— at this point—while they are still pregnant. The mercury preservative would be able to cross through the placenta and get into the

developing infant. The theory would be that it would harm the developing fetus, at which point you would see neurodevelopmental

abnormalities.

Mercury is an accumulative problem. That is, as you continue to

be exposed to mercury, the body struggles with trying to remove it.

When it builds up to some critical level, which cannot be predicted

in the individual child, we have the potential to see

neurodevelopmental problems.

Mr. HORN. So this is nothing to do with Rogaine, which relates

to hair, and so forth? [Laughter.]

Dr. SEGAL. Not to my knowledge.

Mr. HORN. You have 2 million people across America who will

wonder.

Dr. SEGAL. I think they can rest comfortably. [Laughter.]

Mr. HORN. Dr. Segal, do you think the genetic component of this

problem may be the inability to these children to clear toxins and

metals from their bodies?

Dr. SEGAL. I think that is the first step. I think there are multiple problems that are individually necessary but not sufficient. I

think the first step is a genetic predisposition. I think that predisposition relates to the ability to detoxify against environmental

insults.

Mr. HORN. Do you agree with the comparison of the symptoms

of autism and the symptoms of mercury toxicity as similar? Do you

see that?

Dr. SEGAL. I think the parallels are astounding, yes.

Mr. HORN. And that has been a lot of your research?

Dr. SEGAL. That is correct.

Mr. HORN. So you are speaking from scientific research?

Dr. SEGAL. That is accurate, yes.

Mr. HORN. Thank you very much for your testimony. I was very

interested in it.

Dr. Schneider, are you seeing children with increased toxicity to

other substances, such as arsenic?

Dr. SCHNEIDER. Absolutely. My own children have high levels of

arsenic. After some research, I learned that is because I live in the

State of Arizona where mining has been and still is occurring and

our water supply comes from Colorado where the same can be said.

Gold is mined with cyanide. Copper is minded with arsenic. It is

so prevalent in the Phoenix water that no one is using Phoenix

water. We have to get our water from Colorado, which really is not

much better.

I have a reverse osmosis system in my household, and I mistakenly thought that removed heavy metals. I found recently that was

not correct. I had to pay $5,000 to put in a water system which did

remove arsenic and mercury from our water supply.

Mr. HORN. That is the Phoenix water system?

Dr. SCHNEIDER. Yes.

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Mr. HORN. Do you see that throughout Arizona?

Dr. SCHNEIDER. I have not looked throughout Arizona, but certainly there are metal-toxic children throughout Arizona.

Mr. HORN. We see the same thing in Los Angeles where we have

had various types of industries, small and large, where the metals

just get into the underground water supply. That has become a

major problem. I know EPA has studied this. What studies have

you seen that lead to a different—arsenic as it goes around—some

say you cannot deal with it because it is in this or that. I just wonder what kind of research you have seen where it is clear that it

is hurting people substantially.

Dr. SCHNEIDER. Quite honestly, I do not do that kind of research

and I am not as familiar with it as I intend to be because I was

focusing more on the mercury aspect. But I find now that mercury

is not our only problem. We are exposing our population to many

toxic metals.

Mr. HORN. We understand that typically children with autism

are first diagnosed by a developmental specialist or psychiatrist

and that the physical problems with these children are not addressed.

What do you think must be done to ensure that these children

receive appropriate medical care?

Dr. SCHNEIDER. At our research center, we have initiated a physician outreach program, which is now in the stages of developing

educational material for physicians, planning conferences for physician education. The reality is that most parents diagnose their children and then go to their pediatrician who tells them that they do

not think so. Then they go back again and eventually get referred

to the proper specialist and have the diagnosis confirmed.

In my own case, our pediatrician is a dear friend of mine and I

have the greatest respect for him, but he did not know autism

when he saw it. And that is very, very typical. We need to change

that because, as many of us know, the earlier the child is diagnosed and the earlier the intervention is begun, the better the

child’s chances of having a partial recovery.

My own children are 81⁄2 and 91⁄2 years old now. I would say the

clock is ticking.

Mr. HORN. In some of Chairman Burton’s earlier hearings, we

found there were a lot of medical journals of which there are probably a couple hundred—I have seen them in our library in Long

Beach—that have glowing reports of this or that and they do not

really tell you the effects on it. Do you have some feelings that the

various professional groups and segments of this and that specialist, and some of their yearly meetings—they ought to have meetings that relate autism to all of the things that they might not—

they go through medical school and there is great ignorance there

in many ways, just like nutrition was, which was a simple thing.

Doctors ought to know something about nutrition. Well, doctors

ought to know something about this.

Now, how do we communicate with them where they read it, and

they see it, and it means something?

Dr. SCHNEIDER. You are absolutely right because the reality is

that pediatricians or family practitioners were not educated in the

area of autism. Their image of autism is a child rocking and bangVerDate 11-MAY-2000 09:23 Feb 22, 2002 Jkt 000000 PO 00000 Frm 00087 Fmt 6633 Sfmt 6633 C:\DOCS\76856.TXT HGOVREF1 PsN: HGOVREF1
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ing his head on the wall. Many of our children do not do that,

thank goodness, yet still have autism.

So the physician outreach is a very important project for us. But

what we realized when we spoke to the residency programs in our

city is that pediatricians in training right now—a pediatrician has

4 years of college, 4 years of medical school, and 3 years of residency—in that training process, they talk about developmental disabilities for about 1 month, and autism is only one portion of their

focus. So there really is very little exposure to this area.

If you think about what happens in terms of medical education

after training, it is primarily in the form of conferences. I am sorry

to say that most conferences are sponsored wholly or in part by

pharmaceutical companies. The message they want to get across

has much to do with treatment of the condition for which they have

a drug.

So you have to understand that it is up to the physician to educate himself or herself after training and to take into account the

sources of the information they are receiving.

Mr. BURTON. Thank you, Mr. Horn.

Mr. HORN. Thank you.

Mr. BURTON. I will tell you my son-in-law is a doctor. And many

doctors pretty much take at face value the recommendations and

the research done by the CDC and the FDA. I can tell you that

even here on Capitol Hill—like I was talking about the vaccine we

get for the flu—I do not think any doctors up here even knew that

there was mercury or thimerosal in it.

Mr. Blagojevich.

Mr. BLAGOJEVICH. Thank you, Mr. Chairman.

Dr. Humiston, our staff has just checked with Merck, the only licensed manufacturer of the MMR vaccine. The staff was told—and

perhaps you can confirm this—that there is no mercury in that

vaccine. Is that consistent with your understanding?

Dr. HUMISTON. Yes. My understanding is that there is no mercury and there is no mercury in the process of making it. It is thimerosal-free, as opposed to the vaccines that have mercury in the

process but not actually in the vaccine.

Mr. BLAGOJEVICH. Thank you very much.

Thank you, Mr. Chairman.

Mr. BURTON. We will check on that.

Dr. Weldon.

Mr. WELDON. Thank you, Mr. Chairman.

I have a question for Dr. Bradstreet.

You have been doing a lot of research—and really any of you can

comment on this—and you have talked to a lot of researchers.

Have you encountered any lack of willingness or intimidation to research in areas that might suggest that there are problems with

vaccines in terms of its impact on the careers of researchers or

their ability to get funding in the future? Have you encountered

any comments to that effect?

Dr. BRADSTREET. Yes. Actually, we work with researchers at several major university medical schools around the country. Many of

them or their department chairmen have related back to us that

there is significant fear and apprehension about doing a study that

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maceutical industry for future funding of research. Many pediatric

departments or infectious disease or immunology departments

around the country at medical schools are completely dependent for

a vast majority of their research budget and operating expenses on

granting from the vaccine manufacturing companies. Many of those

vaccine manufacturers make a host of different drugs.

If you look then at the potential liability issue—determining for

example that thimerosal may be harmful to children—what that

means from a liability perspective, a beginning of life neurologically

damaged child that has a life expectancy similar to yours or mine,

70 or 80 years of care—that is cataclysmic. So they will go a long

way to potentially suppress research along these lines.

It is something that needs to be addressed and there need to be

independent sources of funding completely apart from the drug

companies.

Mr. WELDON. Have any of the other witnesses encountered comments to that effect? Or would you rather not comment on this

issue?

Dr. SEGAL. I would rather not comment on that issue. I would

say, without getting into detail, the answer is yes. We have encountered that difficulty. But as we are trying to make in-roads in

terms of additional research projects, I feel any comment I could

make would be fragile.

Dr. HUMISTON. At the University of Rochester, because my developmental pediatrician is one of the researchers for the centers of

excellence, I am aware of what they do. They are getting funding

to look at vaccine safety issues.

Mr. WELDON. I have a question about the incidence.

The incidence in boys is four times higher than the incidence in

girls. The incidence in the population is estimated at being—some

say as high as 1 in 100—most likely 1 in 500 or somewhere in between, according to a lot of researchers. But that doesn’t that mean

that the incidence in boys is substantially higher? Aren’t we talking about it being somewhere between 1 in 50 and 1 in 250?

Dr. BRADSTREET. Just to be specific, we are talking about prevalence, which is the amount of disease in the population of children

or boys. Incidence would be the new cases that are coming on-line

per population on an annual basis. That is probably very high as

well, although there is much less incidence research being done as

compared to prevalence.

We know that it is very prevalent. A lot of children have this.

If you look at Oregon as an example—and all the citations are on

pages 5 through 8 of my testimony—clearly Oregon is very conservative. The State is run by a physician.

Mr. WELDON. If I could interrupt you for a second, the Oregon

data you showed was less than 1 in 200. Is that correct?

Dr. BRADSTREET. Yes, 1 in 190 in Oregon.

Mr. WELDON. What does that make it in boys?

Dr. BRADSTREET. It is probably something like 1 in 50 or 1 in 70

in boys if you factor the four to one difference in occurrence rate

in boys.

Mr. WELDON. Dr. Segal, you kind of made the comment as a joke,

but this issue—I have had CDC officials in my office talking about

whether we have an epidemic or not, and they cite how the DMS–

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3 was changed. But you made an excellent insight. If we are just

diagnosing it better, what happened to all the adults? Is anybody

researching that or looking into that?

Dr. SEGAL. If it is a question of diagnosis, the adults have to be

somewhere. They did not disappear. The problem is that they are

not there. The numbers have gone up. I think that is the only conclusion we can make.

Mr. WELDON. But nobody has done a research study looking at

adults who are in institutional care, have some kind of psychiatric

disability, who were perhaps previously diagnosed as mentally retarded, who may have actually had autistic spectrum disorders.

Nobody is looking into that, to your knowledge?

Dr. SEGAL. To my knowledge, no one is. I would comment that

Dr. McDougle, when he was at Yale, had a great deal of interest

in adult autistic patients. So he may be able to comment on that

further. He will be in the third panel.

Mr. WELDON. I know I am running out of time. I just have a

question for Dr. Humiston.

You quoted from the IOM study that the committee concludes

that the evidence favors rejection of a causal relationship at the

population level between the MMR vaccine and autistic spectrum

disorder. I fully expected them to say that because if they did not

say that and it got out in the press, then parents all across America would start rejecting the vaccine and we could have a huge explosion of measles.

But then they did go on to say in the next section that they did

note that their conclusions did not exclude the possibility that

MMR vaccine could contribute to ASD in a small number of children because the epidemiologic evidence lacks the precision to assess rare occurrences.

I assume you agree with that section of the report as well.

Then they further went on to recommend further areas of research—and they have several areas of research they recommend—

to include to develop targeted investigation of whether or not measles vaccine strain virus is present in the intestines of some children with ASD.

Essentially, they are calling for what I had encouraged them to

do when I testified before them, to encourage NIH to fund the duplication of Dr. Wakefield’s and O’Leary’s work.

I assume you have seen Dr. Wakefield’s micrographs and slides

of inflammatory bowel disease in these kids, and you have reviewed Dr. O’Leary’s PCR research showing the presence of measles virus particles in the intestines of these kids.

Dr. HUMISTON. I have not reviewed his micrographs. I am not a

gastroenterologist. I am an emergency medicine pediatrician.

Mr. WELDON. I am an internist, but I have ended up having to

get very familiar with all this.

If you listen to all the press reports, they loaded up at the beginning of the press report that IOM says this is fine. Then they go

on and—at least the better coverage of what I saw of all this—to

say that further research is recommended. I do not want to accuse

the IOM of talking out of both sides of their mouth. They were in

a very, very delicate situation.

87

I have some concerns about the way the study was passed

through some of the reviewers, or some of the witnesses who have

had a track record of being critical of this work. But I think we

have a very serious issue here. You cannot refute a clinical and

pathologic report with an epidemiologic study. You cannot do that.

It is bad science. You have to fund an attempt to duplicate the clinical study and the pathologic study.

Would you agree with that?

Dr. HUMISTON. I am in agreement that the study should be replicated. I am in agreement that epidemiology alone does not refute.

What IOM reviewed was not just simply two or three articles. It

was many.

Mr. WELDON. I know.

Dr. HUMISTON. And I did have the privilege of being in the room

during the IOM report. So I was privileged to hear about changes

in autistic brains of children in areas where the brain develops and

is used for different things at different times. So the

neuropathologist was describing how this could explain how we see

regression.

There was one researcher there who showed how blood spots

taken on the first day of life had different levels of vaso-active intestinal protein present in day 1 of children with autism, different

levels than controls. I think IOM took Dr. Wakefield’s hypothesis

very seriously, as I think it deserved to be taken very seriously.

I also do not think that when you say in a light way that this

is what you expected of IOM—I have great respect for those scientists. They came from many fields. And many of them did not

come from vaccines.

So I think that taking that lightly is a disservice to those scientists and to the work of people who are moving forward with genetic explanations.

Mr. BURTON. We have to have a vote. We have 6 minutes left on

the clock.

Mr. WELDON. I just want to clarify one thing.

You are accusing me of taking it lightly what they were doing.

I do not like that at all. I consider this report a good report. I was

pleased with the results of this report. But for them to spotlight

and put the focus of public attention on the serious issues being

raised about the safety of this vaccine by Dr. Wakefield, it is going

to cause parents—just like it happened in England—to quit giving

the vaccine. So they were in a very awkward situation, in my opinion.

I personally believe that there is a problem with this vaccine.

And there is a subset of children who have a genetic predisposition

to having problems with this vaccine. But further research is needed.

I do not want to be accused of taking their findings lightly. I consider this basically what they should have done. They did what was

needed.

Mr. BURTON. Let me just conclude—and I hope you will come

back for the third panel, Doctor, because I value your input.

Let me just say to you that they did send that report out for review to people from various pharmaceutical companies, and there

88

were changes made, as I understand it, or corrections or perfections

done on that report. I want to find out what those were.

Let me just ask two quick questions.

Does secretin cost $10,000 for two doses? I think my grandson

got secretin and I know it did not cost that.

Dr. SCHNEIDER. There certainly are some practitioners who

charge that much. That is absolutely true.

Dr. BRADSTREET. Mr. Chairman, $200 to $300 for what used to

be available is no longer available is a fairly common cost to the

physician. Relatively commonly, physicians double the price of

something that they buy. So if they buy a vaccine for $20, they

would like to sell it to the patient for $40. So that is an outrageous

price.

Dr. SCHNEIDER. Our regular pediatrician would not give it us.

We were trying to find any source.

Mr. BURTON. And my other question is, can chelation remove

mercury from the brain?

Dr. BRADSTREET. There is no evidence of that at this point in

time.

Mr. BURTON. Anybody else?

Dr. SEGAL. I agree. There is no evidence one way or the other.

In fact, I spoke with two mercury experts. One suggests that mercury stays in the brain indefinitely. The other said that mercury

is cleared within 50 or 75 days.

The bottom line is that nobody knows at this point.

Mr. BURTON. We need some research on that point as well.

Dr. SEGAL. Yes, we do.

Mr. BURTON. We will dismiss this panel. Thank you very, very

much. We really appreciate it.

We would like to have your documentation and reports in total,

if we can get those, so we can submit those to the health agencies.

Thank you very much.

We will be back. We will stand in recess to the fall of the gavel

and go to our third panel as soon as we get back. It should be

about 10 minutes.

[Recess.]

Mr. BURTON. We have a very large second panel. It is very, very

important, though, that we cover all this territory. There will be

other Members coming back from the floor in a minute.

[Witnesses sworn.]

Mr. BURTON. We will start with Dr. McDougle. You are recognized.

89

STATEMENTS OF CHRISTOPHER J. MCDOUGLE, M.D., RILEY

CHILDREN’S HOSPITAL, INDIANA UNIVERSITY SCHOOL OF

MEDICINE; ANDREW WAKEFIELD, M.D.; WALTER SPITZER,

M.D., FACULTY OF MEDICINE, MCGILL UNIVERSITY, MONTREAL, CANADA; BOYD E. HALEY, DEPARTMENT OF CHEMISTRY, UNIVERSITY OF KENTUCKY; DAVID G. AMARAL, MIND

INSTITUTE, UNIVERSITY OF CALIFORNIA, DAVIS; DR. ELIZABETH MILLER, PUBLIC HEALTH LABORATORY, ENGLAND;

AND DR. MICHAEL D. GERSHON, DEPARTMENT OF ANATOMY

AND CELL BIOLOGY, COLUMBIA UNIVERSITY

Dr. MCDOUGLE. Thank you very much, Chairman Burton and

committee members. Thank you for the opportunity to come and

speak with you today.

In addition, I would like to thank you personally for your recent

efforts to assist our work in autism at the Riley Hospital for Children in Indianapolis. It is very much appreciated.

I was asked to come today to talk a bit about our current clinical,

educational, and research activities at the Indiana University

School of Medicine. I am currently the chairman of the Department

of Psychiatry as well as the director of the section of child and adolescent psychiatry and the chief of the Autism/Pervasive Developmental Disorders Clinic.

I have been doing research and clinical care in the area of autism

for the past 12 years or so. I came to Indiana in 1997, and at that

point wanted to establish a formal autism clinic. At that time, we

had approximately 100 children with a diagnosis of autism and

other pervasive developmental disorders in our clinic. We brought

those children together into a formalized manner and then began

to build a clinical team.

At that time, I was the only child psychiatrist on the team and

we had one clinic coordinator. We soon realized—once we got the

word out that we had a formal clinic—that we needed to expand

our clinical operation significantly.

We currently have an active clinic census of over 500 children.

So in 3 years the census within the clinic has gone from 100 to 500.

The disturbing and alarming part of that is that our waiting lists

are out 9 months in advance now to bring children and families in

for a new evaluation. So we have 9 months of people on the waiting

list to even begin to get in to see us. At the same time, we are still

trying to provide good care for the 600 current families within our

clinic.

In an effort to meet some of these clinical demands, we have

begun to hire additional faculty. I have added another full-time

child psychiatrist, a nearly full-time behavior therapist, and a social worker to work with families to provide resources and help

them with a number of the sticky issues they face.

Despite those additional clinical personnel, the waiting list persists. So I can certainly say firsthand that we are working very

hard in Indiana. Autism is not rare. And we are having difficulty

keeping up with the pace of personnel, despite adding additional

personnel.

One problem with providing clinical care is that the reimbursement for such care is very poor. It becomes an issue as to how you

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lation of your clinic when insurance reimbursement is often nothing or minimal. So that is an issue that I think needs to be addressed to a greater degree.

With regard to research, I am an expert in the area of

psychopharmacology. I would say I am pretty good at diagnosing

autism and related disorders and treating symptoms of autism that

can become quite problematic. These symptoms—many of which

have not been mentioned yet today—include aggression toward

self, aggression toward others, property destruction, hyperactivity

and inattention, interfering repetitive or ritualistic behavior, as

well as the core disturbance of autism, which is a disturbance in

the ability to relate appropriately to other people.

And we have a number of medicines we are studying in an effort

to try to reduce some of these symptoms so that the child may be

better able to participate in non-drug treatments, to be able to sit

still and pay attention in speech therapy and other educational activities. But many times these symptoms I mentioned are so severe

that the child cannot even get into a school or educational setting

to benefit from these alternative treatments.

I would like to thank the National Institute of Mental Health.

Approximately 31⁄2 years ago they instituted a program to develop

research units on pediatric psychopharmacology. They put out an

RFA specifically to develop centers focused on autism. We were fortunate enough to be chosen as one of those centers in addition to

four others across the country.

We recently completed our first study of a medication through

this program with a medication called Risparidone, targeted really

at some of the more severe symptoms of autism, including aggression, self-injury, and irritability. This was a double-blind, placebocontrolled study. We entered 101 children in adolescence into this

study, which will make it by far and away the largest medication

study ever conducted in autism to date by at least half—twice as

large. So the idea of having multiple centers working together to

get a larger sample size more quickly makes a lot of sense. I would

like to see the RUPP networks continue to be funded.

In addition, we have begun to explore a number of what we call

investigator-initiated studies. When we read the basic science literature, we get ideas about medicines or compounds that might be

helpful for some of the symptoms of autism. We then go and try

to generate some pilot data that if there is something to it we then

apply for Federal funding. We have initiated a number of studies

with some of those compounds.

The other areas of research in autism to date that I think are

hopefully going to be fruitful include those that have been successful in investigating disorders in other areas of medicine over time,

and that includes genetics. Certainly there have been large dollars

put into the genetic research of autism to date without really significant results.

What that tells us is that this is a complex disorder, that there

may be multiple genes involved in autism, and my guess is that

eventually we may find in fact that multiple genes might be contributing to just certain small populations of autistic children. So

it is going to be very difficult to pin down a gene or genes for autism, although clearly there is a genetic basis.

91

But I focus most of my energy on treating people that currently

have autism. That has been emphasized today, not only the need

to find the cause but to treat those people we already have with

autism. I would like to see more funding put into treatment—not

just drug treatment, but other forms of treatment—for autism.

The question came up earlier—and Dr. Segal referred it to me— regarding adults with autism. When I began my work 12 years ago

at Yale University, at the time I was not a child psychiatrist. Due

to various factors, I was not allowed to see children—maybe for a

good reason. But I really wanted to study autism, so I initiated a

clinic for adults with autism, which was really unheard of at the

time.

My colleagues looked at me strangely and said, why would you

want to study adults with autism? I asked them what they thought

happened to children when they grew up. Most people view autism

as a childhood disorder. In fact, it is a childhood-onset disorder that

lasts forever.

Those individuals, in fact, are out there. One of my moonlighting

jobs while I was in Connecticut as a consultant to the Department

of Mental Health—and I actually went to the State hospital and

the ‘‘back wards’’ where adults were hospitalized, and not infrequently could I identify individuals that had a history consistent

with an earlier diagnosis of autism.

So they are out there, often misdiagnosed with schizophrenia or

other disorders. But I will say that since I have been in Indiana

and am now seeing kids, the ratio of kids coming to me versus

adults is highly skewed in the direction of newer onset of cases in

children. So the adults are out there, but there are many, many

more kids and younger individuals who are being referred at this

point. I have a sense that the numbers are increasing significantly.

Again, I do not know the reason for that.

Mr. BURTON. Can you sum up, Doctor, so we get to some questions in just a few minutes?

Dr. MCDOUGLE. Sure.

I have really touched on our clinical and research efforts. The

other thing I would like to highlight would be our efforts in education. That is something else that has been brought up today.

Pediatricians and family practitioners are not adequately educated about autism. I never heard about autism in medical school

at all and first learned of it during my second year of psychiatric

residency. So what we are doing within our clinic is having all the

medical students in fact rotate through our clinic with us so that—

we are the second largest medical school in the country—a large

number of students are at least now seeing individuals with autism

and being exposed to those treatments. I think that is important.

Mr. BURTON. Very good. I think we will come back and talk with

you. You are doing a good job there and I am happy to work with

you.

Dr. MCDOUGLE. Thank you.

Mr. BURTON. Dr. Wakefield.

Dr. WAKEFIELD. Thank you, Mr. Chairman. It is a great pleasure

to be back here and provide you with an update and recommendations following last year’s meeting.

[Slide presentation.]

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Dr. WAKEFIELD. Let me just give you my terms of reference, and

that is that we are dealing with a subset of children on the autistic

spectrum. What I am going to present to you is based upon the scientific data. It is not fragmented. It is based upon a logical, hypothesis-testing framework. It is not anti-vaccine. However, it is not

based upon assumptions of safety or coincidence. It is not an isolated opinion. It is the opinion of a growing number of physicians,

as you have heard today, and it is based on conventional methods

of listening to the patients and parents and the new-kid-on-theblock in this context is public health.

Let’s go to the clinical history, which I will just briefly review,

and that is of normal early development, of developmental regression, and the majority of parents cite the contemporaneous regression of their child following MMR vaccination. There is onset of associated neurological and gastrointestinal symptoms. The children

also suffer recurrent infections.

You have heard that bowel symptoms are common in autistic

spectrum disorder children, particularly in the United States, between 47 and 80 percent. So these findings may apply to a large

proportion of the pediatric population with autism. The GI system

are often masked by behavioral problems and if a history is not

taken by an expert in gastroenterology, then these can be missed.

The question for the physician is, do these symptoms in these

children reflect underlying intestinal disease? The medical profession hitherto have said, no, they do not. The answer is, yes, they

do.

We have now published several papers, peer-reviewed papers.

The first in the Lancet in 1988 and then in the American Journal

of Gastroenterology in 2000, which was met with a very favorable

commentary from the editor. And just a few weeks ago we published on the characteristics of this bowel disease in these children,

comparing it with classical inflammatory bowel diseases, Crohn’s

Disease and enterocolitis, and normal controls, peer-reviewed and

published data. We are presenting next week in Europe the discovery of not only a disease in the large intestine, but a disease in the

small intestine as well.

And you have heard a great deal about autoimmunity. The disease in the intestine of these children is an autoimmune disease.

There are antibodies in the blood of these children that bind to the

lining of the bowel and seem to be part of an inflammatory reaction.

The key features are of developmental regression, swelling of the

lymph glands in the bowel—this is consistent with a viral cause.

The enterocolitis and inflammation throughout the gut is consistent with a viral cause. And the immunodeficiency we see in these

children is consistent with a viral cause.

The important thing, though, Mr. Chairman, is that parents

were right. The medical profession was wrong.

This issue of coincidence—and this is an important one—a child

receives the MMR vaccine in the second year of life, and this is

when the first signs of autism are noted. Bear in mind that we are

dealing with regressive autism in these children, not of classical

autism where the child is not right from the beginning. But coincidence is a situation you arrive at by due scientific and clinical inVerDate 11-MAY-2000 09:23 Feb 22, 2002 Jkt 000000 PO 00000 Frm 00096 Fmt 6633 Sfmt 6633 C:\DOCS\76856.TXT HGOVREF1 PsN: HGOVREF1
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vestigation. It is not something that you assume from the outset.

That is not good medicine; it is not bad medicine; it is nothing at

all.

We will gain nothing from looking at children who had a single

dose. But can we gain something from looking at children who had

more than one dose? It is very important to raise this issue because

this came up at the Institute of Medicine’s review.

Here we have a group of children, each time line representing

one child, and these children received not one dose but two doses

of the MMR vaccine. What we see is that in many cases the red

square and circle represent their contemporaneous regression into

autism and subsequent deterioration. The green square and circle

represent their first and second exposures to the vaccine.

What we see in many of these children is a double-hit phenomenon. They regress after the first dose, and then they regress further after the second dose. Let me give you an example, that is the

child with the larger icons.

This child did not receive his first MMR vaccine until he was 4

years 3 months of age. This is not just recognition. He then deteriorated into autism. Clearly, this was not even autism by definition,

a disintegrative disorder. He then received his second dose at 9

years of age and disintegrated catastrophically. He became incontinent, his feces and urine, and he lost all his residual skills. This

is not coincidence.

The reason I am concerned about this, Mr. Chairman, is that at

the IOM’s review there was considerable concern and anxiety

raised over these double-hit issues, these double-hit cases. The data

were requested from me to be discussed in the closed session of the

IOM, such were the concerns of the committee members. However,

they find little or no mention whatsoever in the IOM’s report.

The IOM’s report gives one and a half pages coverage to Dr.

Fombonne, who was one of the co-presenters. It was sent to him

for review subsequently so that he could make amendments. It was

not sent to me. It was also sent for review—as you pointed out—

to people who have a clear conflict of interest in the vaccine arena.

The reason it was not sent to me, I am certain, Mr. Chairman,

is that these cases were not included. This analysis was not included. And that gives me great cause of concern.

Let me read you a comment from the IOM’s report. ‘‘However,

well-documented reports of similar outcomes in response to an initial exposure to a vaccine and a repeat exposure to the same vaccine, referred to as challenge-rechallenge, would constitute strong

evidence of an association.’’ When we look at those, you see them.

Those represent strong evidence of an association. They are well

worked-up and well-characterized cases.

So the question is, is the virus present in the diseased intestine?

These data were presented at the Cold Spring Harbor meeting earlier this year, and they were overseen by experts from the National

Institutes of Health.

Is the virus present in the gut? Yes, it is. The viral gene and the

protein are present.

Where is it located? It is located in the specific cells that we

would recognize if it were the cause of this disease.

How much is there? It is certainly a low-level infection.

94

Can we confirm the presence of the virus with different technologies? Yes. We have now applied 10 different technologies to

this.

Does the presence of the virus distinguish these children with

autism from controls? It is present in 93 percent of the children

with autism and 11 percent of controls.

And can it be confirmed in independent laboratories? Bearing in

mind that Professor O’Leary’s laboratory was completely independent from mine initially, these further studies are underway, and

the answer provisionally is yes.

The question we have now, Mr. Chairman, is, what is doing

there? We are not saying it is the cause of this regressive autism,

but the question is, what is it doing there? That is the next phase

of our logical progression.

What is the link between the gut and the brain? We do not know,

but it certainly is biologically plausible that one exists. It may be

that it is an autoimmune process shared by the gut and the brain,

or it may be that there are toxic contents of the gut that are getting through and hitting the brain in a situation similar to that

which we see in patients with chronic liver disease.

Here is a child whose only treatments have been to the gut. He

is an autistic child whose only treatments have been diet and control of his gastrointestinal inflammation. You can see that by solely

treating the gut there is a demonstrable improvement.

What about the shortcomings in epidemiology? In short, Mr.

Chairman, they have tested the wrong hypothesis. My colleagues

and I have not proposed any hypothesis thus far that can be tested

by epidemiology. We are still in the process of defining the parameters of this disease. In particular, we are concerned with what

makes a child potentially vulnerable to a subsequent adverse outcome to an MMR vaccine. What sets the child up to then respond

adversely to the vaccine?

What I have done is spent the last 3 years traveling the world

and interviewing patients in our own clinic to try and establish

from the clinical histories what those vulnerability factors might

be. When we look, we see that there is a strong family history of

autoimmune disease, particularly on the mother’s side—of diabetes,

thyroid disease, or Crohn’s Disease, for example—that the child receives the vaccine in the presence of an infection or in the presence

of recent or current antibiotic use, that the child has preexisting

allergies, particularly food and milk allergies, and that the child receives many vaccines at the same time.

These are consistent elements that have emerged in the clinical

histories that I now believe may represent vulnerability factors.

So let’s look at what the data show. The hypothesis that has

been tested and put down to me—which has nothing to do with me,

whatsoever—is that if this is related to MMR vaccine, then at the

point of introduction of the vaccine there should have been a stepup in the numbers that should have levelled out as the vaccine uptake was saturated.

Is that a reasonable hypothesis? Can we assume that the background susceptibility of the pediatric population has remained constant? No, I do not. I do not think we can do that. What we actually see is an increasing incidence.

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The time trend analysis for autism in the United Kingdom and

California have confirmed the rise. The data are entirely consistent

with an increasing vulnerability of infants to adverse reaction to an

MMR vaccine. They are certainly consistent with the clinical histories of affected children. And again, I am not saying that this in

any way proves causation. What I am saying is that we will gain

insight into this disease from taking appropriate clinical histories

and investigating and set up our epidemiologic hypothesis based

upon that. Now we have a hypothesis that can be tested.

So in conclusion, Mr. Chairman, there is a group of children

whose autism is associated with developmental regression,

immunological abnormalities, intestinal disease, persistence of

measles virus infection in the intestine, and onset following MMR

vaccination. What I would recommend is that there be a high-level

strategic meeting that is formed and a working group formed under

the American Gastroenterological Association to investigate this

specific group of children with the aim of providing appropriate and

necessary clinical care for these children.

That is an absolute priority. The medical profession has let them

down very, very badly thus far. And a research strategy needs to

be defined by this group in order to understand this disease.

There needs to be immediate institution of active surveillance for

vaccine-related adverse events. Passive surveillance has known to

have failed. I believe that monovalent vaccines should be made

available. This should be an issue of parental choice. I think it

should be a priority that we identify those vulnerability factors— for example, a child who might be on antibiotics—and exclude them

from vaccination until they have improved. We also need a policy

for identifying and protecting susceptible children, and most importantly thereafter, informed choice.

It is ultimately a pro-vaccine argument, Mr. Chairman. If we

have the ability with a single vaccine to prevent not only the acute

disease, but this concurrent exposure, then we have the ability to

protect children both against measles, mumps, rubella, and against

this devastating consequence.

Thank you.

[The prepared statement of Dr. Wakefield follows:]

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Mr. BURTON. Thank you, Dr. Wakefield.

Do we have your entire report?

Dr. WAKEFIELD. Yes, Mr. Chairman.

Mr. BURTON. We will submitting these reports to the health

agencies of this country and we will get a response from them after

they review the reports.

Dr. Spitzer.

Dr. SPITZER. Thank you, Mr. Chairman.

I would like to ask with respect that if I need to be cutoff—because there has been a lot of work done since I was here at this

committee last year—that I be allowed at least to share with you

what is in the future, the research that has been planned, some of

it that has been called for, and which is going to be undertaken by

an intercontinental group in nine countries and three continents to

deal with some of the issues because this is the first time it has

become public—and appropriately so—because 1 year ago, here in

this room, I decided to commit the rest of my epidemiologic career

to exploring these issues, if nothing else, out of admiration for the

families.

Mr. BURTON. We will allow you a little extra time. We have the

other speakers. Because of time constraints, we have a little bit of

a problem. But any additional information you have, you may rest

assured will be put in the record and we will pass it on.

Dr. SPITZER. I will go as quickly as possible, particularly on those

issues that are not specifically future-oriented.

The kind of research Dr. Wakefield does, with which I am familiar as much by the literature on an arms-length basis, is characteristic of laboratory and of clinical research which asks the

question, can it happen? Epidemiology asks the question, does it

happen? And then seeks answers in that direction.

The vast majority of the literature—and I have looked at pretty

much everything the IOM looked at in the last 15 months on epidemiology—is inconclusive or uninterpretable answers. We are trying

to remedy that, and I will explain why in questions or otherwise.

[Slide presentation.]

Dr. SPITZER. My perspectives are those of a professor of epidemiology and of public health medicine. I believe in immunization as

the pillar of public health, but this does not mean that each new

product can be exonerated from very careful evaluation, not just of

effectiveness but of safety.

I have no sponsorship. The first time I have had coverage of my

travel expenses was today. I work for no one. This is an initiative

done without sponsorship and as neutral as I think can be attained

normally. And I have no family members in the nuclear family or

extended family with autism. That is not the motivation for my involvement, although that is a noble involvement.

Autism is an outcome—with very great respect for parents and

families of children—that is as serious as death. It could not be less

significant if I were involved in a mortality study resulting from

MMR. The big differences are that the families of autistic children

cannot grieve. It is their love, their commitment, and their undying

optimism that masks the severity of autism. It is very important.

It is part of the reason I made a commitment to the strategy for

the future of autistic research.

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The Institute of Medicine in a sense agreed. It said the disorders

are incurable, permanent diseases that result in a serious developmental problem in children.

Incidentally, I was only able to get the executive summary. I

came from overseas last night to be here. Where I was, I could not

get the full report, so I can only quote the summary. If asked, I

shall do that later.

I decided, having finished a review of much of the literature and

the research literature on March 1st, approximately, when I submitted my paper to appear this month, that one has to really worry

about autism based on the epidemiologic literature. And I will summarize it quickly. There is no evidence epidemiologically one way

or the other that either rules in or rules out the problem.

A few days later, I was pleased to read the briefing document of

Dr. Soto and his colleagues to the Institute of Medicine Committee,

which reached pretty much the same conclusion—differences in

words and emphasis—but pretty much the same. You cannot rule

it in or rule it out.

Yesterday or the night before last, I saw that executive summary. You could interpret it the same way, but the wording and

emphasis and what got to the press—the public relations version,

if you wish—was that immunization is widely regarded as one of

the world’s most effective tools for protecting the public health and

the evidence favors rejection.

If they are 48–52 percent, I am 52–48 percent. It is in the other

direction. There has been no research that predicts the validity and

interpretation of Dr. Wakefield’s research, with which I have had

nothing to do so far. Until that is set aside, I could not make that

statement, although we are within percentage points, probably, of

the verdict looking at the same literature.

There is a great deal found in the report that alludes to causation. In biological population science, you have to demonstrate association before you get to causation. Normally, unless the results are

very dramatic, you have to invoke the laboratory and the clinical

science at the same time as the population science to reach those

kinds of conclusions following criteria such as the Bradford Hill criteria, much as the surgeon general did with smoking of cigarettes

30 years ago or so.

So we have not gotten to association yet. None of the studies

have gotten there, and certainly—say, the Taylor Study—cannot

refute or confirm association, certainly not causation. That study

mandated in the United Kingdom just does not prove anything. It

is a preparatory, preliminary, hypothesis-generating study, not a

hypothesis-testing study. And that is where we need to go.

These are the headings—I will go over them very quickly, Mr.

Chairman—the issue of the epidemic of autism, natural history of

autism—I will let you read them for a minute.

Speaking as an epidemiologist, there is an epidemic. It is not refutable on the evidence that is there. I am saying it, even though

the great majority—except for one or two studies—they are all

prevalence studies. A prevalence study is inexpensive and that is

why one leans in that direction with the meek resources that are

given for this kind of research. You need incidence to clearly demonstrate or refute an epidemic.

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And the one peer-reviewed published study that did incidence— which is a case study out of the Boston Collaborative Surveillance

Unit at Boston University, based on the British data base—it is an

incidence study and it shows an epidemic. It is a seven-fold increase.

In California, you reported yourself, Mr. Chairman, that there

are 700 new cases—which is incidence—in the past 3 months. Compared to the same seasonally adjusted period of 3 months 7 years

ago, that is a 404 percent increase. That is an epidemic.

In Ireland, just the day before yesterday, there is a three-fold increase in prevalence done in the last few months. And in Cambridge University, a study showed a 10-fold increase in prevalence.

These are numbers that are not the basis upon which you question

an epidemic. We have an epidemic of autism and I assert that, as

an epidemiologist, with confidence.

There is a widespread assumption that the autistic symptoms

typically do not emerge until the child’s second year, about the

same time that MMR is first administered, a sensible observation

made in the executive summary of the IOM. And you, Mr. Chairman, in your introductory comments asked for the science about all

this.

I have been working pro bono with the autistic families in the

United Kingdom, who are challenging Merck, Smith-Kline, and

others about the possible association. In documents I read of the

attorneys of those companies, the statement was that 55 cases of

autism were reported worldwide in the last 20 years of children

with autism.

But I said, wait a minute. There are 505 cases in this list here.

Where do they get that? Apparently, they are reported on the

wrong color of paper to the yellow card system, so it does not make

it into the official statistics.

So I decided that we should do an observational exercise—I barely call it a study—abstracting each of the medical records of these

children and having some summaries to help us understand what

is going on. We did it. I had an interdisciplinary team do this natural history of autism on a self-selected sample. I admit that. This

is not representative of anything. We did not even do statistical

tests for that reason.

The children had to be less than 15. They had to be free of symptoms not only before MMR but for the first 30 days after to bias

it against us. All symptoms, signs, and diagnosis had to be in writing by a health professional, not just casual reporting—which is

meaningful, but nevertheless difficult to validate.

We ended up with 493 medical records that could be used. I was

sort of sobered. I entered a room that was full floor to ceiling and

wall to wall with records. There was not enough space to work, but

we did it anyhow. The average width of a chart was three volumes

totaling more than 10 inches. That is what we were looking at.

This was looked at independently by the professor of family medicine of McGill, by a clinical psychologist from the University of

Glasgow, by myself as an epidemiologist, and we had research assistants helping us with the tasks. It was a descriptive analyses

only, as I said. I am reporting it for the first time. We met last Friday for the final analysis. We may end up by one-half percent beVerDate 11-MAY-2000 09:23 Feb 22, 2002 Jkt 000000 PO 00000 Frm 00134 Fmt 6633 Sfmt 6633 C:\DOCS\76856.TXT HGOVREF1 PsN: HGOVREF1
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cause I questioned three records, which are being checked on now.

That is what we were doing last Friday and we are writing the

paper now, which should be sent in a week or so.

So there you see 493 medical records. The numbers there for exclusion, the 372 eligible subjects—most of the ineligibility was that

they had symptoms early on and we wanted to bias it against us.

We had 70 percent of those cases as classic autism; 7 percent were

atypical autism; aspergoes were 8 percent. Of those cases, 40 percent were regressive, 40 percent were failure to develop, and 9 percent were both.

But most importantly—and that is with reference to the evidence

you were looking for—this is not good scientific evidence, but it is

a start—if you see there, the median years from receiving the first

dose to making the diagnosis was 2.6 years. That means that half

the cases were 2.6 and greater. And there was great variation.

If you look at average, which is a bit higher, it is 3.2. But the

median is more accurate because of the distribution. And the range

is from 0.5 to 11.9 years of delay. The correlation does not even

exist, the date of vaccination and the onset of this category of diseases.

I would just like to allude to this, Mr. Chairman. I have been

looking for 17 months for studies with scientific admissibility that

are adequate pharmacological-epidemiologic evidence of safety,

which you would need when a concern has arisen in the community

about safety of a particular drug. I have not found any. I have not

found it. A proper study of safety under the current conditions,

given the frequency of the disorder, would require about 450,000

children. I went through that with statisticians at Cambridge. And

that has never been done.

And the ‘‘safety studies’’ published are of scores of patients. That

is a type of sample size which is simply inappropriate, insufficient,

and not a scientific way to look at the safety of a drug. I am astonished that the authorities in the United Kingdom, the United

States, and my country of Canada are not requiring it the same

way they have required us to do it for all contraceptives, for the

right reasons.

The problem is incorrect length of followup as much as anything

in these cases. For instance, the Medical Research Council report

widely cited in the United Kingdom as setting aside the concern

followed an unrepresentative subsample of the sample of children

I looked at for 3 to 6 weeks when the range is from 0.5 years to

11.8 years. The study is simply not valid for that reason alone and

cannot be invoked to demonstrate safety or the lack of a need for

concern.

There is no problem if you do not look. The companies know that.

Those of an opinion that there is no association say that epidemiologists have shown no evidence. Of course, they have. And

they have all been small studies. I call them phyto studies to my

students. Phyto means arenal products in the ocean. It doesn’t

make any difference in the levels in your understanding.

Nobody has looked. And the cost of looking is that of millions of

dollars. Is that OK? Yes, it is OK. Look at the millions of dollars

of profits. One way of pretending you are looking but not looking

is by under-powering the studies. They are not powered sufficiently

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high to be able to deal with the no-difference issue leading you potentially to what we call a type two error statistically.

I will just tell you—and it is in the written record—the Finnish

study reported widely by the press in Britain—much like likely the

IOM reports will be somewhat misrepresented—does not in any

way demonstrate safety or lack of it because it is a passive surveillance study designed for other purposes and then reanalyzed for

another reason. I give a page and a half of reasons why that study

just does not mean anything one way or the other. It is in the written record, Mr. Chairman.

Research priorities—I will list them quickly and I will end up

with the study.

Ongoing research in laboratory and the clinic—I will not say any

more. A lot has been said about treatment, but I would add a word

that I hardly ever hear and that is about palliation. The families

need treatment as much as the children, and palliative strategies

need to be undertaken. I am sure my clinical colleagues couldn’t

agree more with that. But it does not get priority in potential focus

of support.

Correctly designed safety studies. Correctly designed incidence

studies. And case-controlled studies.

This past Saturday and Sunday, we met at Heathrow Airport,

representatives from six countries out of nine possible candidates,

to decide go/no-go on a major intercontinental study. The IOM said

the committee does propose targeted research efforts and more rigorous data-gathering procedures. Much of the problem in existing

research is that you are going into data that were created for a

purpose other than exploring that hypothesis. That is a lot of the

problem. This is going to get around that.

Mr. BURTON. Doctor, are you about to wrap up?

Dr. SPITZER. I need 3 more minutes, or less, if I can.

We reached a ‘‘go’’ decision on Sunday, a few days ago. We have

been working on it since. I am going back to it.

We are going to explore risk factors other than MMR as well because there is no point going in 5 years and then deciding that we

should have looked at something else. We are going to try to avoid

that.

The candidate countries are on the slide, nine countries. Why so

many countries?

In England, Canada, Denmark, and the United States there is

such an overwhelming coverage that obtaining control is almost impossible. You have to have control. The contestants of clinical

science and epidemiology and laboratory science as well is comparison. Without comparison, you have generation of hypothesis in the

main, very seldom testing of a hypothesis.

You ask in epidemiology, how is your spouse? And you will probably hear something like, compared to whom? [Laughter.]

You have to have comparison, and that is why we are proposing

a case-controlled study, and to do much of it in-country. Poland

only has 35 percent coverage today. The rest is univalent. The

same with Argentina and the same with France.

Selected features of the study—quickly—3,500 cases and 7,000

unaffected controls. Exposure risk factors: MMR, mercury, other

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tive but as examples. The outcome is the entire spectrum of autistic disorders.

Why 3,500 cases? Because, as has been said by many already— and I am pleasantly surprised—we will likely find the problem in

a subset. It is a multifactorial problem, almost certainly everyone

seems to agree. But we do not know what that subset is in advance.

I would propose that a subset of less than 10 percent—it is either

not discoverable or not as important. So we are making 10 percent

the threshold. That gives you 350 cases and the corresponding control that may give us important answers.

Finally, it is investigator-initiated. We are not responding to any

request for proposal, therefore we have to create the protocol and

then ‘‘sell it’’ to objective, independent organizations. The cost is es- timated to be $17 million to $21 million over 5 years, $125,000 in

the first year.

Is that a lot? It is the equivalent to the annual cost of care and

support of 0.3 percent of autistic children in the United States

alone. We have only methodological support from the United States

so far. We have support from most of the other countries. We will

do it. We would like to work with the United States. We do not

need the United States or the United Kingdom, for that matter. We

hope we can push ahead with this and look for some of the answers

that are being called for.

I apologize for the delay. Thank you for your attention.

Mr. BURTON. Thank you, Dr. Spitzer. We will take your whole

program and submit that, along with the others, to HHS and ask

them to take a hard look at that.

Dr. Haley.

Dr. HALEY. I am probably one of the few people here who does

not treat patients. I am a research scientist and I work in a lab.

I was asked some time ago to look and go to the bottom line. Are

the vaccine mixtures that we are placing in the children toxic? If

they are going to have an effect on autism or any disease or any

neurological disorder, there is a good possibility, if it comes from

the chemical level, that vaccines have to show some toxicity at the

molecular level.

We did test vaccines, and I will make this very short because I

know we are in a hurry.

We compared the vaccines with and without thimerosal from the

same source, the same type of vaccine, and those with thimerosal

present were remarkably much more toxic—over 10-fold to 100-fold

more toxic than those without thimerosal. There was one outstanding exception, and that was the MMR vaccine. The MMR vaccine

was as toxic as the vaccines with thimerosal, but there is no thimerosal in the MMR. We measured mercury levels, and I think the

thimerosal is not there, but we would want to do a lot more numbers of vaccines.

But there is something in the MMR vaccine that does inhibit the

enzymes and the brain protein systems that we have very dramatically. I do not know what it is.

I would point out also that the toxicity is thimerosal in a vaccine

mixture. In our studies, we looked at combined toxicities because

we are not rats living in a pristine cage. Aluminum is a neurotoxin,

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formaldehyde is neurotoxic, and you throw that in with thimerosal,

which breaks down to ethyl mercury, a well-known toxin. You do

not know what you will get without doing studies. I have looked

hard and cannot find them. I am surprised they were not done, but

not totally. This is just something we do not know the answer to.

We do know that ethyl mercury is very, very toxic. Of the studies

you can read about, of the three children that have been intoxicated that I have found—they all died with 1 microgram per ml

levels. That is considerably below what they would do, but you just

do not hit a point and then die. You start a linear progression of

health effects.

The other thing, when we talk about the level of mercury that

is toxic, you cannot compare mercury to ethyl mercury to dimethyl

mercury. They are different compounds. Ethyl mercury, methyl

mercury, and especially dimethyl mercury are much more toxic

than an equivalent amount of mercury on the atom or mole basis.

So you cannot compare them.

I would also point out that the reason mercury does not kill us

immediately is that a lot of it depends on our health. We all live

at a level where we have reducing equivalents this high when we

are 20 years old. We are full of spit and vinegar. And the mercury

level is down here and we are handling it real well. As we age, the

level of glutathione, metallothione, and other proteins that we synthesize in our bodies—because the energy level drops down—gets

to the point where we are getting more balanced. When we get too

old or too unhealthy, then we pass this. Then the mercury can take

over and start having the effect of damaging the healthy proteins,

the proteins we really need in the body.

I would also point out that this level can drop precipitously if you

have a viral, bacterial, or fungal infection. It will drop dramatically

because it is fighting to take care of the oxidants because the molecule that removes mercury from our body is also the molecule that

takes care of the reactive oxygen species, the normal aging products, and the materials we call oxidating stress products.

I am surprised, when I understand the data that they are presenting here—we know certain children are born that are autistic.

These vaccines need to be cleaned up because even if they did not

cause it, who would want to give ethyl mercury to a child that is

destined to get autism? It is a very poor idea. You really need to

clean the vaccines up. I cannot imagine why they did not take the

vaccine mixture and test it, on the very base level in a test tube

against a bank of enzymes or against a brain homogenate to see

whether or not they were injecting toxicants into these children. It

is very clear that has happened.

I would also point out that we have a problem with combined

toxicities. People that smoke are heavy in cadmium. And cadmium

and mercury, if you combine them together in a test tube and test

system against tubulin—which is probably the first protein affected

in Alzheimer’s Disease—that you can have a non-toxic level of mercury, a non-toxic level of cadmium, and you add those two together

and you will get over 50 to 60 percent toxicity on a comparative

basis.

Combined toxicities and the multiplicity of the events that are

caused by mercury—mercury is somewhat similar to alcohol in that

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when different people get exposed to it they behave differently—so

it is very difficult when you want to look just at someone who is

an autistic. To me, that is a name and it is a tantology. Autistics

do this. And yet, I say, do all autistics do that? No. Then there is

a difference. They are not the same. You have to look at them differently. So we have a very confused issue here that I think we

need to look at.

I would also point out that in the vaccine issued, the one thing

that really makes the vaccines toxic to infants—you are giving the

same shot to an infant that you give to a 180-pound soldier. Infants

do not have bilary transport. They do not make bile when they are

first born and for some time after that. The bilary transport system

is how the body removes mercury from the system. Babies cannot

do that. So it is the equivalent of drinking alcohol and not being

able to metabolize it. It builds up. It would stay there and be much

more damaging to an infant than to someone who is an adult who

had the ability to rid the body of the mercury.

Aluminum is removed by the renal system. Infants have an immature renal system. They cannot handle heavy metals and get rid

of them as fast as we can. If you give them multiple shots with

high levels of mercury, I do not know how well they handle it. I

have not been able to find any data where this has been tested. So

the mercury and aluminum levels would buildup in these infants

if they had multiple shots before they got to the point where their

bilary and renal systems were totally mature.

The aspect of genetic factors—I was in New Zealand I talked to

a doctor by the name of Mike Godfrey. He is a friend of mine and

he and I have talked a lot about Alzheimer’s Disease and the involvement of mercury. Johns Hopkins University showed several

years ago that there is a risk factor, a gene called APO-E protein.

There are three copies, two, three, and four. Two is protective

against Alzheimer’s Disease; four puts you at high risk for the disease.

If you look at the chemistry of the APO-E proteins, this can be

reflected in the fact that it is a housekeeping protein that clears

the brain of waste materials. If you have APO-E2, you can carry

out two atoms of mercury for every atom of APO-E that goes out.

If you have APO-E4, you can carry out none.

He took this and looked at autistic children. When he did the

screen of autistic children, there was a huge preponderance of them

that had APO-E4, indicating that there is a genetic risk factor

which deserves further study. And it does implicate that the inability to detoxify the cerebral spinal fluid may be at least part of the

neurological aspect of this disease. I am not a physician, so I do

not go there to make answers about that.

I have also been in a fight with the pro-dental amalgam people

for many years, as I did research about 10 years showing that mercury dramatically inhibited the same enzymes that are dramatically inhibited in an AD brain. And everyone says there is not

enough mercury there to do it. Recently—and it is in the report I

did—they have found that studies using neurons and culture, that

levels of mercury approximately 100 to 1,000-fold less than you

have in your brain, when you place it with neurons in culture will

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cause the formation of the two diagnostic hallmarks of Alzheimer’s

Disease.

I went to NIH and screened the grants they fund. We found one

where they are funding the ability to make a better amalgam that

would leave less mercury because there was some concern about

the mercury being released, which, according to the ADA is a totally safe level. But there are no grants looking at the effects of

low-level mercury exposures to Americans. But we are placing

grams in our mouth and micro grams in our vaccinations.

I cannot say, nor would I say, that vaccinations cause autism.

However, if the data holds up that I have been seeing with the relationship, I think it is an awfully good suspect, at least one of the

co-factors that might aid in the onset of this disease. So I would

really recommend and encourage you to put some pressure on NIH

to look at the contribution of different forms of mercury we put in

our medicines and in our dentistry to see what effect they have on

the neurological health of Americans, especially autistics.

Thank you.

[The prepared statement of Dr. Haley follows:]

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Mr. BURTON. Thank you, Dr. Haley.

You may rest assured that we are going to put as much information before them and—if you want to call it pressure—pressure

them as much as possible to research all of this.

Dr. Amaral.

Dr. AMARAL. Mr. Chairman and members, my name is David

Amaral and I am a professor of psychiatry and neuroscience at the

University of California, Davis.

The last 3 years, it has been my great privilege to be the research director of a new clinical research experiment called the

MIND Institute. MIND stands for Medical Investigation of

Neurodevelopmental Disorders. I deliberately referred to the Institute as an experiment because of the unique way in which it came

into being, the unique way in which it governs its research, clinical,

and educational programs, and the unique focus on understanding

the biological basis of autism and other neurodevelopmental disorders in order to discover treatments and ultimately cures.

Historically, parents of children with autism have been given little hope and frequently advised to institutionalize their child and

move on with their lives. This option was unacceptable to four Sacramento-area fathers, all of whom had sons diagnosed with autism

in the 1990’s. Chuck Gardner, a general contractor, Rick Hayes, an

investment management, Rick Rollens, former secretary of the

California State Senate, and Lou Vismara, a cardiologist, joined

forces to create the concept of developing a world-class research

and treatment center devoted to understanding the biology of autism in order to find treatments for theirs and other’s children.

These four dads approached the UC Davis health system with

the idea of forging a unique partnership between a University medical center and parents of autistic children to develop an institute

where families could bring their children for state-of-the-art onestop diagnosis. Those children diagnosed with autism or other

neurodevelopmental disorders would then become subjects for multidisciplinary research aimed at understanding the causes and

medical ramifications of their disorders. Once the biology of autism

was better understood, then the clinic would become the proving

ground for new treatments that would be developed based on the

new research findings.

The MIND Institute research program, since that time, has followed a number of parallel paths of development. It is important

to point out that the Research Committee, which is charged with

all decisions about research direction at the Institute, is made up

equally of parents and senior scientists at UC Davis. The committee has agreed that the prime directives of MIND Institute research are to remain open to all possibilities of causality, to carry

out rigorous research in a collaborative multi-disciplinary fashion,

to carry out innovative and even highly risky research if there are

potentially large payoffs, and to try and determine the critical path

to understanding the biology of autism in order to develop treatments as quickly as possible.

The MIND Institute research program currently has four components. It has a UC Davis intermural program, and we are attempting to develop a critical mass of researchers and facilities at UC

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Davis in order to carry out state-of-the-art multi-disciplinary research on autism and other neurodevelopmental disorders.

It is clear that certain forms of research and therapy will only

be accomplished when an intimate relationship is established between the clinic and basic science. This is really the guiding vision

of the MIND Institute.

We have an investigator-initiated grant program. It is important

to note that more than half of all the research funds allocated to

the MIND Institute have actually been distributed to researchers

at other UC campuses and other research facilities internationally

to carry out research on autism and neurodevelopmental disorders.

This extramural program is guided, again, by the parent-oriented

philosophy that it is more important to get the critical research accomplished quickly than get the credit for accomplishing it at a

particular institution.

We also have targeted research initiatives. Funds have been allocated to carry out research in areas that are currently underrepresented or in need of immediate attention. The MIND Institute,

for example, has launched a nationwide effort to investigate the potential relationship between vaccines and autism. I will say more

about that in a moment.

Finally, we have a MIND Institute scholars program. A major

impediment—and we have heard this today—to rapid progress to

research on autism is the relatively small number of scientists and

clinicians who have autism as their primary area of interest. To encourage young scientists to enter the field, the MIND Institute has

funded pre-doctoral students and post-doctoral fellows throughout

the University of California system. It is hoped that these MIND

Institute scholars will be the future leaders of autism research.

Let me briefly highlight some areas of current and future MIND

Institute research. The first I would like to mention is the biomarkers program.

One of the first grants funded by the MIND Institute was awarded to a team from the California Birth Defects Monitoring Program, who collaborated with Dr. Karen Nelson from the NIH and

with investigators from the MIND Institute. We heard a little bit

about this this morning.

The so-called blood spot study sampled the blood spots that are

taken from all children born in California. The investigators sought

to determine whether there might be abnormal levels of certain

peptides in the blood spots of children who were later diagnosed

with autism.

This highly risky—what some would call a fishing expedition—

made the striking discovery that several peptides were elevated in

children who later became autistic or mentally retarded, but were

not elevated in children with cerebral palsy or normal control subjects. This has led to the suspicion that more sophisticated techniques might provide a diagnostic marker for those children who

are susceptible to autism. Of course, the significance of this finding

is that there is substantial suspicion that while autism has a genetic component which makes children susceptible to the disorder,

they must encounter another factor—a so-called second hit—that

brings on the autistic symptomatology.

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While it is not clear what the second hit may be—we have heard

that many parents and others are concerned that it might be childhood vaccination or environmental contaminants—regardless of the

precise identity of the second hit, if susceptible children could be

detected at birth or before, once the causative agents are determined, these children could be protected from exposure. Therefore,

finding a biomarker of autism is the highest priority of the MIND

Institute research program.

One strategy is to employ the power of the Human Genome

Project. In January 2001, the MIND Institute announced that it

was allocating $1 million to develop a new neurodevelopmental

genomics laboratory. The laboratory aims to identify a genetic profile or fingerprint of those children who may be vulnerable to autism. The goal of this program is to have an accurate diagnostic

test that will be used to evaluate all children at birth, like the children are currently tested for Phenylketonuria.

A second initiative has been our vaccine-autism link research. As

initially described by Mr. Rick Rollens in testimony to this committee on August 3, 1999—and we have heard much about this

today—there is strong suspicion among parents that one ideology

of autism of a child is associated with child vaccinations. While

many organizations have been hesitant to take on this issue, the

MIND Institute considered this to be a fundamental area for immediate action. If there is an identifiable culprit in existing vaccines

that cause autism, then the removal of the agent or changes in vaccination policy could reduce future cases of autism.

In August 2000, the MIND Institute issued a request for proposal for research leading to precise scientific data on the potential

links between vaccines and autism. With a private donation of $1.2

million and additional funds from the State of California, the RFP

was advertised nationally and throughout the UC system and several grants have already been funded to carry on this research.

Another area of research is on the epidemiology of autism. The

California State Legislature commissioned the UC Davis MIND Institute to carry out an evaluation of the factors that have led to the

nearly 300 percent increase in the number of clients with autism

in the regional center system and allocated $1 million for this effort. The principal investigator of this study is Dr. Robert Byrd in

our Department of Pediatrics.

The overarching goal of this study is to determine whether factors such as in-migration or diagnostic shift can account for some

of the increase in clients with autism. If you can discount some of

these factors, then it has to be something else and we will look at

those factors as well. The study team has been assembled. The

field work is planned for September through December of this year.

The analysis and reporting of results are slated for June 2002.

Another important area of work is what we call the autism tissue

program. Much of the progress that has been made in the understanding of Alzheimer’s Disease has come from the

neuropathological and molecular biological analysis of post-mortem

brain tissue. Literally hundreds of thousands of brains have been

evaluated through recruitment at Alzheimer’s research centers

throughout the United States. In contrast, fewer than 40 autistic

brains have been subjected to post-mortem analysis.

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While it is clearly a very difficult issue that requires utmost sensitivity and compassion, progress in the understanding of the biology of autism will rely on the acquisition of well-preserved brain

tissue from autistic patients. So to facilitate the goal of acquiring

and distributing this resource, the MIND Institute has joined

forces with the autism tissue program, sponsored by the National

Alliance for Autism Research and Autism Society of America Foundation, to carry out the nationwide campaign to make parents and

families aware of the need for tissue donations and to develop an

efficient acquisition network that will allow optimal use of this precious resource.

And the last area I wanted to mention is a recently announced

international meeting for autism research. There is currently no

national or international meeting that brings together all scientists

carrying out research in autism. The MIND Institute has joined

with Cure Autism Now and the National Alliance for Autism Research to launch the first international meeting for autism research

in San Diego on November 9 and 10 of this year. This meeting will

encourage presentations of all types of research dealing with any

aspect of biological basis of autism or experimental approaches to

treatment.

It is expected that this meeting will contribute to increasing the

awareness of new research findings and should foster new areas of

research as well as new collaborative efforts.

So to summarize, the MIND Institute has quickly established a

multi-component research program that is designed not only to

help the children of today but those of the future. First, we are

building a strong local infrastructure that will be uniquely capable

of carrying out translational research on autism. Patients will not

only be diagnosed in the clinic, but will become subjects for research. Once new findings lead to new treatments, the clinic will

be the proving ground for these approaches. And once a new treatment is proven, it will be distributed to institutions worldwide for

implementation.

Second, at the same time as research is carried out in Sacramento, the MIND Institute will support innovative research

throughout California and eventually, with adequate fundraising,

throughout the world.

Third, in addition to our own efforts, we will partner with other

advocacy and research groups, including the NIH, to foster efforts

that must be carried out through a concerted effort.

Through building a strong research team and collaborating nationally and internationally, it is my hope that we will ultimately

understand and defeat autism. In the meantime, the MIND Institute will do everything in our power to treat children who are currently afflicted and strive to prevent new cases in the future.

Thank you very much.

[The prepared statement of Dr. Amaral follows:]

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Mr. BURTON. Thank you, Dr. Amaral.

Dr. Miller.

Dr. MILLER. Thank you, Mr. Chairman.

Thank you for inviting me to this congressional hearing. I do so

in my capacity as an epidemiologist who has worked for 22 years

in the Public Health Laboratory Service in the United Kingdom on

vaccine-related issues, with specific expertise in studies relating to

vaccine safety.

For clarification, I should say that the PHLS in a non-governmental public body whose role is to provide a national capability

for the diagnosis, surveillance, and prevention of communicable disease and the provision of independent advice about the control of

communicable disease to help professionals and the Department of

Health. The remit of the Immunization Division—which is part of

the PHLS—of which I am head, is the national surveillance of immunization programs, including the safety and efficacy of vaccines

that are in routine use.

Together with statistical colleagues in the PHLS and other academic institutions, over the years I have conducted a number of epidemiological studies designed to investigate various putative adverse events after different vaccines, including MMR, DPT, and

more recently oral polio virus vaccine. These are referenced in my

CV.

In some of these studies, evidence of a causal link between a specific adverse event and a vaccine has been found, and risks as rare

as 1 in 10,000, 1 in 22,000, and even 1 in 143,000 doses have been

detected. In other studies of possible adverse events, the results

have been entirely negative. This is the case with the epidemiological studies I have conducted related to the postulated link between

MMR and autism. Similar negative findings have been found in

other work conducted elsewhere on the potential epidemiological

link between MMR and autism.

These epidemiological studies have been designed to test the

hypotheses implicit in the case reports and population trends in autism that Wakefield and others have interpreted as evidence of a

causal link with MMR vaccine. The published evidence cited—some

parents of autistic children say that the onset of symptoms in their

child first occurred shortly after MMR, that prior to MMR their

child was developing normally, that the onset of behavioral regression associated with MMR is typically accompanying by bowel

symptoms, and that there has been an epidemic increase in the

prevalence of autism which coincides with the introduction of MMR

vaccine.

The studies I shall describe have been designed specifically to

test the hypotheses that are implicit in these observations. I think

it is disingenuous of Dr. Wakefield to say that he has inferred no

hypotheses. I think it is also disingenuous of Dr. Spitzer to say that

the study I was involved with was essentially a hypothesis-generating study. It was specifically testing a prior hypothesis that was derived from Wakefield’s paper in the Lancet where the evidence that

is put forward for an association between MMR and autism is the

onset of regressive features or other behavioral disturbance shortly

after MMR.

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In brief, the summary of the findings of the various epidemiological studies—which are described in detail in my written submission to this committee with full references—are as follows.

There is no evidence that the onset of autistic symptoms is more

likely shortly after MMR vaccine than at any other time. Indeed,

new evidence which is shortly to appear from my colleagues and

myself in a vaccine journal shows that there is no evidence that

MMR vaccine increases the likelihood of autism at any time after

vaccination.

Children with autism are no more likely to have received MMR

vaccine than normal children. The introduction of MMR as a routine immunization for children in the second year of life has not

been associated with a step-up increase in the incidence of autism.

When analyzed by birth cohort, there is no correlation between

MMR uptake and prevalence of autism. I recognize that the Wakefield hypothesis has now moved on and has evolved—possibly

under pressure of these epidemiological findings—but it is important to remember that the published work of Wakefield and others

in relation to the putative link has been tested in the studies I

have just described the findings of.

Most importantly, the final finding I will describe and show you

the data from the study which is not yet published, there is no epidemiological evidence to suggest the emergence of a new syndrome

of autistic enterocolitis associated with the use of MMR vaccine.

As I said, this latest finding, which I think is most pertinent here

in relation to the postulated existence of this characteristic regressive autism with autistic enterocolitis—I would like to present the

results of this later study here.

If it is true that vaccine-attributable cases typically present with

developmental regression and bowel symptoms, then the proportion

of such cases should have increased since the introduction of MMR.

That is a logical conclusion and a logical inference from the hypothesis that is implicit in the data Dr. Wakefield has shown.

To test this hypothesis, my colleagues and I have updated our

1998 study of prevalent autistic cases in the North Thames Region

of England by carrying out a further survey in 2000, 21⁄2 years

later. The prevalence data of the more recent birth cohorts shows

that the rise in the early 1980’s and early 1990’s has now levelled

off with no significant increase in prevalence in birth cohorts from

1993 onward.

The current prevalence rate is about 1 in 350 to 1 in 400 children. That is a high rate. And I would like to make it clear at this

point that I do not in any way believe that this is a condition which

should not attract substantial amounts of funding. We need to find

the etiology and we need to find effective treatments.

However, the question of whether there has been an epidemic increase or whether that prevalence was there all the time but has

only been recognized with appropriate diagnosis and referral mechanism I think is open to question. Certainly, my colleague, Professor Brent Taylor, who is a consultant community pediatrician, is of

the opinion that the rise we had seen prior to 1993 was due to improve recognition and referral of cases rather than a real rise. I

think the fact that it has flattened off since 1993 is consistent with

that interpretation of the data.

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However, the main purpose of this updated study was to test

whether there has been an increase in the proportion of cases with

regressive features and bowel symptoms associated with MMR.

[Slide presentation.]

Dr. MILLER. This shows that amongst children—there were 500

children in this survey—of children with regression—we concentrated specifically on children with regression and bowel symptoms. You can see there the portion of children with regression categorized by whether they had ever had MMR or indeed any measles-containing vaccine, whether they had that vaccine prior to parental concern—those are the cases that could possibly be caused

by the vaccine, they were normal until they had thee vaccine—or

whether they had the vaccine after parental concern. You can see

that there is no significant difference in the percentage of cases

with regression by MMR status.

A similar analysis done of the percentage of cases with bowel

symptoms by MMR status again shows no significant difference between those three categories of autistic children—no MMR, MMR

before onset, or MMR after onset.

Looked at another way, if we look at the percentage of cases with

regression by year of birth, going from 1979 up to 1998—and remember that we introduced MMR in the UK in 1998, so in the

middle there—you can see there has been no change in the proportion of cases with regression by year of birth.

Similarly, there has been no change in the cases of bowel symptoms by year of birth. Neither did we find that there was any characteristic bowel features in association with the use of MMR vaccine, constipation and diarrhea. These results are currently being

submitted for publication.

In conclusion, in my view, the available epidemiological evidence,

both from the United Kingdom and elsewhere, does not support a

link between MMR and autism of the nature and frequency implicitly postulated by Wakefield and others and the basis of their published work so far. I recognize that the hypothesis has now evolved

and moved on. Indeed, it provides strong grounds for rejection of

the hypothesis that MMR is responsible for the reported rise in autism and that such cases are characterized by behavioral regression

accompanied by bowel symptoms.

Clearly, no epidemiological study could prove that MMR vaccine

never causes autism, however rarely. In this regard, epidemiologists are no different from any other scientist in that proof of a

negative is impossible.

As with all epidemiological studies of any putative adverse event,

the existence of a rare, idiosyncratic causal association cannot be

entirely excluded. However, the existence of such a putative association between MMR vaccine and autism is at present entirely

speculative.

Thank you.

[The prepared statement of Dr. Miller follows:]

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Mr. BURTON. Thank you, Dr. Miller.

Dr. Gershon.

Dr. GERSHON. Thank you, Mr. Chairman.

I am Dr. Michael Gershon, professor of anatomy and cell biology

at Columbia University in New York.

Life is often unfair. The unfairness of the life dealt to autistic

children, however, is so unfair that it defies comprehension. The

mental elements of autism, which may sentence an innocent child

to a life in virtual solitary confinement, are bad enough. To have

to endure that sentence in gastrointestinal misery outdoes the

trials of Job. The withdrawal from social contact that characterizes

autism is so striking, moreover, that the abnormal behavior of afflicted children has historically tended to blind non-parental observers to symptoms from their gut, which in comparison, seem

trivial.

Historically also, the possibility that there might be a

pathophysiological link between the gut and the brain has not been

considered, even by scientists who should have known enough to do

so. Help to alleviate the gastrointestinal accompaniments of autism, therefore, has only recently been sought and investigation of

the involvement of the bowel in autism begun.

Given that the involvement of the bowel in autism has not previously been studied, there is little that one can say right now

about the causes of that involvement except that it is a topic worth

considering. Certainly, the incidence of gastrointestinal problems in

children with autism appears to be high and if one really looks for

these conditions even higher. Professors Wakefield, Horvath, and

their colleagues, therefore, have done a real service for patients

and the biomedical community in publicizing the association of gastrointestinal abnormalities in autism.

At the start of a new field of research, such as the role of the

gut in autism, one naturally formulates hypotheses that one can

test. Hypotheses are very much a part of the scientific method. Unfortunately, it is relatively easy to construct an argument in support of a favored hypothesis, but an argument differs from evidence

and should not be confused with it. An argument can serve to motivate hypothesis testing, but evidence is required for hypothesis confirmation.

The hypothesis that MMR vaccine is a cause of autism is supported at the moment by a well-crafted argument. There is, however, little or no hard evidence available to support that hypothesis. Furthermore, based on my understanding of gastrointestinal

function and the nature of the blood brain barrier, I believe that

it is unlikely that the hypothesis, as originally formulated by

Wakefield and others, that MMR causes autism is correct.

The hypothesis that MMR is causally related to autism, which

has been associated with Dr. Wakefield, postulates that the attenuated measles virus component of the vaccine persists in the bowel

of those vaccine recipients destined to manifest autism as a result

of their vaccination. The persistent measles virus is thought to elicit an immune response that is then postulated to increase the permeability of the intestinal epithelium, giving rise to a ‘‘leak.’’

This leak enables toxic materials—in particular, opioid

peptides—to be absorbed from the intestinal lumen. These toxins

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then enter the bloodstream and are carried to the developing brain.

The so-called rogue peptides, which are derived from the gut, cross

the blood-brain barrier and damage the developing brain, giving

rise to autism.

The evidence that measles virus actually persists in the bowel is

controversial. The idea that measles virus persists has been recently been supported by Drs. Wakefield and his collaborator, Dr.

O’Leary, with data derived from sensitive molecular biological techniques, which suggest that the virus is present in the bowel, but

in very low copy numbers.

These data are still largely unpublished, and the findings have

not yet, to my knowledge, appeared in a peer-reviewed journal.

Other investigators have not been able to reproduce the molecular

observations. Furthermore, test samples containing coded amount

of measles RNA from cultured cells and from transgenic mice— which express the human measles virus—that were sent to Dr.

O’Leary by Dr. Michael Oldstone were not read with the effectiveness needed to support the claims of low copy numbers of virus persisting in the gut of vaccinated individuals with autism.

Oldstone has concluded that the record of performance would not

be acceptable for certifying a clinical laboratory. The virological

support for the hypothesis of measles virus persistence, therefore,

is not established and cannot be considered so until it is independently confirmed.

The data supporting the next step—the leak of toxic opioid

peptides into the body from the lumen of the bowel—is scanty at

best. Urinary observations of such are unreliable.

The thought that inflammation damages the epithelial lining of

the bowel, causing its permeability to increase, is plausible. On the

other hand, there is no reason that a leak in the gut should be a

one-way leak. Nor is there any explanation as to how a leak could

be specific so as to let only some molecules through and not others

of the same size and shape pass through.

No movement of peptides or proteins from the tissue fluid to the

intestine has been detected in autism or as a result of MMR vaccination. Protein-losing enteropathy has not been reported to be associated with autism, nor has it been reported to be a sequela of

MMR vaccination in any significant number of people.

On the other hand, if the bowel were to be permeable in a size

manner so that the large molecules of the body do not get out, then

small molecules from the gut would go both ways through the proposed hole. That would cause massive malnutrition and malabsorption in the patients, which has not been reported.

So the absence of a telltale protein-losing loss or a failure of absorption in patients en masse with autism and in recipients of

MMR vaccine thus suggests that the postulated leak of the gut admitting opioid peptides does not indeed occur. To paraphrase Sir

Arthur Conan Doyle in Sherlock Holmes, the failure of these things

to occur and the failure of absorption is the dog that did not bark.

The postulated leak of the bowel is thus unlikely to occur or to be

significant.

The idea that opioid peptides or other toxins enter the body from

the bowel and cause autism overlooks another filter that is in place

to remove them, and that filter is the liver. Everything the gut abVerDate 11-MAY-2000 09:23 Feb 22, 2002 Jkt 000000 PO 00000 Frm 00179 Fmt 6633 Sfmt 6633 C:\DOCS\76856.TXT HGOVREF1 PsN: HGOVREF1
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sorbs goes first to the liver as a consequence of the circulation.

There is no evidence that MMR damages the liver. The postulated

opioid peptides, therefore, would have to be absorbed in overwhelming amounts to overcome the ability of the liver to remove

them. The liver is exceedingly good at removing opioids. There is

no other toxicity noted in organs and the fact that the liver is there

and is normal in patients with autism suggests that this postulated

barrier is not overcome.

Finally, once the presumptively toxic peptides—if they ever

could—overcome the barriers of the intestinal epithelium and the

liver, which does not seem likely, the blood-brain barrier remains.

That barrier is constituted by special vessels in the brain and it

ought to be impenetrable to opioid peptides or other toxins. How

these so-called toxins get across is unknown. One molecule that is

large that does get across is leptin, which is a natural hormone,

but it has its own transporter. No such molecules are known. So

for a gut-derived peptide to be a cause of autism, one has to assume that a miracle occurs to cause the blood-brain barrier to open,

like the Red Sea did for Moses and the Israelites during the exodus

from Egypt.

Finally, there is no reason to assume that MMR is the only—or

even the most likely—reason for an association between gastrointestinal disease to be associated with autism. The nervous system

of the gut, the enteric nervous system, resembles the brain both

structurally and chemically, and is known to share its fate in other

conditions, including Alzheimer’s and Parkinson’s diseases.

It seems reasonable, therefore, to postulate that the incidence of

gastrointestinal symptoms in children with autism is high because

autism is a disease with manifestations in the gut as well as in the

brain. Alternatively, a brain that functions abnormally because of

autism may cause the bowel to function abnormally. Similarly, if

there is a problem in the bowel, it can disturb the brain.

Let me tell you, Mr. Chairman, as I prepared for this talk, I became painfully aware of the kinds of problems that can happen in

the bowel as the brain is disturbed. [Laughter.]

In summary, therefore, I think that there are alternative explanations for much of this and that the preponderance of evidence

and the nature of the function of the gut, liver, and blood-brain

barrier combine to indicate that it is unlikely that the hypothesis

associated with Dr. Wakefield that MMR vaccine causes autism is

correct. The idea that the measles virus persists in the gut of vaccinated individuals is supported only by data that is controversial

and has not been confirmed.

The proposal that the bowel leaks due to measles virus persistence and absorbs opioid peptides or other toxins assumes a oneway leak. Since leaks are intrinsically not one-way, but holes in a

barrier, body proteins or ions would be expected to flow out and no

such movement has been detected in MMR or autism.

The hypothesis that toxins are absorbed does not take filtration

by the liver into account or explain why gut-derived peptides are

not removed.

Finally, it does not explain why peptides can get through the

blood-brain barrier to cause autism and there are alternatives

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which are more plausible that can explain the association of GI

malfunction in autism that have nothing to do with MMR.

In closing, I would just like to say that I sympathize tremendously and empathize with patients with autism and their parents.

But it may be counterproductive for patients with autism, their

parents, and for the whole population to devote energy and resources single-mindedly to the pursuit of a single theory of autism,

when that theory might be false. The effort diverts scarce resources

from avenues that might be needed and productive and should be

devoted to this terrible condition.

Thank you.

[The prepared statement of Dr. Gershon follows:]

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Mr. BURTON. Let me just start off by saying that I know just a

couple of things. No. 1, there is an epidemic. There is a huge quantum leap in the number of children that are autistic. That is irrefutable. That is No. 1.

No. 2, I know that my grandson, Christian, was a normal child

starting to speak and doing everything that was normal and 1 day

he got the DPT shot, he got the MMR shot, he got the Hepatitis

B shot, the Polio shot, and the Marcus Influenza shot, and 10 days

later he had those bowel problems, had chronic diarrhea, ran

around hitting his head against the wall, flapping his arms, and he

could not talk anymore.

That may be just a coincidence, but it happened. I saw it with

my own eyes, so something happened. Whether it was the MMR

shot or the mercury that was in these other vaccines or a combination of the two, I do not know. But I do know that hundreds of

thousands of children in this country and around the world are suffering because of autism, and many of them are suffering from autism shortly after having received one or more of these vaccines.

Dr. Haley, you said that there was about a 10-fold occurrence of

autism in children who had the mercury vaccines and the MMR.

I am not sure exactly how you said it.

Dr. HALEY. I was not making any mention of the rate of autism.

Mr. BURTON. What were you saying?

Dr. HALEY. It is on the back page of the handout.

When you compare the toxicity against the bank of enzymes or

against enzymes in a brain tissue, if you add the vaccines that do

not contain thimerosal, they show the least amount of toxicity, essentially, very little at all.

Mr. BURTON. Right.

Dr. HALEY. If you use the same vaccine, only with thimerosal

added as a preservative, they are tremendously much more toxic.

Mr. BURTON. You said about 10 times, did you not?

Dr. HALEY. I am being very conservative; 1 microliter of these

vaccines will totally inhibit these enzymes. You can sometimes add

10 microliters of the non-thimerosal-containing vaccines and see

just a few percent——

Mr. BURTON. You also said that similar things occurred with the

MMR vaccine.

Dr. HALEY. We also measured the mercury level because some of

the vaccines we received had been used a bit. We looked at the

level of mercury. It fit what you would expect. There are low levels

of mercury in the non-thimerosal-containing vaccines. There is

some in all of them. The ones that had thimerosal added were

quite high.

The MMR came across as if it had no thimerosal added. There

was a small amount in there. I think it would be similar to those

that had no thimerosal added. There was mercury in there, but not

very much.

Mr. BURTON. There was mercury in the MMR vaccine?

Dr. HALEY. Yes, but a very small amount.

Mr. BURTON. But there was mercury in the vaccine?

Dr. HALEY. Yes, but the toxicity——

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Mr. BURTON. Merck, when we called awhile ago, said that there

was no mercury in the MMR vaccine. You are saying that there

was a very small amount.

Dr. HALEY. Yes, we found it. I would want to do 20 of them before I came up with an average, but we did find a small amount

of mercury. It was very tiny, though.

The MMR vaccine, unlike those vaccines without thimerosal, was

very toxic. It was as toxic as if it had thimerosal in it.

Mr. BURTON. So would you say it was 10 times more toxic than

a vaccine without thimerosal?

Dr. HALEY. I would say so, yes.

Mr. BURTON. Dr. Spitzer and Dr. Wakefield, I am sure you are

squirming there. Would you like to make any kind of comment

about what you just heard? [Laughter.]

Dr. WAKEFIELD. Generally, Mr. Chairman, or in specific relation?

[Laughter.]

Mr. BURTON. The whole hypothesis of your research was pretty

much trashed by the last two witnesses.

Dr. WAKEFIELD. I think Dr. Miller confuses inference with implication. She says that implicit in what we had written was a hypothesis. That, unfortunately, was her inference rather than our

implication.

What we have written—and this is one of the earliest articles

where we articulated a hypothesis—I am afraid this is in scientific

jargon—the hypothesis hypothesized that autistic enterocolitis is

an emergent, inflammatory bowel disease that follows a low-dose

compound viral exposure. Basically, that this subset of autism with

an inflammatory disease is an emergent form of inflammatory

bowel disease that follows a very atypical pattern of viral exposure

that requires not one virus but an interaction between viruses and

possibly other things as well.

And we go on in that same paper—and I will not go into the details because it is too much scientific jargon—but it comes back

very much to what Dr. Bradstreet was talking about. If the developing immune system is impaired in some way from developing an

appropriate anti-viral response to exposure to mercury or other

vaccines, if it is skewed in the wrong direction, then it may behave

aberrantly in the face of a virus.

I am very happy to provide Dr. Miller with a copy of this paper

and I will include one for your records.

Mr. BURTON. Thank you.

Dr. Spitzer.

Dr. SPITZER. I would first like to make a comment.

There has been implication about comparing benefits and costs

or good and harm in this situation. The understandable zeal, as indicating in the Institute of Medicine report, of coming close to wiping out a disease and the sequela of measles through the measures

that are being taken is a very laudable goal.

If we think, on the other hand, that say 10 percent only of autistic children are those in which we eventually find a link between

the disease and that vaccine were the case, a conservative estimate

is 150 children per 100,000 with autism—reducing it by 10 percent

is reducing 15 near deaths, if you wish, in the community.

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With respect to the other side of the coin, comparisons are almost

always made, as I have read them recently in the literature, with

no immunization at all as opposed to making the reference the best

acceptable alternative, which is univalent measles vaccine. The

grandchildren I have I want to have vaccinated, but with univalent

unless it is clarified.

That would reduce in UK statistics, which I only give in a preliminary way—I was just looking at them last Friday for the first

time—going from second to MMR meant a reduction of about 16

per 100,000 to usually zero or close to zero in developed countries

like the UK. It really is about the same, even if only 10 percent

of autistic children are affected.

That means it is important that we look at subsets, even small

subsets. If we can prevent 10 percent of autism by a more judicious

strategy of immunization, to that extent we will have balanced the

ledger of harm.

Last, I would like to stress in my case, I call myself a worried

agnostic. I do not know whether there is an association. I think the

evidence leans slightly in the direction of supporting an association.

Perhaps causation, but at least association. I only feel that I am

involved in one cause, and that is the pursuit of truth through scientific, admissible science, even if it takes 4 or 5 years to get to

the first step.

Mr. BURTON. Thank you, Dr. Spitzer.

Mr. Waxman, do you have some questions?

Mr. WAXMAN. Yes, I do.

Thank you, Mr. Chairman.

Dr. Wakefield, Marie McCormick is the Chair of the Institute of

Medicine’s Committee on Immunization Safety Review. She said at

the press conference at the release of the report that the MMR vaccine is as safe as a vaccine can get.

How do you respond?

Dr. WAKEFIELD. That is a very interesting comment. It is rhetorical inasmuch—let me put it this way. When the vaccine was first

put together in 1969, one of the concerns I had in particular was

that of interaction of viruses one with another. It is called viral interference.

Mr. WAXMAN. Dr. Wakefield, we are limited to 5 minutes each,

so I would really like a very terse and clear response.

Dr. WAKEFIELD. When the MMR was first put together, it was

evident that the viruses interacted one with another. That was assumed to be a benign process. That was a major mistake, in my

impression. I do not believe that when you put them together it is

a benign process. It alters the outcome from the vaccine, it alters

the immune response.

Mr. WAXMAN. Do you think the MMR vaccine is as safe as a vaccine can get?

Dr. WAKEFIELD. No, absolutely not.

Mr. WAXMAN. That is your view, but the Institute of Medicine is

not the only organization that disagrees with you. Your work has

also been scrutinized by the Medical Research Council and the

American Academy of Pediatrics and none of them has found any

evidence to support your hypothesis.

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Dr. Miller, in your testimony, you demonstrate that the proportion of autistic children with regression or bowel symptoms has not

changed over the period in which the MMR has been used in the

UK and is also no different for children who have never had an

MMR vaccination or those who developed autism after the vaccine.

What does that suggest about Dr. Wakefield’s theory?

Dr. MILLER. I obviously do not want to put hypotheses into Dr.

Wakefield’s mouth. The hypothesis I would infer that should be

tested on the basis of his suggestion of an autistic enterocolitis syndrome is that there should have been an increase in the proportion

of such cases with regression and bowel symptoms associated with

the use of MMR vaccine. I cannot find that in a large sample. I find

that at variance with any inferences I might make about what I

would expect to have happened on the basis of Dr. Wakefield’s

theories.

I therefore have to come to what I believe is a reasonable conclusion that my observation does not support his hypothesis.

Mr. WAXMAN. In other words, your new findings show that MMR

is not linked to bowel syndrome and is not linked to autism. And

this research, combined with the IOM report, really show that

there is no evidence to support a causal connection between autism

and MMR.

We have limited resources to devote to this cause. As a public

health official and an epidemiologist, do you think that more resources should be devoted to investigating the MMR-autism connection? Or are there better places to devote our resources?

Dr. MILLER. As I said in my testimony, I think the question of

what is the cause of autism—it is a common condition and we need

effective treatments—is extremely important to answer. I think

that there have already been quite a number of resources devoted

to the question of MMR and autism, both looking at the evidence

by expert committees plus individuals like myself doing as best we

can with epidemiological studies. These have been uniformly negative.

As I said in my oral testimony, one cannot rule out a rare idiosyncratic response. However, in relation to what is the major cause

of autism, I am firmly of the view that MMR has been excluded

as a major cause of autism. Therefore, I do not think it would be

profitable to—if you like—hijack the research agenda to concentrate on answering this question, which is derived basically

from speculation and unsubstantiated and, as yet, still unpublished

evidence in relation to MMR and autism.

Mr. WAXMAN. Thank you.

Dr. Gershon, an important part of Dr. Wakefield’s theory, as I

understand it, is that the measles virus persists in the gut. Yet

from what I understand, no other scientist has been able to replicate Dr. Wakefield’s findings of the persistence of measles virus

in the gut. Moreover, I also understand that Dr. O’Leary, Wakefield’s associate who does the looking for the measles virus, was

tested to see if he could correctly identify measles virus in infected

samples and he failed that test.

Do you know if that is correct? If so, can you explain the significance of this?

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Dr. GERSHON. It is correct. And the significance of it is that the

evidence we have heard—which is largely unpublished and is not

supported or duplicated by other laboratories—is not adequate to

support Dr. Wakefield’s hypothesis. So the evidence that the persistence of measles virus goes on in the gut is simply unfounded

at the moment.

Mr. WAXMAN. Mr. Chairman, I would like to ask unanimous consent if I could have another 5 minutes to pursue questions because

I have a conflict and have to run to another meeting.

Mr. BURTON. Go ahead.

Mr. WAXMAN. Dr. Haley, your research demonstrates thimerosal

inhibits enzyme activity and that demonstrates that the thimerosal, in your experience, is dangerous to the enzyme in the petri

dish.

Don’t we need to know how much thimerosal is in the vaccine before we know whether it is dangerous to a human being?

Dr. HALEY. Toxicity is always related to dose, but also size, the

ability to clear it, the health of the patient, the metabolic status,

if they were suffering from a spurious ailment it would be more

toxic.

Mr. WAXMAN. So the research you are presenting today does not

definitively answer the question of whether the amount of thimerosal in childhood immunizations is dangerous or not, does it?

Dr. HALEY. That it is dangerous?

Mr. WAXMAN. Yes.

Dr. HALEY. I think if you consider the aspect that we are dealing

with multiple toxicities and exposures to mercury from a lot of different sources that adding an abundance of mercury to a child—— Mr. WAXMAN. My question, though, is whether the amount of thimerosal in the childhood immunizations is dangerous, the amount

that is in there. There may be other exposures.

Dr. HALEY. The amount from the vaccine alone would probably

be not enough by the data we have seen. But again, that would depend upon the health of the patient you are giving it to.

Mr. BURTON. Would the gentleman yield?

Mr. WAXMAN. Sure.

Mr. BURTON. Is there a cumulative effect of mercury—— Dr. HALEY. Yes.

Mr. BURTON. In other words, my grandson—and I appreciate you

yielding—got nine shots. I think four or five of those shots he got

on that 1 day contained mercury. They said that was 41 times

what was normal.

Would that cumulative effect have an adverse impact?

Dr. HALEY. Absolutely.

Mr. BURTON. Did you hear that, Henry?

Mr. WAXMAN. What was that answer? [Laughter.]

Dr. HALEY. There are a lot of reports out there with infants that

have been exposed to excess ethyl mercury generating compounds.

Mr. WAXMAN. Are you aware of an abstract study funded by NIH

that looked at the blood mercury levels of full-term infants following the administration of thimerosal-containing vaccines?

Dr. HALEY. Yes, I am. My opinion on that is that blood mercury

levels have been considered by many people not to be worth very

much to the extent of mercury toxicity. It is a retention toxicity.

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Mr. WAXMAN. I would like to read the conclusion of that abstract. ‘‘Low levels of mercury can be detected in the blood of some fullterm infants following the administration of vaccines containing

thimerosal. None of the blood mercury levels observed in the studied infants exceeded the most recently revised lowest level of maternal blood mercury considered to represent a potentially significant exposure to the developing fetus.’’ That seems to disagree with your testimony. That seems to be at

odds with what you are saying.

Dr. HALEY. If anybody is saying they can look at the level of mercury in blood after a vaccination and then come to the assumption

that this did no harm to that patient, I sincerely disagree with

them.

Mr. WAXMAN. Does the research you have represented today

prove that the mercury in vaccines causes autism?

Dr. HALEY. Absolutely not.

Mr. WAXMAN. In your testimony, you stated that infants cannot

clear mercury from their bodies. But a recent study conducted by

the University of Rochester testing mercury in infants found that

mercury was detected in the infants’ feces.

Don’t these findings prove that infants can clear mercury from

their bodies?

Dr. HALEY. I did not say they could not, I said that they could

not do it as well. They have reduced bilary transport. It takes a

while for that to develop. And from what I understand, they get the

vaccination on the day they are born.

Mr. WAXMAN. Dr. McDougle, first I want to begin by commending you for the excellent work you are doing to advance our understanding of how to treat autism. Much of your attention is focused

on determining the causes of autism, and that is important, but it

is also important to help individuals and families who are suffering

now.

I understand you are in the middle of a 5-year grant to develop

medications to treat the symptoms of autism. Can you give us a

preliminary assessment of the effectiveness of some of the medications you are studying?

Dr. MCDOUGLE. Yes. I would say that the first study we completed was with a medication called Risparidone. Although the

blind has not been broken yet and we are not aware of who was

on which placebo or drug, certainly a number of children have improved and benefited with particular improvements in the areas of

aggression, self-injury, irritability, and I think has ultimately improved their quality of life.

Mr. WAXMAN. So some of them are working?

Dr. MCDOUGLE. Yes.

Mr. WAXMAN. Thank you very much, Mr. Chairman and my colleagues.

Mr. BURTON. I hope you did not miss the response from Dr.

Haley on that one thing because we have asked this question of

others when you were not in attendance, and that is that the mercury in the vaccines has a cumulative effect. If the child gets eight

or nine shots in 1 day, as my grandson did, he is getting an exorbitant amount of mercury in one dose. In my grandson’s case, 10

days later he was autistic.

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Dr. Weldon.

Mr. WELDON. I want to thank all the witnesses. For me, personally, I am just trying to find out how we can direct our research

funding better to try to get some answers to some of these questions.

Dr. Miller, you described the Public Health Lab as being a nongovernmental public body. Do you get funding from the British

Government, though?

Dr. MILLER. Yes, in the same way the National Health Service

is funded by the British Government, but we are not an arm of government. Our relationship to the Department of Health and Government is the same as the UK National Health Service.

Mr. WELDON. Is all your funding from the government? Or does

some of it come from other entities? Specifically, does any of it

come from the pharmaceutical industry?

Dr. MILLER. Our core funding comes from the government. As

with the National Health Service, researchers like myself apply for

funding from research agencies, research funds from the Department of Health. I have no commercial interests in any vaccine company. I do not act as a consultant or an advisor to a vaccine company. I do, along with other individuals, have research funds for

specific studies, largely clinical trials, from vaccine companies. I

have not been sponsored from any of the work that I do on autism

from vaccine companies.

I should say that in relation to the circumstances under which

any funding comes from such commercial sources, the legal department of the Public Health Laboratory Service draws up a very

stringent contract with the commercial company to ensure that

there is total scientific independence of the PHLS in publication

and interpretation of those results. This is a standard procedure for

organizations such as the PHLS.

Mr. WELDON. So you are saying that the funding comes from the

British Government and some of it does come from pharmaceutical

companies, but you have these—— Dr. MILLER. A small amount for specific research projects.

I am also an advisor to the Medicine Control Agency, that is

similar to the FDA. And as a requirement for that, we have a declaration of interest. Should members of the committee wish to see

the funding I have received and for what purposes, then they are

free to view that. I am not sure if it is on the MCA Web site.

So there is a full declaration of interest. The ability to provide

independent scientific advice is scrutinized by the MCA in relation

to the type of financial benefit that is received for research studies

from companies. I have not been prevented from having any input

over advisory matters in relation to the research funding that I

have received.

I should say, it is a very small proportion of the total amount I

have received for research studies.

Mr. WELDON. It would be very comforting to me if the PHLS would just spend $500,000 and try to recruit 50 kids with autistic

spectrum disorder and gastrointestinal symptoms and just scope

them and try to duplicate his findings. It is very little comfort to

me, all these epidemiologic studies, because the hypothesis is not

that MMR causes all forms of autism. If you are operating under

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the assumption that MMR causes a small percentage of the cases

of autism, then that may be very, very difficult to detect in an epidemiologic study.

If the British Government is all concerned about vaccination

rates declining because of Wakefield’s findings, why don’t they just

scope 50 kids? What is the problem?

Dr. MILLER. I would like to say first of all that you have put your

finger on the nub of the question here. I think you have accepted

that the epidemiological evidence has already excluded MMR as a

common cause of autism. I said in my testimony that it is impossible epidemiologically to prove that it could never cause it.

So the question is, for how rare an event would you like a study

to be set up to exclude or to find that sort of risk?

For the purposes of spending public money, if one has excluded

MMR as a frequent cause of autism——

Mr. WELDON. I would like to interrupt you, because I have a limited amount of time.

He came in my office and showed me the pictures. I have spoken

to people. I am an internist. These kids have florid inflammatory

bowel disease. Why can’t somebody duplicate this study?

We have this poor, lone guy coming here constantly, year in and

year out. [Laughter.]

And Dr. O’Leary, might I say, is the guy who identified Herpes

Simplex Type A. He came here to the NIH and all of the people

at NIH supposedly dismissed it as being invalid and ultimately it

was found to be true that Herpes Simplex Type A causes

carposisarcoma. O’Leary is a very, very reputable scientist.

Why can’t we repeat O’Leary’s data?

Dr. MILLER. First of all, we have to wait to see the virological

findings published in a peer-review journal. As Dr. Gershon said,

we have not yet seen those.

The Public Health Laboratory Service, as I mentioned, its remit

is the national diagnosis, surveillance, and prevention of communicable disease. Autistic enterocolitis, as far as I am aware, is not

demonstrated to be a communicable disease, nor indeed to result

from vaccination.

Now whether there is a syndrome called autistic enterocolitis

which has distinctive pathological features, fenotific presentation is

another question. And maybe gastroenterologists, in combination

with autism experts should be looking at that. It is not a question

for PHLS.

Mr. WELDON. The responsibility to duplicate his work is not

something that your department would——

Dr. MILLER. Our responsibility would relate to the question, if

there is such a syndrome, Is there evidence that it is associated

with MMR?

Analyses of that has come to the conclusion that no—whether or

not there is such a syndrome, whether or not it has relevance to

the current prevalence of autism is another question, and academic

institutions with expert gastroenterologists and autism experts

may indeed be looking at this.

I would say the Medical Research Council has funded a large

study to look at the question of etiology of autism and what the

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risk facts are to try to throw some light on it, but it is not a question related to vaccines or communicable disease.

Mr. WELDON. I have some questions for Dr. Gershon.

This is not published, but I have been told by some of the people

doing research in treating children with autism that a substantial

percentage of them do have elevation in their liver function tests.

If that were published and proved to be true, would that affect

your opinion regarding this theory of these neuroactive peptides?

Dr. GERSHON. It would affect my opinion if the elevation of liver

function tests were such that it would affect the ability of the liver

to act as a filter.

Mr. WELDON. So you would want to see very significant elevations, not very mild elevations.

Dr. GERSHON. For example, jaundice.

Mr. WELDON. You would want to see jaundice?

Dr. GERSHON. I would like to see some evidence that the liver is

failing in its job as a filter. I would also like to have some evidence

that material is moving from into the gut from the body. I would

like to see some evidence that the intestinal epithelial barrier is

failing. And I would like to see some mechanism to get whatever

toxins are so-called absorbed through the blood-brain barrier.

Mr. WELDON. Regarding the blood-brain barrier, it was brought

to my attention that a Dr. Connolly published in the Journal of Pediatrics in May 1999. Maybe you might be familiar with this study.

The title of the article was ‘‘Serum Autoantibodies to Brain in Landau-Klefner Variant, Autism, and Other Neurologic Disorders.’’ It

was basically showing antibodies to brain endothelium.

Are you familiar with that study at all?

Dr. GERSHON. I have seen the study.

Mr. WELDON. That does not affect your opinion at all about this

theory? That study has no impact?

To me, that study suggests that there could be a possible link

and explanation here. I am not saying there is, as a scientist myself. I think I would want to see more research. But you dismiss

the theory outright, and that study suggested to me that in some

of these kids there may actually be a breakdown in the blood-brain

barrier.

Dr. GERSHON. That study did not demonstrate a breakdown in

the blood-brain barrier. It showed autoantibodies. That is a different issue.

The existence of antibodies—it could be an autoimmune mechanism, I guess, is what you are implying—that helps to break the

blood-brain barrier down. There could be a lot of things.

Every step along the way, an improbable event could happen.

But there are a lot of steps along the way.

I would like to direct your attention to two other points. One part

of my testimony and one further one.

I pointed out that there are alternative mechanisms by which to

explain the association between bowel disease and autism. One

need not postulate a set of improbable mechanisms to get toxins

into the brain. The bowel and the brain communicate by other

means. The fact that both are involved in autism is, to me, established. As I said at the outset, Professor Wakefield is to be commended for publicizing that.

199

On the other hand, I do not think it is established that the reason for the link is MMR. The bowel has many mechanisms of affecting the brain and the brain the bowel. The same disease, autism, can give rise to symptoms in both places.

The other thing, in regard to what you said about scoping—if the

British Government or our Government were to scope a lot of children and find inflammation in the bowel, I would expect that they

would in fact find that. Nobody, to my knowledge, is quarrelling

with the aspect of what Dr. Wakefield has published, which is that

some children with autism have in fact inflammatory bowel disease. That is not in contention. What is in contention is that resulted from MMR and that there is persistent measles virus in it,

that what they detect is not just passenger leftover from the vaccine that is not real virus.

It is very hard to show that. And Professor O’Leary—I am not

saying he is not a good molecular biologist. I think he is an excellent molecular biologist. But when asked with coded samples that

were sent to him by Michael Oldstone to show that he could detect

these low copy numbers which are postulated, he did not pass the

test. He identified successive samples differently on different occasions. He missed some diagnoses. When there were very large

amounts of measles virus, he could detect it, as could everybody

else.

And here we have a situation where other laboratories are trying

to duplicate this finding of measles virus, and they are not doing

it. Yet this laboratory has failed the test of coded samples to do it.

Mr. WELDON. Mr. Chairman, could we have Dr. Wakefield?

Mr. BURTON. Dr. Wakefield.

Dr. WAKEFIELD. I am sorry, I have to take issue with that. That

is a complete misrepresentation of the data.

First, Dr. Gershon suggests that other people have looked in the

intestine of these children for the detection of measles virus. No

one has done that, to my knowledge. So the only laboratory that

has looked in the intestinal biopsies of these children is Dr.

O’Leary’s laboratory. Other people have looked in the intestines of

children with Crohn’s Disease for evidence of measles virus, which

we have suggested. Indeed, one of the people on the panel of the

IOM presented data at the American Academy of Pediatrics last

June showing that they had could identify measles virus genetic

material in children with Crohn’s Disease and some controls.

I want that to go on record. That has been presented.

So independently groups from Canada and from Japan have

found measles virus in the intestines of children with inflammatory

bowel disease.

The issue of the study with Michael Oldstone was not as it was

portrayed. I am very, very concerned that Michael Oldstone should

breach confidence of data that has not been presented in any

forum, and has not even actually been finally analyzed. But in fact

when they did analyze them, the only discrepancy was that there

was no contamination at all, but a very, very, very low copy number of the virus, which the tacman PCR system—which Dr. O’Leary

helped develop—detects the virus found that they might be able to

detect it in two out of three samples.

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This is merely a function of low copy viral detection. It is now

a function of the ability of us to find viruses in vanishing small

amounts with technology that is not available in Dr. Oldstone’s lab.

So the data have not been presented fairly, and I want that to go

on record.

Mr. BURTON. Dr. Weldon, you can keep the time, but I want to

make a comment or two because I have no more questions for the

panel. Then I will let you conclude the questioning.

A lot of kids are ruined for life. I detect a close-minded attitude

on something that is so important—not to one child, my grandson,

but to hundreds of thousands of kids. Every 3 hours in California—

it was every 6 hours just about a year ago—but every 3 hours in

California, there is a new child with autism. Every 3 hours.

It is a horrible, horrible thing to have to live with, not just for

the child but for the parents, the grandparents, and everybody else,

not to mention the cost.

So we have some people that have a closed mind about various

theories about this. I think this is a time for everybody to be open

to almost any theory, if it is cost-effective, to look at it to see if it

can be proved or disproved.

I want to tell you a story. Louis Pasteur was kicked out of the

medical profession and ostracized for 17 years and then he was

knighted. And it was because everybody had a closed mind.

I have a very good friend who lives in Australia. His name is Dr.

Barry Marshall. I do not know if you have ever heard of him or

not. But I went to Africa and I was in the jungles of Angola and

I came down with a bug, I thought, because I could not eat anything or keep it down for 2 years. It was awful. So I went to gastroenterologists. I went to several of them. And they all said it was

my nerves and strain on my body. They gave me Zantac and

Prilosec and everything else under the sun.

Then I read this article about this guy named Barry Marshall.

I think it was in one of the major publications. He was a scientist

doctor from Australia. He said that the stomach problems in 90

percent of the people in the world was caused by a bacteria. Everybody said that a bacteria cannot live in the stomach.

He went and gave a speech to a symposium in Belgium. After he

gave the speech—or right near the end—they literally started

laughing at him because it was impossible for a bacteria to live in

the lining of the stomach and he was crazy. So he went home and

drank the bacteria—not unlike what Louis Pasteur did. He went

home and drank it and got deathly ill and cured himself with the

combination that he gave me.

I went down to see him after 2 years of suffering and he tested

me. My doctor said I didn’t have that. But I went to see him and

he gave me this concoction of bismuth and antibiotics and something else. I took it for 2 weeks and I have not had a problem since.

But the close-minded doctors who were experts, who had all the

answers, told me that I could not be cured, that I had to take these

stomach pills for the rest of my life. All I can tell you is that we

have a problem with kids that is humongous. It is going to affect

the whole world if we do not do something because we are vaccinating kids all over the world. If mercury or the MMR vaccine or

201

whatever it is is causing it, we need to find out and we need to find

out pretty darn quickly.

For people to have closed minds when 1 out of 150 or 200 kids

in Oregon or 1 out of 400 in the United States or 1 in 500 in the

United Kingdom are coming down with autism is almost criminal.

You ought to explore everything to find out what the answer is.

With that, I will shut up.

[Applause.]

Mr. BURTON. Dr. Weldon.

Mr. WELDON. I just have a couple of quick followup questions.

Dr. Wakefield, Dr. O’Leary came in my office and showed me his

PCR data, all the different versions of that. I think he ran eight

different types of tests. Why hasn’t that been published yet? We

have had Dr. Gershon point that out repeatedly that it has not

been published. What is the problem?

Dr. WAKEFIELD. There is no problem. It is being presented for

the first time at the American Gastroenterological Association in

Atlanta in May. It has been peer-reviewed and we will see how

that goes. But it is awaiting publication at the moment.

We have been asked to provide strain-specific sequencing. In

other words, the acceptance is that the virus may well be there. I

sat down with Michael Oldstone himself who said that he accepted

that we found the virus. NIH’s measles expert who came to troubleshoot this said that the virus is there. But the reviewers have

asked for strain-specific sequencing. Those studies are being conducted at the moment and we will put those into the papers. It is

an entirely reasonable question and one that we are answering.

Mr. WELDON. So you expect publication after that issue is decided?

Dr. WAKEFIELD. Once we have addressed that issue, yes.

Mr. WELDON. Just one more question for you, Dr. Miller.

Were you on the original panel that approved the MMR in England?

Dr. MILLER. No, I had no role in that at all.

Mr. WELDON. That is all I have, Mr. Chairman. Thank you.

Mr. BURTON. I want to thank you all very much. You have been

very patient. You have been sitting for a long time. You have been

very helpful.

We will submit all your statements and all your comments to the

health agencies here. We will continue to fight on to try to find a

solution to this problem, with your help.

Thank you.

We have one more witness who could not be with us tomorrow,

Dr. McCormick from the Institute of Medicine. She is the chairman

who did the report that we had heard about.

Dr. Weldon, you can stay for Dr. McCormick, I hope. She was the

chairman of the committee that did the report that was recently released. I need you.

[Witnesses sworn.]

Mr. BURTON. Do you have an opening statement, Dr. McCormick?

Dr. MCCORMICK. Yes, I do.

Mr. BURTON. You are recognized.

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STATEMENT OF MARIE MCCORMICK, MDSCD, CHAIR, COMMITTEE ON IMMUNIZATION SAFETY REVIEW, INSTITUTE OF

MEDICINE, ACCOMPANIED BY WILLIAM COLGLAZIER, EXECUTIVE OFFICER, NATIONAL ACADEMY OF SCIENCES; AND

SUSANNE STOIBER, EXECUTIVE OFFICER

Dr. MCCORMICK. Good afternoon, Mr. Chairman and members of

the committee.

My name is Marie McCormick. I am a professor and Chair of the

Department of Maternal and Child Health at Harvard School of

Public Health and I Chair the Institute of Medicine’s Committee on

Immunization Safety Review, which released its report on MMR

Vaccine and Autism on Monday, April 23rd. I appreciate the opportunity to provide testimony to you based on the findings of this report. A copy of my testimony and the executive summary has been

submitted for the record.

Dr. William Colglazier, executive officer of the National Academy

of Sciences, and Ms. Susanne Stoiber, executive officer of the Institute of Medicine accompany me.

As I mentioned, two committee members are here, Dr. Steve

Goodman and Dr. Constantine Gatsonis.

The genesis of this report was a December 1999 discussion between the CDC and the IOM regarding the need for an independent group to examine vaccine safety concerns. The CDC and NIH

formally engaged the services of the Institute of Medicine in September 2000, which in turn appointed the committee in November

2000.

The committee is comprised of 15 members with expertise in pediatrics, immunology, neurology, infectious disease, epidemiology,

biostatistics, public health, genetics, ethics, risk perception, and

communication. To preclude any real or perceived conflicts of interest, committee members were subject to strict selection criteria

that excluded anyone who had participated in research on vaccine

safety, received funding from vaccine manufacturers or their parent

companies, or served on vaccine advisory committees.

The committee is charged with examining three vaccine safety

issues each year for 3 years. The committee was asked to assess

the scientific plausibility of the safety concern, the significance of

the issue in a broader social context, and to suggest appropriate actions. The first hypothesis the committee was asked to consider is

the linkage between MMR vaccine and autism.

The MMR vaccine has been extremely successful in virtually

eliminating measles, mumps, and rubella in the United States.

Measles cases, for example, dropped from over 400,000 per year in

the pre-vaccine era to only 100 in 1999.

Some are concerned, though, that the MMR vaccine might cause

autistic spectrum disorders. These are incurable, permanent, and

serious developmental problems in children and adults. Scientists

generally agree that most cases of autistic spectrum disorders result from events that occur in the prenatal period or shortly after

birth. However, concern arises about the MMR vaccine because autistic symptoms typically become more evident in the child’s second

year, about the same time the MMR vaccine is first administered.

A growing body of work has examined this subject. In a study

published in the Lancet in 1998, researchers describe 12 children

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who developed behavioral problems, including autism, shortly after

receiving the MMR vaccine. Since then, this group and others have

further examined this potential relationship.

To evaluate the hypothesis on MMR vaccine and autistic spectrum disorders, the committee conducted an extensive review of the

published, peer-reviewed scientific and medical literature. We held

an open scientific meeting including a broad group of researchers

and vaccine safety advocates. Finally, a working group of the committee conferred with parents of autistic children and vaccine safety advocates to discuss their concerns.

The committee concludes that the evidence favors rejection of a

causal relationship at the population level between MMR vaccine

and autistic spectrum disorders. The committee bases this conclusion on the following evidence: a consistent body of epidemiological

evidence shows no association at a population level between MMR

vaccine and autistic spectrum disorders; the original case series of

children with autistic spectrum disorders and bowel symptoms and

other available case reports are uninformative with respect to causality; biologic models are fragmentary; and there is no relevant

animal model.

However, the committee notes that its conclusion does not exclude the possibility that MMR vaccine could in rare cases contribute to autistic spectrum disorders resulting in a very small number

of affected children. This possibility arises because the epidemiological evidence lacks the precision to assess rare occurrences and the

proposed biological models, although far from established, are nevertheless not disproved.

In its significance assessment, the committee considered the burden of measles, mumps, and rubella infections, the burden of autistic spectrum disorders, and the level of public concern. Measles,

mumps, and rubella can lead to significant morbidity and mortality

and treatment of these diseases is limited.

Outbreaks of measles, mumps, or rubella disease could easily

occur now were MMR immunization rates to decline as a result of

fears about MMR. Yet, because MMR vaccine is a mandatory vaccine that is administered to healthy children—in part, as a public

health measure to protect others—the responsibility of the Government to ensure the safety of the vaccine is high. The burden of autism, an incurable and serious disorder, requires consideration of

all possible etiologies. In addition, the level of public concern about

MMR vaccine safety is high.

Because of the limitations of the evidence, the significant public

concern surrounding the issue, the risk of disease outbreaks if immunization rates fall, and the burden of autism, the committee recommends that further attention be given to this matter.

Specific recommendations regarding policy review, research and

surveillance, and communication follow.

In terms of policy review, the committee does not recommend a

policy review at this time of the licensure of the MMR vaccine or

of the current schedule and recommendations for administration of

MMR.

The committee concludes that further targeted research on the

possible contribution of MMR vaccine to autistic spectrum disorders in some children is warranted. For example: use accepted

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case definitions and assessment protocols for autistic spectrum disorders to enhance the precision and comparability of research results; explore whether exposure to MMR vaccine is a risk factor for

autistic spectrum disorders in some children; explore whether measles vaccine-strain virus is present in the intestines of some autistic children; and encourage all who submit reports tot he Vaccine

Adverse Event Reporting System about MMR vaccine and autism

to provide as much detail and documentation as possible.

The committee heard from parents that obtaining unbiased and

accurate information on the possible relationship between MMR

vaccine and autistic spectrum disorder has been difficult. The committee recommends that governmental and professional organizations, CDC and the FDA in particular, review some of the most

prominent forms of communication regarding the relationship between MMR vaccine and autism spectrum disorder. Direct input

from parents and other stakeholders would be invaluable in conducting an evaluation of communication tools.

In its discussion of recommendations, the committee identified

more general concerns that it could not adequately address in this

report. It intends to address these in the future.

This concludes my oral statement and I would be happy to answer any questions.

[NOTE.—A copy of the Institute of Medicine publication entitled, ‘‘Immunization Safety Review,’’ may be found in committee files, or

obtained by calling the National Academy Press at 1–800–624– 6242.]

[The prepared statement of Dr. McCormick follows:]

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Mr. BURTON. Thank you, Dr. McCormick.

What does this mean? ‘‘However, the committee notes that its

conclusion does not exclude the possibility that MMR vaccine could

contribute to ASD in a small number of children because the epidemiological evidence lacks the precision to assess rare occurrences of

a response to MMR vaccine leading to ASD and the proposed biological models linking MMR vaccine to ASD, although far from established, are nevertheless not disproved.’’

What does that mean?

Dr. MCCORMICK. What that means, I think is what Dr. Miller

said, that the level of analysis you are able to do could not rule out

rare occurrences.

In terms of the biological model, we were talking specifically

about the type of evidence Dr. Wakefield had presented. Unfortunately, because it was an open meeting, Dr. Wakefield was reluctant to present his full range of data because it would also have

to be put out on the Web and it was considered pre-published.

Mr. BURTON. I understand, and I do not want to cut you off, I

just want to bear on this question.

On television all across the country, we saw yesterday that our

health agencies and your committee said that the MMR vaccine

was not going to be a contributing factor and could not cause autism.

Dr. MCCORMICK. Based on the evidence that we got to the committee, that is true.

Mr. BURTON. What does this mean, that you just said?

Dr. MCCORMICK. We are leaving the door open for additional evidence because we could not hear the evidence that was being presented. We were not provided the evidence on the presence of measles vaccine. It does not mean that that whole theory is going to

be proven, we are just saying——

Mr. BURTON. Let me read this to you again, ‘‘although far from

established, are nevertheless not disproved.’’

So what you are saying is that the causal link is not disproved.

Is that right?

Dr. MCCORMICK. No, we are saying it is not established.

Mr. BURTON. But you are saying that it is not disproved.

Dr. MCCORMICK. It is not established, either.

Mr. BURTON. So you do not know, do you? Can you say categorically, 100 percent, that the MMR vaccine is not a contributing factor to autism? Can you say that?

Dr. MCCORMICK. No, because we said in rare cases.

Mr. BURTON. That is the point. You put out a report to the people of this country saying that it does not cause autism, there is

no causal link, and then you have an out in the back of the thing.

You cannot tell me, the committee chairman, under oath, that

there is no causal link because you just do not know, do you?

Dr. MCCORMICK. Because in part we were not provided the

evidence——

Mr. BURTON. Do you know?

Dr. MCCORMICK. I do not know.

Mr. BURTON. Then why did you say so in the report?

Dr. MCCORMICK. Because the bulk of the evidence——

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Mr. BURTON. Because the bulk of the evidence? But you do not

know. You just said that.

Dr. MCCORMICK. In fact, most of the reports I saw indicated that.

Mr. BURTON. Do you know what it is like to have an autistic

child?

Dr. MCCORMICK. I do.

Mr. BURTON. You have an autistic child?

Dr. MCCORMICK. No. My brother has two.

Mr. BURTON. Your brother has two?

Dr. MCCORMICK. Yes.

Mr. BURTON. Then you know what he goes through?

Dr. MCCORMICK. Yes.

Mr. BURTON. Do you know how many kids are getting autism?

Every 3 hours in California, there is a new child with autism. It

used to be every 6 hours. You used to have 1 out of every 10,000

kids who were autistic.

We do not know all the answers. We do not know if the mercury,

the thimerosal in the vaccinations are causing autism. You do not

know for sure whether the MMR vaccine is causing autism.

Dr. MCCORMICK. I know it is not causing most of the cases of autism.

Mr. BURTON. But the point is, if you are the one that it does

cause—if your child is the one that does get it and we find out

there is a causal link, isn’t that awful? Isn’t that awful?

I just have to tell you, as I said to the last panel—and you heard

what I said about Louis Pasteur and Dr. Barry Marshall, didn’t

you?

Dr. MCCORMICK. Yes.

Mr. BURTON. This is such a serious thing with hundreds of thousands of people that are going to be autistic and be a burden on

society for the rest of their lives, it is going to cost us trillions of

dollars—when you talk about 1 in 250 or 500 kids—they are going

to grow up and they are going to be a burden on society. We should

not close the door to any avenue of research to find out what is

causing that.

It is not being caused just by genetics, I do not believe, because

you are having a huge quantum increase in it. Something is causing it and we ought to be open to everything.

Dr. MCCORMICK. In fact, the report, sir, does recommend continued attention to this linkage.

Mr. BURTON. I know, but that is not the point.

Of course, I read that. But most people in this country did not.

All they heard on television was that there is no causal link, none.

I heard doctors saying that this has been studied by experts not

connected to the pharmaceutical industry.

Now let me ask another question, because this is pretty important, too.

You sent this report out to a group of people to look at, didn’t

you?

Dr. MCCORMICK. I did not send out the report.

Mr. BURTON. Somebody sent it out, did they not?

Ms. STOIBER. I am sorry. I would answer those questions because

the committee is not responsible, the Institution is.

Mr. BURTON. Stand up and be sworn.

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[Witness sworn.]

Mr. BURTON. Did you send out the report to be reviewed?

Ms. STOIBER. Not personally, but institutionally, we sent out the

report.

Mr. BURTON. And you sent it to Linda Cowan, Eric Fombonne,

Neal Halsey, Samuel Katz, among others, right?

Ms. STOIBER. That is correct.

Mr. BURTON. Neal Halsey and Samuel Katz are people that do

not subscribe to the theory that the MMR vaccine might be a contributing factor, right?

Ms. STOIBER. I have no idea, sir, what they subscribe to.

Mr. BURTON. Well, let me tell you they do. Those two people do

not believe that the MMR vaccine is a contributing factor to autism.

You sent it to them for review, and I presume they went through

it and might have made some modifications—I do not know—but

you did not send it to Dr. Wakefield who is on the other side of

the issue. Why?

Ms. STOIBER. When we select a review panel—and there are 15

reviewers to this report—we try to select people from all sides of

an issue, those who believe there are connections and those who

believe there may not be connections. I think in fact there are three

reviewers that were specifically selected because they have the confidence and have been engaged in the research that would in fact

be supported by the advocates of this connection.

We take into account all of the reviews carefully. The reviewer’s

comments are blinded. We do not know who they are when we receive them. And no reviewer ever has the power to change a word

in our report.

Mr. BURTON. Were any of these people presenters at the conference?

Ms. STOIBER. Yes, two of the people were.

Mr. BURTON. Who were they?

Ms. STOIBER. Dr. Fombonne and Dr. Miller.

Mr. BURTON. Did Dr. Halsey or Katz, either one, present?

Ms. STOIBER. They did not.

Mr. BURTON. They did not?

Ms. STOIBER. No.

Mr. BURTON. Halsey and Katz have financial interests in pharmaceutical companies. Fombonne and Miller did present?

Ms. STOIBER. That is correct.

Mr. BURTON. And they did not agree with the thesis——

Ms. STOIBER. I am sorry. Dr. Miller did not present. It was Dr.

Volkmar, Ward, and Fombonne.

Mr. BURTON. Dr. Fombonne was one of the people who reviewed

it and he was a presenter on the other side of the issue, as I recall.

He believed the MMR vaccine was not in any way associated with

the autism.

Ms. STOIBER. He reported the results of his study, which showed

no association.

Mr. BURTON. And Dr. Wakefield was on the other side of the

issue. He was a presenter, as well, but he was not given a copy of

this to review.

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Ms. STOIBER. The reviewers, sir, were not selected because they

were presenters, but were selected because they represented a wide

spectrum of views on the subject. The fact that two of them also

presented was totally coincidental and they were selected for their

ability to provide a broad assessment of the evidence.

Again, we tried to balance, always, the reviewers selected so that

those who have opposing views are equally and well represented

among the reviewers.

Mr. BURTON. Do you know if any of the people that reviewed it—

other than the ones I mentioned—had financial interests or connections with any pharmaceutical companies that produced the MMR

vaccine?

Ms. STOIBER. To the best of our knowledge, they do not. In fact,

we do not do the same kind of extensive review of the financial

holdings of reviewers that we do of committee members. But to the

best of our knowledge, aside from the fact that they may own mutual funds that hold pharmaceutical stocks, there is no reason to

believe there are any financial ties.

Mr. BURTON. In the past, we have subpoenaed from the health

agencies—and we are still going through them—the financial disclosure forms of people in the decisionmaking process who make

decisions on these vaccines. So therefore I would like to know—and

we would like for the Institute of Medicine to contact the people on

the review committee and ask them to submit to us any holdings

they have in pharmaceutical companies. If I have to, I will subpoena that.

Would you tell them? And any that are connected with an institution that gets grants from the pharmaceutical companies.

Ms. STOIBER. I will first say, sir, that they are not in a decisionmaking process.

Mr. BURTON. I understand. They were in the review process.

Ms. STOIBER. They solely reviewed. And after their reviews were

received, the committee had the ability to assess whether or not to

accept any of that advice. Some was accepted and some was rejected.

Mr. BURTON. When it was accepted, did it involve any changes?

Ms. STOIBER. Very few.

Mr. BURTON. Were any changes made after——

Ms. STOIBER. Always changes are made in response to review because reviewers point out weaknesses in the analysis, they point

out lack of clarity in the expression, but I can say to you that no

central conclusions changed during the course of review.

Mr. BURTON. We will take a look at that and I will make the decision on that after I review all this. But I want to know about the

reviewers and what recommendations they made and changes. I

would like to have that. I would also like to know whether or not

they had any interest or got any grants of any kind from any pharmaceutical companies. I would also like to have that information

from any of the people on the original report panel.

According to our request, we wanted to make sure that these

people are insulted who are working on this report from any influence being exerted by any pharmaceutical company. I would like to

find out if any of the people who were on that panel who wrote the

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report if they have any financial interest or ties and whether they

got any grants from any pharmaceutical companies.

I wish you would take that request back to the agency and tell

them that, if necessary, we will be glad to send them a subpoena

to get this information.

Ms. STOIBER. I can assure you that no member of the committee

has any financial ties to the pharmaceutical industry.

Mr. BURTON. How about grants?

Ms. STOIBER. Or grants. I do not have the authority to tell you

that we can deliver the financial background of reviewers, but I

will certainly take that back the Academy and assess it and get

back to you.

Mr. BURTON. You can tell them that I would like to have it and

if they choose not to send it, I will send them a subpoena and I

will get it.

Ms. STOIBER. I think we do not have the detailed financial statements of the reviewers.

Mr. BURTON. Then how can you tell me right now that they do

not have any financial interests?

Ms. STOIBER. Of the reviewers.

Mr. BURTON. How about the people on the panel?

Ms. STOIBER. For those on the panel, we have extensive financial

disclosure.

Mr. BURTON. Then I want it.

Ms. STOIBER. What we do not have is the same kind of information for people who served as reviewers.

Mr. BURTON. We want that and we want to know if they got any

grants of any kind from any of the pharmaceutical companies.

Dr. Weldon, sorry to take so much time.

Mr. WELDON. Mr. Chairman, I ask unanimous consent to introduce for the record a statement from the Middlebrook Family of

Indialantic, FL, in my congressional district, who have struggled

with autism.

Mr. BURTON. Without objection, that prepared statement will appear in the record.

[The prepared statement of Mr. and Mrs. Middlebrook follows:]

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Mr. WELDON. Dr. McCormick, you were quoted on CNN as saying that the MMR vaccine is as safe as a vaccine can get. Is that

correct?

Dr. MCCORMICK. Yes.

Mr. WELDON. If you were to find that the data, that the epidemiologic studies that have been quoted today—which I assume

you reviewed and that played a key role in your decisionmaking

process—correct me if I am wrong.

Dr. MCCORMICK. We were not aware of Dr. Miller’s study at the

time of the decision.

Mr. WELDON. How about the Taylor study?

Dr. MCCORMICK. Taylor, yes.

Mr. WELDON. If you were to find that any of that data was defective, would that affect your opinion on the safety of the MMR vaccine?

Dr. MCCORMICK. First, I think in terms of the statement that it

is as safe as any vaccine can be, it is made with the understanding

that all vaccines carry some degree of risk and side effects.

Mr. WELDON. Right.

Dr. MCCORMICK. We carefully looked over that epidemiologic

data twice. Not only did we have a prepared review, but both Dr.

Goodman and Dr. Gatsonis looked at that information again separately to look at the quality of that information.

I think any single study can be critiqued. It was the fact that

there were multiple studies with different kinds of designs, looking

at different populations, addressing different parts of the pie, and

all the results came out the same way. It was the consistency of

cross-studies that was impressive, not that any single study could

not have been critiqued as not having addressed all issues.

Mr. WELDON. Were you looking at their studies or their raw

data?

Dr. MCCORMICK. We were looking at the studies.

Mr. WELDON. Did you have access to the data?

Dr. MCCORMICK. No.

Mr. WELDON. The committee has asked for the data and it has

not been made available to us.

Dr. MCCORMICK. We did not have the data.

Mr. WELDON. Mr. Chairman, that is the only question I have.

Mr. BURTON. Let me just ask one or two more questions.

I have here a list of the people that were on the committee. The

University of Washington School of Medicine, Christopher Wilson— he is a professor there. Does the University of Washington School

of Medicine get any grants from any pharmaceutical companies?

Or how about Alfred Berg, University of Washington? Or Bennet

Shaywitz, Yale University? Or Gerald Medoff, professor of medicine

and microbiology at Washington University School of Medicine? Or

Columbia? Or Michigan? Or George Washington?

All those schools get grants from pharmaceutical companies,

don’t they? And don’t those people who work for those universities

that get those grants know those grants are paying for a lot of the

research they are doing?

Ms. STOIBER. Our bias and conflict of interest excludes only the

personal situation of the individual serving on the committee, their

grant support or grant support in their immediate labs. Clearly, it

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would be very difficult to compose a committee of experts if you excluded every University in the country because they receive some

grant somewhere in the university from the pharmaceutical industry.

Mr. BURTON. I understand that. But the problem is, if you are

getting a large grant from a pharmaceutical company, and you

know that your laboratory at whatever facility you are working at

or employed by is getting that grant, and you know that they have

an interest in the decision being made, don’t you think that would

wear a little bit on the processes on the people on the commission?

Ms. STOIBER. I genuinely do not. I think these individuals took

this as the very highest level of responsibility to look at the science

on its face and were not influenced by external factors of that nature. But clearly opinions could differ on that.

Mr. BURTON. Thank you.

Mr. Waxman.

Mr. WAXMAN. Dr. McCormick, a number of times during this

hearing Mr. Burton has impugned the integrity of the Institute of

Medicine’s committee. As I understand it, the committee established strict criteria for committee membership. No one with any

ties to vaccine manufacturers or their parent companies was allowed to be on the committee. No one who had ever served on a

vaccine advisory committee was allowed to be on the committee.

Even people who had provided expert testimony or had published

about vaccine safety were excluded from the committee.

Yet the chairman insists that the report is tainted by bias. He

says that after the committee wrote the report the Institute sent

it out to a panel of reviewers that contained individuals with conflicts of interest and that those individuals have biased this report.

My understanding is that reputable, published scientific findings

need to go through a review process. Is that correct?

Dr. MCCORMICK. I would defer to Ms. Stoiber, who has been answering these questions on institutional policy.

Ms. STOIBER. But I think he was asking about peer review generally.

Mr. WAXMAN. If you have a reputable, published scientific finding, doesn’t that need to go through a review process?

Dr. MCCORMICK. Absolutely.

Mr. WAXMAN. In fact, it would have been irresponsible not to

have the report reviewed. Isn’t that correct?

Dr. AMARAL. I think that is one of the safeguards of the Institute

of Medicine, that there is such an extensive review of reports.

Mr. WAXMAN. Was this review process any different from the

process of publishing an article in a peer-reviewed journal?

Dr. MCCORMICK. It is much more extensive. It is much more critical.

Mr. WAXMAN. The chairman also continues to say that the report

changed after this review process. Is this true?

Dr. MCCORMICK. There were changes of fact, there were some

changes of wording to more appropriate wording. There was no

change in the overarching conclusions of the report.

Mr. WAXMAN. Did the committee’s recommendation change after

it received the reviewer’s comments?

Dr. MCCORMICK. No.

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Mr. WAXMAN. If a parent came to you with concerns about the

safety of the MMR vaccine, after hearing all the evidence presented

to the panel and after hearing the deliberations of the panel, what

advice would you give to that parent about whether to vaccinate

their child?

Dr. MCCORMICK. I would give the advice that the child should be

vaccinated. The risks of measles far outweigh the risks for autism.

We are talking about risks of death, risks of severe chronic dementia called SSPE. These risks are real and documented as a result

of wild-type virus.

I think the risks of MMR and autism should continue to be explored, but I do not think that MMR causes even the bulk of autism. The committee did not feel they had enough information

themselves to make that kind of assessment, but that is my personal view. The risks of wild-type measles are real.

Mr. WAXMAN. I said in my opening statement that the committee

concluded that there is ‘‘no credible scientific evidence establishing

a link between the MMR vaccine and autism.’’ Is that a correct

characterization of the committee’s conclusions?

Dr. MCCORMICK. Yes.

Mr. WAXMAN. In Chairman Burton’s opening statement, he stated that ‘‘the committee found that there was insufficient evidence

to prove conclusively or disprove a connection between the MMR

vaccine and acquired autism.’’

That seems to me to be a gross mischaracterization of the committee’s findings. The committee could have chosen to say that

there was inadequate evidence, but you did not say that. You said

that the evidence favors a rejection of a causal connection between

the MMR vaccine and autism.

Why did the committee say that the evidence conflicts with the

theory that the MMR vaccine causes autism?

Dr. MCCORMICK. The theory really has not been substantiated

with a full chain of evidence. As I mentioned earlier when you were

not present, Dr. Wakefield was unable to present his full data because he was reluctant to present it in a public setting before it

was peer-reviewed. We left the door open that should such data

come in and look more solid and that there was a causal chain we

would clearly relook at the results. But it seemed to be a long way

away before that kind of causal linkage was not only established

but replicated in other laboratories.

Mr. WAXMAN. The Institute of Medicine report also states ‘‘its

conclusion does not exclude the possibility that MMR vaccine could

contribute to ASD in a small number of children.’’

Mr. Burton reads this and draws the conclusion that there is a

lot of uncertainty about the safety of the MMR vaccine. Do you

agree with this? Do you think the science raises serious questions

about the safety of MMR?

Dr. MCCORMICK. No.

Mr. WAXMAN. When I read the report, I draw a different conclusion than the chairman. We all know that it is very hard to prove

a negative. My understanding is that the Institute is saying that

it could not prove a negative. Is that correct?

Dr. MCCORMICK. That is correct.

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Mr. WAXMAN. This does not make MMR a likely cause of autism.

It does not even make the MMR theory an untested hypothesis.

Rather, the theory has been examined and all the epidemiological

evidence points toward rejection. Is that correct?

Dr. MCCORMICK. That is correct.

Mr. WAXMAN. My time is up. Thank you, Mr. Chairman.

Mr. BURTON. But you cannot say categorically that the MMR

vaccine does not cause, in any causes, autism, can you?

Dr. MCCORMICK. No, that is what the statement says.

Mr. BURTON. Thank you.

Let me just ask you two more questions.

If it is true that autistic children do not get proper medical evaluations to assess if they have gastrointestinal and immune system

disregulation, as pointed out by Dr. Wakefield, how can the IOM

committee conclude that the percentage of children with autism

caused by MMR is small?

Dr. MCCORMICK. Because the bulk of the epidemiological evidence shows no causal connection on a population basis.

In terms of the investigations Dr. Wakefield has recommended,

we, too, like Dr. Gershon, really applauded Dr. Wakefield for expanding the notions of what the problems are that these children

have.

Mr. BURTON. Dr. Weldon said to the people from England, why

don’t you just take a look at 50 or 100 or 500 kids that have autism

and gastrointestinal problems and check to see if the thesis is correct? Why not do that?

Dr. MCCORMICK. We recommended continue attention to that

and for duplication of the results in the report. That was one of the

recommendations.

Mr. BURTON. If that is one of the recommendations, that research

is necessary, why would you put out a report that everybody in the

country that was interested in this heard on television saying that

there was no causal link, period. That is all we heard. I watched

every channel and they all said the same thing, that there is no

causal link.

Yet you just said that you cannot make a categorical statement

like that.

That confuses a lot of people and it raises uncertainty even to a

higher level because people want to trust the Government and this

creates doubt.

I have one more question for you.

Since there has been a published report of vaccine-strain measles

causing encephalitis in a healthy child, why was it stated in the

IOM report that no such data existed?

Dr. MCCORMICK. We did cite it. It was found that after the primary hospitalization these children were found to have a primary

immune deficiency so that they were not previously healthy children.

Mr. BURTON. Would you give me that one more time?

Dr. MCCORMICK. After hospitalization, the patient that had this

measles-strain encephalitis was found to have a primary immune

deficiency with a decreased CD–8 count and hypogammaglobulin.

So the inflammation was thought to be due to immune deficiency.

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Mr. BURTON. So if a child has an immune deficiency, then they

are at risk for an adverse event?

Dr. MCCORMICK. Children with immune deficiency are at risk of

a wide variety of adverse effects.

Mr. BURTON. From the MMR vaccine?

Dr. MCCORMICK. Not necessarily. It depends on the nature of the

immune deficiency.

Mr. BURTON. Well, I want to thank you very much for being here.

I do want to say, though, that because this is such an epidemic,

I think our health agencies ought to look at every possible avenue,

and follow every possible avenue, to find out if this is why we have

this fantastic increase.

In Mr. Waxman’s district in California, every 3 hours there is a

new case of autism. It used to be one in every 6 hours, as you

heard earlier. Nobody seems to have any idea why.

To rule out anything and then say at the end that in some cases

it may not be conclusive when you do not have all the facts yet— you have not done a study on kid’s guts that have autism to see

if that measles vaccine is in there. It seems to me that is giving

information that is not completely factual and closing a door that

probably should not yet be closed.

Also, on the mercury vaccine—which you do not have anything

to do with—— Dr. MCCORMICK. Oh, yes, we do.

Mr. BURTON. You will be working on the thimerosal issue?

Dr. MCCORMICK. That is our next report.

Mr. BURTON. Well, I hope you will be very, very thorough and

careful when you do that report because we will have you back

here again and ask you about that. It will be a very thorough hearing once again.

And I have to tell you that in our own family—and I know there

are lot of people in this room who have autistic children and grandchildren—a normal child, nine shots in 1 day containing thimerosal

and the MMR vaccine, and 10 days later he is gone. I just have

to tell you that is really bad and we have an epidemic. We have

to find the reason why.

Mr. WAXMAN. Mr. Chairman, my observation is this: autism is an

awful disease and we have to do everything we can to fight this

disease. But when we are trying to figure out how to fight a battle,

you only have a certain amount of resources. If we take those resources and continue to go over and over and over a line that

seems to me not very promising, we have an endless task of trying

to reevaluate this theory, to try to prove whether it is a negative

or a positive. It seems to me that we ought to make some decisions

about whether we ought to be asking the scientists where we

should put the money to fight autism.

Are we going to continue to reevaluate and have another committee reevaluate Dr. Wakefield’s theory? I do not want to say that we

should ignore it. I do not know the answer. I am not a scientist.

I cannot give an answer. But I do not know that is the best place

for money to fight autism.

And I would be interested in our committee trying to find out

from scientists—I do not think scientists who disagree with Dr.

Wakefield should be treated as if they are our enemy. These are

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people from the Institute of Medicine. They have devoted their lives

to fighting disease. They are trying to fight autism.

We ought to consult with them, not challenge them. We are

doing more than challenging them, we are trying to impugn their

integrity because they have not come to the same conclusion as Dr.

Wakefield.

We can keep putting money into Dr. Wakefield’s theory over and

over and over again to where we could say, maybe it is true and

maybe it is not, instead of saying, maybe it is not but maybe it is.

It seems to me at some point we ought to ask what the best use

of money is. Should we be looking for a vaccine for autism? Should

we be looking for medicines that can cure it? Should we be doing

something to help the parents? Should we be using the money for

research in trying to find out the causes? Or do we know the

causes?

It seems like we approach this issue as if we know the cause and

there is somebody trying to keep us from keeping it open. I do not

think we know the cause and I would like us not to limit ourselves

in our thinking and our approach to this problem as if we know

this cause and what we have is a grand conspiracy to keep this

cause from being public.

I think you have done a real service, Mr. Chairman, by giving

a focus on this disease and suggesting that we need to understand

that this a problem that is serious and seems to be on the increase

and we ought to fight it. But let us not get diverted in our fight

to an endless discussion of a theory that I think is not a very promising one, from everything I have heard in the hearings, we have

had—and we have had many hearings on this one theory.

So I hope we can work together to figure out some other constructive ways to fight this disease because you and others have expressed so strongly, emotionally, and well that it is our obligation

to do that.

Mr. BURTON. Let me just end by saying that you have a great

deal of constraints on your time, Mr. Waxman, and we have had

a number of hearings. Generally, you come in and make a statement and then you leave and do not hear all the testimony and you

do not have a chance to question all the witnesses.

I understand that you have these constraints on your time. I just

hope that in the future when we have these hearings that you will

be able to devote the time necessary to hear all the witnesses instead of just coming in and making a statement and leaving.

I do not want to cause acrimony between the two of us, but that

is one of the problems. And I know you have demands on your

time.

I want to say one other thing and then——

Mr. WAXMAN. I hope you will yield to me on that point.

Mr. BURTON. I will yield to you.

Mr. WAXMAN. I do have a conflict in the time because I do not

get to set the agenda and we have other committees and other demands. But I do have staff. And I do have an opportunity to read

the testimony. And I do have a chance to evaluate what is said. I

think in doing that I have a better picture of what the different

people are saying than if I sat here and heard every single person

but refused to believe those that disagreed with my theory.

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You can sit here for hour after hour and believe that those who

say that I am right are telling the truth and those that say I am

wrong are lying. That would be maybe a good use of time, but not

a good use of process by which hearings ought to give us some conclusions.

Mr. BURTON. As I understand it, the way that you come to conclusions is you look at a whole body of people, and you see if there

is a causal link. As I understand it, you look for the commonality

of things like autism. It seems that the vast majority of the people

who are becoming autistic now—the one common link is that they

all suffered in relatively close proximity to these vaccines, a huge

percentage of them.

So there is a commonality there. So it is logical for many people—myself included—to conclude that a lot of these autistic kids

are becoming autistic because of a combination of thimerosal, the

MMR vaccine—I do not know what—but that is the commonality.

That is the thing we see.

And we have heard that week after week, month after month,

with a whole host of people testifying from around the world. Because of that, I think we need to take a very hard look and a very

thorough look at these vaccines and the contents of vaccines and

whether or not maybe separate vaccines should be given.

Instead of the MMR vaccine, maybe it should be a measles shot

without preservatives in it. Maybe it should be a single mumps

shot. Maybe a single rubella shot. I know it would be a lot more

time-consuming and more costly.

We ought to find out if we need to have mercury or thimerosal

in vaccines. As I understand it, if you have single shots, you do not

really need that kind of preservative in there and you can give a

child a shot that does not have a possible contaminant in it.

So I hope that in your review of these vaccines containing things

like thimerosal you will look very closely at that and give us a report that will be very, very thorough.

Dr. McCormick, did you have a closing comment you would like

to make?

Dr. MCCORMICK. I do not think anyone sitting around our table

is not concerned at our committee meetings about the safety of vaccines. That is why we are there. But also millions of children get

these vaccines without developing the autistic symptoms. What we

are looking at in the epidemiologic literature is the comparison of

those with the vaccine and without to see to what extent we can

draw the association with autism.

So that information does not support the linkage. But I do not

think there is anybody sitting around our committee table that is

not concerned about the safety of vaccines and is not coming to it

from a neutral point of view that if they saw a risk they would not

call it.

Mr. BURTON. I understand and I appreciate your comment.

But I will tell you this: it used to be 1 in 10,000 and in Indiana

it is 1 in 400, and in Oregon it is 1 in 190 kids that are autistic.

There has to be a cause and it appears as though one of the contributing factors are some of these vaccines.

With that, thank you very much for being here. We stand adjourned.

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[Whereupon, at 3:15 p.m., the committee was adjourned to reconvene at the call of the Chair.]

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AUTISM—WHY THE INCREASED RATES? A

ONE-YEAR UPDATE

THURSDAY, APRIL 26, 2001

HOUSE OF REPRESENTATIVES, COMMITTEE ON GOVERNMENT REFORM, Washington, DC.

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

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

of the committee) presiding.

Present: Representatives Burton, Gilman, Morella, McHugh,

Weldon, Waxman, and Cummings.

Staff present: David A. Kass, deputy counsel and parliamentarian; Mark Corallo, director of communications; S. Elizabeth

Clay, professional staff member; Robert A. Briggs, chief clerk; Michael Canty, legislative assistant; John Sare, deputy chief clerk;

Corinne Zaccagnini, systems administrator; Kate Anderson, Jon

Bouker, and Sarah Despres, minority counsels; Ellen Rayner, minority chief clerk; and Teresa Coufal, minority staff assistant.

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

The minority ranking member will be here shortly, as will some

of the other panelists. I ask unanimous consent that all Members’

and witnesses’ opening and written statements be included in the

record. Without objection, so ordered.

I ask unanimous consent that all articles, exhibits and extraneous or tabular material be included in the record. And without

objection, so ordered.

We’re going to be hearing today from the National Institutes of

Health, the Centers for Disease Control and Prevention and the

Food and Drug Administration. Autism is a neurobiological disorder. It locks a person inside himself or herself. This disorder,

which leaves children like my grandson, Christian, unable to express themselves or interact with others, is now at epidemic levels

in this country, and I mean epidemic.

One in 400 children in Indiana, 1 in 190 children in Oregon, 1

in 150 children in Brink Township, NJ. How has the Department

of Health and Human Services responded to this epidemic? Have

our health agencies recognized this dramatic rise and acted accordingly? If we generously estimate that NIH has focused $60 million

on autism, and that’s generous, autism research out of a $20 billion

budget, that would mean that their investment is 0.003, three

thousandths of 1 percent.

Does that adequately address an epidemic that affects between

1 in 190 children in Oregon and 1 in 500 children nationwide? I’m

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including in the record a document taken from the NIH Web site

this morning that shows research initiatives at the NIH and their

funding for a 3-year period. We’ll give you all copies of this, we’d

like for you to take that back with you. According to this document, NIH estimates they will spend $45 million this year on autism. This is compared to $136 million on

sleep disorders and $434 million on vaccine development, which

could be part of the problem, especially if it’s got mercury in it.

Two of the issues that were discussed at length yesterday were the

concerns that the dramatic rise in autism may be related to the

MMR vaccine and mercury exposure through childhood vaccines.

We do not yet have enough research evidence to make a conclusion

one way or the other. Our health agencies need to fund clinical and

laboratory research that will get the answers.

As we learned yesterday, epidemiological studies cannot answer

these questions. Epidemiology is important for looking at incidence

and prevalence, but not in answering questions about causality. I

have a short video showing the effects of mercury on the brain. I

think that’s simply saying that we’re moving to get new vaccines

on the market that have little or no mercury. It’s a step in the

right direction, but I continue to be concerned on behalf of the

8,000 children a day who may be exposed to mercury through their

childhood vaccines until the current supply is used up.

And why that isn’t being recalled by the health agencies of this

country, the FDA, I cannot fathom. As we speak, kids are having

mercury shot into their arms, and we know it’s a toxic substance.

We had toxicology experts here yesterday talking about it and what

it does to the brain. We’re going to show a video on what it does

to the brain.

And yet the people in the health agencies continue to allow that

to be done. And I cannot figure out why.

Yesterday we also heard about research that the NIH is funding

at the University of Rochester regarding mercury in autistic children. We’ll hear today how research is to evaluate the level of mercury in the serum, the hair and the urine of children receiving the

currently recommended childhood immunization schedule.

I hope that the reports will include the hair and urine data as

Dr. Haley, a leading mercury expert, suggested. Simply reporting

the blood data will be misleading. To only report the blood data

and not analyze and report the hair and urine samples would be

an injustice. We need to look at it all.

And I want to tell you something. We have 113 Members of Congress that have signed up for the Autism Caucus. We’re going to

end up with about 270, 280. And we’re probably going to have over

half the U.S. Senate in the caucus. And if you think this is going

to go away, you guys are blowing smoke. Because I’m telling you,

I’m going to make sure that everybody in the Congress knows the

problems and knows what’s facing us. If the health agencies don’t

deal with this and deal with it quickly, you’re going to have a big

problem over there.

I’ve also talked to Tommy Thompson, new head of the Health Department. He’s going to continue to talk to you, on a regular basis,

if we don’t do something about this. It’s unconscionable that we

have thousands and thousands of children being inoculated and

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vaccinated with vaccines that have toxic substances in them, and

we see a horrible increase in the number of people that are autistic

and we continue down the same path.

I just don’t understand it. Last year the Centers for Disease Control and Prevention reported that they did not know why so many

children in Brick Township, NJ, had autism. They conducted a

thorough evaluation of environmental toxins and numerous other

potential factors, but chose not to include vaccine history as a part

of their evaluation and report. Why is this?

I believe vaccines are so important, but why they put three and

four and five and six and seven and eight and nine together at one

time, with mercury and other toxic chemicals in them into our kids,

I just don’t understand. We have an epidemic on our hands, and

we cannot ignore any potential path that may lead to ending the

epidemic.

With that, we have this brief video that we’d like for you to see

that shows the effects of mercury on the brain and I hope you’ll pay

particular attention to this.

[Video shown.]

Mr. BURTON. That test was done in June 1999, almost 2 years

ago. I don’t know if our health agencies are aware of it, but in your

comments today, I hope you’ll address whether or not you’re familiar with that study, and whether or not our health agencies have

done like studies or taken an interest in that and can respond to

it.

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

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Mr. BURTON. Do you have an opening statement, Mr. Gilman?

Mr. GILMAN. I want to commend the chairman and our committee for looking into this problem, one that’s long overdue, and I

thank you for the opportunity to be here.

Mr. BURTON. Thank you, Mr. Gilman. I don’t know if you’re familiar, but Congressman Chris Smith and Congressman Doyle

have formed what’s known as the Autism Caucus. I don’t know if

you’re a member yet, but I hope you will join so we can make sure

every member is aware of the problems with it.

Let’s start with Dr. Rennert. Do you have an opening statement?

STATEMENTS OF OWEN M. RENNERT, M.D., SCIENTIFIC DIRECTOR, NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN

DEVELOPMENT, NATIONAL INSTITUTES OF HEALTH; KAREN

MIDTHUN, M.D., DIRECTOR, OFFICE OF VACCINE RESEARCH

AND REVIEW, FOOD AND DRUG ADMINISTRATION, ACCOMPANIED BY SUSAN ELLENBERG, M.D., DIRECTOR, OFFICE OF

VITAL STATISTICS AND EPIDEMIOLOGY; NORMAN BAYLOR,

M.D., ASSOCIATE DIRECTOR, REGULATORY POLICY, OFFICE

OF VACCINES; AND DR. COLLEEN BOYLE, ACTING ASSOCIATE DIRECTOR, SCIENCE AND PUBLIC HEALTH, CENTER ON

BIRTH DEFECTS AND DEVELOPMENTAL DISABILITIES, CENTERS FOR DISEASE CONTROL AND PREVENTION

Dr. RENNERT. Mr. Chairman and members of the committee, I’m

Dr. Owen Rennert, Scientific Director of the National Institutes of

Child Health and Human Development at the NIH. I appreciate

the opportunity to provide information on behalf of the NIH Autism

Coordinating Committee about ongoing and planned research activities at the NIH that are relevant to autism and pervasive developmental disorders.

Autism, as you know better than I, is a cruel disorder, not only

as a result of the disability it causes, but also because it is an illness that challenges the emotional bond between child and parent.

In its most severe forms, it effectively isolates that child socially,

cognitively, emotionally and linguistically, denying other family

members even the opportunity to console and comfort.

In light of these immense human costs and the significant public

health burden that autism brings with it, the NIH is working to

focus the research community with ever-greater intensity on this

terrible disease. We appreciate the continued involvement that parents have given us in that effort.

The Children’s Health Act of 2000 called for expansion, intensification and coordination of autism related scientific programs at

NIH. I’m pleased to report that significant progress is being made,

including toward the establishment of a new network of centers of

excellence in autism. The act directed the Secretary of Health and

Human Services to establish an interagency autism coordinating

committee, which will include NIH, the Centers for Disease Control

and Prevention and other HHS agencies.

Yesterday, Secretary Thompson delegated to NIH authority for

establishing this coordinating committee. And we can assure you,

it will have at least three members from the parent community of

children with autism.

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There has been considerable expansion and enhanced coordination of autism research efforts at NIH. The amount of NIH support

autism related research grew from $22 million in fiscal year 1997

to $52 million in fiscal year 2000. This demonstrates the commitment of Institute members to the broad intensification of autism

research efforts.

As you requested, Mr. Chairman, we have supplied for the record

the 10-year funding history of NIH sponsored autism related research, the list of projects funded in fiscal year 2000. We will also

be supplying the abstracts of those funded grants shortly.

Effective this week also, NIH has released an RFA, request for

applications, containing setaside funds for research support for the

development of autism centers applications. This is part of an overall plan to support a variety of investigative teams and wherever

possible, to recruit the participation of outstanding investigators

who previously have not worked in autism research. These grants

would be funded in September 2001 if meritorious applications are

submitted.

A second RFA will be issued in fiscal year 2002 to solicit applications for the centers of excellence with funding of the first of these

centers targeted for early in fiscal year 2003. NIH anticipates a

pool of approximately $8 million per year, which will be available

for the first 5 years of the funding of those programs.

The Children’s Health Act of 2000 calls upon NIMH, the Institute of Mental Health, to take the lead in providing a program

under which samples of tissues and genetic materials are donated,

collected, preserved and made available for autism research. NIH

presently supports ongoing efforts by Harvard’s brain tissue resource center, UCLA and the University of Miami’s tissue banks,

and recently special supplements were awarded to target acquisition of necessarily biological materials from individual with autism

for focused study.

The network. In 1997 through an RFA, the National Institutes

of Child Health and Human Development with co-funding from the

National Institute of Deafness and Communicative Disorders, established the networks on the neural biology and genetics of autism, referred to as the collaborative programs of excellence in autism.

Currently, we have enrolled nearly 2,300 patients with well diagnosed autism in the network and are gathering data from their

families. A major ongoing CPEA initiative, a part of this network

that is co-funded by NICHD, NIDCD and the CDC is the autism

regression vaccine study. A principal goal of this study is to assess

temporal association between measles, mumps, rubella vaccine and

the onset of autism and attempts to differentiate early and late

onset forms of the disorder.

Another aim of this study is to try to replicate studies of persistent measles infection in children with autism versus those children

who are not affected. Stage one of the project, which got underway

in September 2000, includes 1,600 well diagnosed cases of autism

and 1,250 healthy controls. Individual vaccination records as well

as records of the onset of autism, specifically looking at the age of

onset, the age of recognition and the age of the diagnosis, will be

examined in this study.

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Stage two of this project will attempt to replicate previously reported findings regarding abnormal measles antibody titers and

persistent measles infection. In this phase, investigators will examine 250 children with early onset autism, 250 children with the regressive form of autism, 250 healthy controls matched to early

onset cases, as well as 250 controls matched to regressive autism

cases.

Neuroscience research, as you know, requires that we understand the pathogenesis and cause of autism, and is the most promising approach to ultimately developing targeted effective treatments. Until the brain mechanisms responsible for the manifestations of autism are understood, it will not be possible to develop

truly targeted interventions.

Treatment research also is currently focused on studying the efficacy and safety of promising treatment interventions which are

commonly used in the community without adequate testing or are

aimed at specific impairing symptoms. These include both psychosocial and pharmacologic interventions.

Last October, neuroscientists, including autism researchers, parents, advocates and NIH program staff, participated in a 1-day

brainstorming session on the role of the environment in autism

which was organized by the National Institutes of Environmental

Health Sciences. This group identified key priorities, large scale

epidemiologic studies to determine autism incidence and prevalence

trends, studies to describe the natural history of autism and to

identify meaningful subgroups that may be at increased risk from

environmental exposures in studies specifically to examine the proposed association between regressive autism and thimerosal in vaccines.

Mr. BURTON. I don’t know how much longer your opening statement is, but we’d like to get to the questions as quickly as possible.

Dr. RENNERT. I’ll abbreviate it.

I simply would indicate to you that there are ongoing studies of

several institutes amongst the ones you mentioned, the one at the

University of Rochester, which attempt to look at hair, urine,

serum levels of children having received a thimerosal and mercury

derivatives, of children having received immunizations, those who

have had thimerosal containing vaccines and those who haven’t.

Preliminary data, as you were told yesterday, shows no difference in blood levels. I do not have at this point in time the complete analysis, because it hasn’t been completed.

There are also studies at several centers that are looking at the

pharmacokinetics, the metabolism, the disposition and the disposition in tissues such as brain of mercury when administered as thimerosal, mercurial mercury in monkeys. There are another set of

studies that have been funded in November 2000 that are carrying

out somewhat similar experiments in rats. These again look at the

cellular distribution patterns of mercury in tissue, including the

brain, and also are attempting to evaluate the role of immune activation in altering brain levels of mercury after exposure to thimerosal.

The last comment that I’ll make in a general way is that as you

know, the Children’s Health Act authorized a longitudinal study to

investigate basic mechanisms of environmental disorders and enviVerDate 11-MAY-2000 09:23 Feb 22, 2002 Jkt 000000 PO 00000 Frm 00320 Fmt 6601 Sfmt 6601 C:\DOCS\76856.TXT HGOVREF1 PsN: HGOVREF1
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ronmental factors, both risk and protective, that influence health

and developmental processes.

In the context of environment, one is talking about chemical,

physical, social behavioral influences on children who have critical

windows of vulnerability during development, during which time

environmental exposures could have a greater influence and diseases of increasing prevalence, such as autism and asthma, are two

targeted elements of this. Planning for this study, which will follow

about 100,000 children across the United States from birth into

adulthood, is currently underway, with pilot studies scheduled to

occur in fiscal year 2002.

The other comments I was going to make related exclusively to

the efforts of the NIH to increase its dialog with the parents and

the public community with regard to what our priorities should be,

how we conduct our research as it relates specifically to autism.

The only thing to highlight there is as a consequence of those efforts, there is a list server presently available that provides up to

date information about autism related research activities at the

NIH, there is an NIH Web page which also allows you to identify

all the research that presently is funded by NIH and gives you information about advocacy groups, the scientific literature, etc.

In closing, we at NIH understand the passion of parents and

families of those who have been affected by autism and related disorders and share your concerns for quickly unraveling the mystery

of autism. Thank you, Mr. Chairman.

[The prepared statement of Dr. Rennert follows:]

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Mr. BURTON. Dr. Midthun.

Dr. MIDTHUN. Mr. Chairman and members of the committee, I’m

Dr. Karen Midthun. I’m the Director, Office of Vaccine Research

and Review of the Center for Biologics Evaluation and Research,

FDA. With me today are Dr. Susan Ellenberg and Dr. Norman

Baylor. Dr. Susan Ellenberg is Director of the Office of Vital Statistics and Epidemiology, and Dr. Norman Baylor is the Associate Director for Regulatory Policy in the Office of Vaccines.

Mr. Chairman, as a physician and a parent, I want to express

to you, the members of this committee and to parents that I’m

aware of the devastating effects of autism on children and their

families. I’m here to assure you that we are working diligently to

ensure that the vaccines we license for use in the United States are

shown to be safe, pure and potent. I appreciate the opportunity to

participate in this hearing on autism and to respond to the committee’s concerns regarding a potential link between vaccines and autism.

The Office of Vaccines regulates the investigation and licensure

of vaccines. FDA’s regulatory process for licensing vaccines has for

decades served as a model for other countries. To date, the existing

data do not demonstrate a causal relationship between vaccines

and autism. However, I want to assure this committee, the public

and especially parents that FDA takes these concerns seriously.

One concern that has been raised relates to the use of thimerosal, a mercury compound as a preservative in some vaccines. FDA

recognizes and supports the goal of reducing exposure to mercury

from all sources. Consistent with this goal, for several years, FDA

has encouraged manufacturers to develop new vaccines without thimerosal as a preservative, and to remove or reduce the thimerosal

content of existing licensed vaccines.

Initial results of this effort were realized at least a year prior to

the enactment of the FDA Modernization Act of 1997, with the licensure of new thimerosal-free vaccines. As required by Section 413

of FDAMA, FDA conducted a review of the use of thimerosal in

childhood vaccines. A review revealed no evidence of harm caused

by thimerosal used as a preservative in vaccines except for local

hypersensitivity reactions.

Under the U.S. recommended childhood immunization schedule,

the maximum cumulative exposure to mercury from thimerosal at

the time of this review in 1999 was within acceptable limits for the

methyl mercury exposure set by FDA, the Agency for Toxic Substances and Disease Registry and the World Health Organization.

Of note, all these guidelines contain a safety margin and are meant

as a starting point for evaluation of mercury exposure, not absolute

levels above which toxicity can be expected to occur.

However, during the first 6 months of life, cumulative exposure

to mercury in some cases could have exceeded the more conservative limits of the EPA depending on the specific vaccine formulations used and weight of the infant. The clinical significance of exceeding EPA’s limits is not currently known. Nevertheless, reducing exposure to mercury from vaccines is warranted and achievable, in part because in the United States, it is possible to replace

multi-dose vials with single dose vials, which do not require a preservative.

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I am pleased to be able to report substantial progress in the efforts to reduce thimerosal exposure from vaccines. At this time, all

routinely recommended licensed pediatric vaccines being manufactured for the U.S. market contain no thimerosal or contain only

trace amounts in the final formulation. Prior to the recent initiatives to reduce or eliminate thimerosal from childhood vaccines, the

maximum cumulative exposure to mercury by routine childhood

immunizations during the first 6 months of life was 187 and a half

micrograms. With the newly formulated vaccines, the maximum cumulative exposure during the first 6 months of life will now be less

than 3 micrograms of mercury, more than a 98 percent reduction.

In an effort to better characterize any toxicity that could have accompanied an exposure to thimerosal from vaccines, FDA is in the

process of nominating thimerosal to the National Toxicology Program for further study.

Reports of developmental delay following vaccination have been

submitted to the Vaccine Adverse Event Reporting System

[VAERS]. Although VAERS reports by themselves usually cannot

establish a causal relationship between a vaccine and an adverse

outcome occurring after vaccination, further study of these reports

can sometimes provide important clues and suggest directions for

further research.

FDA takes these reports seriously and has begun a followup

study of VAERS reports of autism. In addition, FDA is pursuing research involving the characterization and development of an animal model for autism. While looking at ways to improve the safety

of vaccines, we must keep in mind that childhood vaccines have

contributed to a great reduction in vaccine preventable diseases, including polio, measles and whooping cough.

Today, it is rare for American children to experience the devastating effects of vaccine preventable illness. However, vaccines,

like all medical products, are not risk free, and FDA is committed

to continuing its efforts to reduce these risks whenever possible.

In conclusion, FDA continues to work diligently with manufacturers to eliminate or reduce exposure to mercury from thimerosal

in vaccines. As stated previously, at this time, all routinely recommended licensed pediatric vaccines being manufactured for the

U.S. market contain no thimerosal or contain only trace amounts

in the final formulation.

Although no causal relationship between vaccines and autism

has been established, FDA, along with other Health and Human

Service agencies, continues to pursue research activities to increase

our understanding of any potential relationship between vaccines

and neurodevelopmental disorders. Although the prevention of disease through the use of vaccines is a tremendous public health accomplishment, there is more work to be done. I assure you that the

Office of Vaccines at FDA will continue to make regulatory decisions or recommendations regarding vaccines based on the best scientific evidence to protect the public health.

Mr. Chairman, I appreciate the committee’s interest in this area,

and look forward to continuing to work with you on this in the future.

[The prepared statement of Dr. Midthun follows:]

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Mr. BURTON. Thank you.

Dr. Boyle.

Dr. BOYLE. Good morning, Mr. Chairman and members of the

committee. I’m Dr. Colleen Boyle, Acting Associate Director for

Science and Public Health in the newly established Center on Birth

Defects and Developmental Disabilities at the Centers for Disease

Control and Prevention.

I have with me today Dr. Roger Bernier, an epidemiologist and

Associate Director of Science for the National Immunization Program at the CDC.

Thank you for the opportunity to update you on CDC’s activities

related to autism. One major change since last year is that CDC

has established, at the direction of Congress, a new center, the National Center for Birth Defects and Developmental Disabilities.

This center will increase CDC’s efforts to discover causes and develop preventive strategies for birth defects and developmental disabilities, including autism.

First, Mr. Chairman, I want to stress that CDC is committed to

understanding the prevalence of autism, identifying its preventable

causes and establishing and evaluating prevention programs. We’ve

made considerable progress over the last year toward fulfilling this

commitment. Last year, we mentioned that CDC and the Agency

for Toxic Substances and Disease Registry were about to report on

an investigation on the prevalence of autism in Brick Township,

NJ. The investigation found a rate in Brick that is high compared

to many previous studies.

However, there are few very recent studies, none in the United

States, that have reported rates in this range, which suggest that

the rate of autism may be considerably higher than previously

thought. To increase our ability to monitor autism prevalence in

the United States, in September 2000, CDC competitively funded

health departments in Arizona, South Carolina, Maryland and New

Jersey to establish monitoring programs for autism in their States.

CDC is also completing the analysis of the first year of autism

monitoring data gathered from its own metropolitan Atlanta developmental disability surveillance program. Our report should be

complete later this year.

This September, as directed by Congress, CDC will competitively

fund up to four centers of excellence in autism epidemiology to conduct collaborative epidemiologic studies. The research objectives of

these studies will be determined by an independent oversight committee, and representatives from parent and consumer groups will

be invited to provide input to the oversight committee in planning

the epidemiologic study.

CDC has also developed a wide range of activities that are responsive to the needs of parents of children with autism and health

care professionals working with these children. For example, CDC

funds a program at Marshall University in West Virginia of an intensive community support program for families with young children with autism. As part of the centers for excellence in autism

and epidemiology, we expect to fund projects of model intervention

programs for children with autism, of the economic and social costs

of autism, and of studies to look at the natural history of autism.

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Some parents have expressed concern about the potential link

between autism and vaccines. Although the weight of the scientific

evidence does not support such a link, CDC is committed strongly

to assuring vaccine safety. The concerns raised regarding autism

and vaccines have focused primarily on thimerosal, a preservative

in some vaccines, and on the measles, mumps and rubella vaccine.

Today, all manufacturers are producing for immunization only vaccines that are free of thimerosal or have only trace elements of thimerosal.

As shown in figure one of my testimony, the thimerosal content

of pediatric vaccines purchased by States through CDC’s contract

has dramatically decreased since 1998. CDC is actively investigating whether there have been any adverse effects related to thimerosal in vaccines. Preliminary analyses of the vaccine safety data link

have not supported a link between thimerosal containing vaccines

and autism.

It has been suggested that vaccination, particularly with the

MMR vaccine, may be related to the development of autism. Substantial scientific review does not support this suggestion. First,

the American Academy of Pediatrics executive committee stated in

March 2001 that there is a considerable body of evidence that does

not support a causal relationship between MMR vaccine and autism or inflammatory bowel disease. Second, the IOM stated just

this week that existing evidence does not favor a causal relationship between the MMR vaccine and autism.

In addition, Dales et al. recently reviewed changes over time in

the MMR coverage and autism diagnoses in California. There was

a 373 percent relative increase, in the prevalence rate of autism between 1980 and 1994 while the MMR immunization coverage was

relatively flat over that same period.

To date, the weight of the scientific evidence does not support a

causal relationship between vaccines and autism. Nevertheless, because of the continuing concern of parents, we are committed to

conducting research to evaluate this matter. At present, we are

conducting a study in Atlanta, another in Denmark, and we are

collaborating with NIH, with their centers and programs of excellence in autism to further examine the relationship between vaccines and autism.

While we must remain vigilant to assure the safety of vaccines,

we must also remember that vaccines benefit the individual child

and the public by protecting persons from the consequences of infectious diseases. While we’ve made great progress to reduce the

number of cases of vaccine preventable diseases, threats posed by

vaccine preventable diseases are known and are real.

We want to assure you that CDC knows how important it is to

find the causes of autism and prevent this disorders. We are committed to conducting research that will lead to these answers. With

the support of Congress, we have made a good beginning by funding autism monitoring programs with several States and the Centers of Excellence in Autism Epidemiology to look at causes of autism. CDC’s efforts will continue until we have found the answers

that will enable us to prevent this serious condition that affects so

many American children.

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Thank you, Mr. Chairman and members of the committee, for

the opportunity to testify before you today. Dr. Bernier and I would

be happy to answer any questions that you may have.

[The prepared statement of Dr. Boyle follows:]

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Mr. BURTON. I neglected to have you sworn. Would you all please

stand?

[Witnesses sworn.]

Mr. BURTON. Dr. Boyle, why is it that there’s a reduction in thimerosal in vaccines that are being produced today? Did not our

health agencies request that thimerosal be removed from vaccines

as the newly produced vaccines?

Dr. BOYLE. I think we’ve made considerable progress in reducing

the thimerosal content.

Mr. BURTON. So you’ve asked that thimerosal be reduced in vaccines, have you not?

Mr. BERNIER. I think the answer is that this was done as a precautionary measure.

Mr. BURTON. Why?

Mr. BERNIER. Because it was feasible to do, and there are sources

of exposure to mercury that we cannot control, such as that from

food. So—— Mr. BURTON. I’m talking about the vaccine. Why is it that you

have started at our health agencies to reduce the amount of thimerosal in vaccines, as a precautionary measure?

Mr. BERNIER. As a precautionary measure.

Mr. BURTON. OK, as a precautionary measure. That would lead

one to believe that you’re not really sure whether or not thimerosal

causes some problems. Otherwise, why wouldn’t you just leave it

in there and say, hey, we’ve run all these tests, there’s no causal

link whatsoever? So why even move to take it out of there?

Mr. BERNIER. There is a theoretical risk.

Mr. BURTON. OK, so there’s a theoretical risk. Then why have we

not recalled the vaccines that have thimerosal in them right now,

while you’re testing this? If there’s any question whatsoever about

what we’re putting into our kids’ arms, and their bodies, and if

you’re reducing thimerosal because you think there may be a causal link, as a precautionary measure, why don’t you recall the thimerosal that’s in doctors’ offices that are being injected into kids

as we speak until you’re sure? Because obviously you’re not sure

or you wouldn’t be taking it out anyway. Why don’t you recall it?

Mr. BERNIER. I can give you my comments. The FDA may wish

to weigh in on this issue of recall. But as succinctly as I can put

it, Mr. Chairman, being safe means being safe from disease as well

as being safe from the side effects of vaccine.

Mr. BURTON. Let me ask you this question, then. Can you create

a measles vaccine and do we have a measles vaccine that does not

have thimerosal in it?

Mr. BERNIER. Yes, that’s correct.

Mr. BURTON. Can we create a mumps vaccine that does not have

thimerosal in it?

Mr. BERNIER. That’s correct.

Mr. BURTON. Then why are you putting thimerosal in it?

Mr. BERNIER. At the present time, as Dr. Midthun and Dr. Boyle

mentioned, we have made very good progress, and I can say to you

we are not putting in thimerosal any longer in the vaccines that

are being produced.

Mr. BURTON. So if you’re not, if you’re not, as a precautionary

measure, then why are you leaving vaccines on doctors’ shelves and

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in drugstores around this country that are being used in facilities

where they supply them, are being used, if you’re not putting them

in new vaccines, as a precautionary measure? Why don’t you recall

the supply that you have out there until you are absolutely sure,

beyond any doubt, that thimerosal has no causal link to autism?

Why don’t you recall it?

Dr. Midthun.

Dr. MIDTHUN. Under the Public Health Service Act, in order to

make a mandatory recall of vaccine, there has to be an imminent

or substantial hazard to the public health. As the weight of the evidence does not support a causal link between thimerosal—— Mr. BURTON. Then why are you taking it out of the new ones?

Dr. MIDTHUN. As Dr. Bernier said, it’s a precautionary measure.

It’s recognized that mercury in large doses is toxic and any way

that we have of reducing the exposure to mercury over which we

have control is something that is desirable to do.

Mr. BURTON. Let me tell you, my grandson was very healthy and

very normal and spoke and ran around like every other child. He

got nine vaccines in 1 day. He got 41 times what’s the allowable

amount of mercury through thimerosal in 1 day. And 10 days later,

we lost him. Now, we’re trying to get him back.

Now, there’s a lot of parents out there that are getting all these

shots when their children’s immune systems are depressed, they’ve

got colds, and they’re getting these shots, several of them at a time,

with thimerosal in them. As a precautionary measure, if you think

there may be a causal link, don’t you have any latitude whatsoever

to recall those and say, we’re not going to destroy this, but we’re

going to hold these supplies in abeyance until we know for sure,

until all the tests have been done?

Dr. MIDTHUN. Not under the Public Health Service Act. That’s

not what would allow us to make a mandatory recall.

Mr. BURTON. But you are taking thimerosal out of vaccines, as

a precautionary measure?

Dr. MIDTHUN. That’s correct.

Mr. BURTON. How long are these studies going to take, Dr.

Rennert?

Dr. RENNERT. We hope to have answers of various phases within

the next 2 to 3 years.

Mr. BURTON. Oh. Do you know how many kids are going to be

vaccinated today? Do you know that in California, it used to be one

child every 6 hours was becoming autistic. It’s now one every 3

hours. In the United States, 1 out of 400 to 500 kids are autistic.

And in some parts of the country, it’s under 200. And boys have

a four times more prevalence of getting autism than girls.

So if you go to Oregon, 1 out of 190 kids are autistic, that means

1 out of 50 boys being born are going to be autistic. And you’re telling me these studies are going to take 2 to 3 years, and at the

same time the studies are going to take 2 to 3 years, you’re going

to keep mercury in vaccines that you just saw from that Calgary,

Canada study what mercury does to brain cells?

I mean, come on. If there’s any doubt whatsoever, and you say

it’s a precautionary measure you’re taking, then why in the heck

don’t you get that stuff off the market until you’ve tested it thoroughly? And if it’s going to take 3 years, put it some place for 3

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years, in a storage box, and if the tests don’t prove out, you’ve still

got it, and the pharmaceutical companies can still get their money.

Now, on these tests that you’re doing, you said you’re testing the

blood for mercury. Are you testing hair and urine samples?

Dr. RENNERT. Yes. In the studies that were done by Navy and

the University of Rochester, there are samples that have been obtained for study of hair and urine concentrations as well.

Mr. BURTON. Have you had any results from that yet?

Dr. RENNERT. No, sir. The study as far as I know has just been

completed and the analysis is occurring. I don’t have the data.

Mr. BURTON. How long will it take to get that analysis?

Dr. RENNERT. I would imagine—to be honest, sir, I don’t know.

I don’t think it will be long, but I will attempt to find out and give

you an answer.

Mr. BURTON. We would like to have copies of the analysis as

quickly as you get them. We’d like to have any records that you

have whatsoever about the analyzing of blood, hair, urine, whatever it is, regarding mercury and thimerosal in these kids.

You know, you were talking about how vaccines have reduced

measles, mumps, rubella, diphtheria, all these other things. And

that is great. And we really appreciate what vaccines and pharmaceutical companies have done for this country. Because they’ve

saved a lot of lives. And what you’ve done has been very laudable.

But when you have a child who is autistic, from the time he becomes autistic until he dies, they estimate that the cost to our society is $5 million, for each child. Now, if we have 1 in 400, and the

cases are rising at a very rapid rate, do you have any idea what

that’s going to do to our economy? Not now, but 5, 10, 15, 20 years

from now. And so every precaution that should be taken must be

taken and must be taken now. Because this is not only a health

issue, it’s an economic issue that’s not going to go away.

I mean, we’re talking about trillions and trillions of dollars if we

don’t find an answer. If you’ve got substances, aluminum, formaldehyde, mercury, in these vaccines, and you have this huge rise and

you’re not absolutely sure that mercury’s not causing it, you ought

to get it out of there. You ought to recall this stuff. Because the

doctor just said, Dr. Bernier just said that they are producing and

can produce vaccines without mercury in them, without thimerosal.

Now, granted, you might not be able to put three or four different vaccines in one vial. Because as I understand it, you put the

mercury in there to keep everything pure so they can be used, and

won’t be tainted. But if you go to single vials with single vaccines,

sure, the parents would have to have more shots. But if it’s going

to be safer, then why not do it? And why wait 3 years for studies

if you think that there may, even the most remote possibility, be

a causal link.

If you look at some of these studies, like we’ve seen, and I am

not a scientist, I’m not a doctor, I’m just a grandfather who has an

autistic kid, and I didn’t even know what autism was until a couple

of years ago. But when you see the huge number of people that are

contacting us through e-mail and through conferences, there’s one

going on right here, you’ve got to take the proper precautions. You

can’t say, let’s wait 3 years and let this go on.

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So as I said earlier, and I’m going to yield to my colleagues here,

as I said earlier, we have 113 members in the Autism Caucus.

They will be supplied with every bit of information we get, not only

from you folks, but from Calgary, Canada, and from around the

world and from the experts we have here. And I will be taking special orders on the floor of the House. I’ll be going down there on

a regular basis, reading into the record and talking to the American people, about the problems that we have.

So the pressure that you’re feeling, if any, now, I don’t know if

you are or not, but the pressure you’re feeling right now is going

to be magnified as many times as I can make it, until our health

agencies either come to some conclusion that’s scientifically provable, or they get that stuff out of there, in particular thimerosal.

And I don’t know why, if you’re coming up with vaccines that don’t

have these toxic substances in them, as I believe they are, I don’t

understand why you don’t recall that stuff. Get it off the market.

FDA, can you do a voluntary recall for manufacturers the same

as the rotavirus recall?

Dr. MIDTHUN. That was not a voluntary recall. The manufacturer

on their own initiative withdrew their product from the market.

Mr. BURTON. Can you contact the people that manufacture thimerosal, and I know who it is, can you ask them to recall it temporarily?

Dr. MIDTHUN. That would be something that would be voluntary

on their basis.

Mr. BURTON. You can’t write them a letter and say that because

of the concern of thousands and thousands of parents and because

we’re in the process of doing research on this, we think it would

be prudent to recall thimerosal products until we run all of our

tests, which may take as much as 3 years?

Dr. MIDTHUN. I’m sure that the companies are well aware also

of these concerns over autism——

Mr. BURTON. But you can’t even write them a letter?

Dr. MIDTHUN. It’s their choice to make a voluntary recall, and

they know that they have that choice, sir.

Mr. BURTON. So you’re not going to do anything?

Dr. MIDTHUN. Under the PHS Act, we can make a mandatory recall for the reasons that I indicated. And the company, of course,

on its own volition, can do anything it would like in terms of making product available or deciding not to distribute it any longer.

Mr. BURTON. I found out yesterday that there’s a lawsuits pending, I believe in, I think it’s Mississippi, regarding mercury toxicity

and how it’s affected children. And if that lawsuit is successful by

the people who are bringing the suit, it will probably involve a

great deal of money to the pharmaceutical company that produces

this product, and other pharmaceutical companies that use it in

their vaccines.

I wonder, I just wonder if perhaps one of the reasons why FDA

is not pounding these pharmaceutical companies to get this off of

the market, especially when you look at this Calgary study about

mercury and the toxicity of it, maybe there’s not pressure being exerted by pharmaceutical companies on our health agencies because

they’re afraid of what might happen in that lawsuit if they do withVerDate 11-MAY-2000 09:23 Feb 22, 2002 Jkt 000000 PO 00000 Frm 00380 Fmt 6601 Sfmt 6601 C:\DOCS\76856.TXT HGOVREF1 PsN: HGOVREF1
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draw it from the market. Is there any validity to that kind of

thinking?

Dr. MIDTHUN. I really couldn’t say. I do not know, sir.

Mr. BURTON. OK, Mr. Gilman.

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

raising these issues.

Permit me to request that my opening statement be made part

of the record.

Mr. BURTON. Without objection.

[The prepared statement of Hon. Benjamin A. Gilman follows:]

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Mr. GILMAN. And I do have several questions. I think what

Chairman Burton is raising I think is quite pertinent. I’m surprised to hear that, Dr. Midthun, you’re reluctant to issue any letter to the manufacturers if there is some concern. You say there

is some mandate in the legislation that permits you to make some

of these corrections?

Dr. MIDTHUN. Under the PHS Act, the FDA can make a mandatory recall if there is an imminent or substantial hazard to the

public health. And as I noted before, the preponderance of the evidence does not suggest that there was a causal relationship between thimerosal containing vaccines and autism. Thus, there is no

substantial or imminent hazard that would authorize us to make

a mandatory recall, sir.

Mr. GILMAN. And yet, you are making a request that the thimerosal not be included in the future production of vaccines because

of some concern? Is that correct?

Dr. MIDTHUN. As Dr. Bernier noted, wherever it is possible to reduce exposure to mercury, that is a goal that we would like to

achieve. Because there are many aspects of exposure that we don’t

have control over. For example, environmental food intake and

thus, it’s considered a precautionary measure that we can take. It’s

achievable, we can move from multi-dose vials that require a preservative to single dose vials. That’s what we have been doing, and

actually have made a substantial achievement toward reaching, as

I noted before, currently all vaccines being manufactured for pediatric use under the routine childhood immunization schedule, either contain no thimerosal or only trace amounts.

Mr. GILMAN. And that’s based on your recommendations?

Dr. MIDTHUN. That’s based on working collaboratively together

with the other public health service agencies and also the manufacturers, that it was agreed that this would be an achievable goal,

and it would be good to reduce the exposure to mercury whenever

possible.

Mr. GILMAN. So there is a consensus in the thinking of the medical world that it would be preferable to eliminate that possibility

in providing vaccines for children, is that correct?

Dr. MIDTHUN. It’s recognized that mercury in larger amounts is

a toxin. And thus, it is good to be able to reduce exposure. You can

never eliminate exposure. But it is good, where you can, to be able

to reduce it.

Mr. GILMAN. I will yield.

Mr. BURTON. Let me just ask, is mercury a cumulative thing in

the body?

Dr. MIDTHUN. I’m not a toxicologist.

Mr. BURTON. We had one yesterday. And the toxicologist, Mr.

Gilman, said that if you get a shot with mercury in it and then you

get another one and another one, there’s a cumulative effect. And

our children are getting 26 shots by the time they go to school.

I might add, did you get a flu shot?

Mr. GILMAN. Yes, I did.

Mr. BURTON. You got thimerosal. You got mercury in your body

from that shot, and Dr. Eisel, our admiral, I called him about it,

and he didn’t even know it was in there.

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Mr. GILMAN. That raises another good question. You have taken

some precautionary measures. What have you done with the public

so that they’re aware of these problems? What is your educational

process, what have you done in the educational process to the consuming public with regard to these concerns that you have in the

medical community?

Dr. MIDTHUN. Our labeling for products indicates what is in the

product. In the case where there is a preservative, it is so stated.

And——

Mr. GILMAN. I’m not asking just labeling. I’m asking you, have

you undertaken educational initiatives for the consuming public so

they’d be aware of these problems?

Dr. MIDTHUN. We believe that the vaccines are safe and effective,

including those vaccines that were licensed with thimerosal as a

preservative, sir.

Mr. BERNIER. Mr. Gilman, if I might add something, because

we’ve discussed this at CDC in anticipation that we might have

this question. I think one of the things that CDC has done, at least,

is we generally try to work with the provider community to try to

provide information about these matters. So in the last 22 months,

during the time when this episode has been ongoing, there have

been repeated publications, for example, in the morbidity and mortality weekly report at CDC, there have been joint statements between the Government agencies and the American Academy of Pediatrics and the American Academy of Family Physicians.

So we have worked to put information in the hands of the providers, so that they could address the concerns of the parents. Also,

we have had on our Web site information about these matters. We

have a hot line where parents can obtain information. So I wouldn’t

want to leave the impression that we haven’t been proactive, if you

will, about putting information out there. Because I think we have

been.

Mr. GILMAN. Well, you’re saying you’re putting it in the hands

of the providers. What about the consuming public? What are you

doing? You’re a government agency. What are you doing about educating the public about these dangers? What has been done by your

agency or any of the panelists who are here representing our government agencies? What’s been done to make the consuming public

aware of these mercury problems?

Mr. BERNIER. Well, like I said, at least speaking for CDC, traditionally we make, we work through the providers to address the

concerns of the parents to make sure——

Mr. GILMAN. You don’t go beyond the provider? If the provider

fails to make the information available, you’re satisfied?

Mr. BERNIER. Well, we have also the vaccine information statements that parents are given prior to vaccination, and that’s one

direct connection that we have with the parents at the time of vaccination.

Mr. GILMAN. Are these statements that your agency makes to the

parent?

Mr. BERNIER. Are they what, sir?

Mr. GILMAN. Are these statements that you make available to

the parent?

Mr. BERNIER. Yes.

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Mr. GILMAN. How is that distributed?

Mr. BERNIER. These are widely available, they’re required by law

to be made available to all the parents when children are immunized, before every immunization——

Mr. BURTON. If the gentleman would yield.

Mr. GILMAN. I’d be pleased to yield.

Mr. BURTON. And then we’ll get to Dr. Weldon.

Mr. Gilman, do you ever use a nasal spray?

Mr. GILMAN. No.

Mr. BURTON. Does your wife, or any of their friends?

Mr. GILMAN. My wife does.

Mr. BURTON. Do you know that most nasal sprays have thimerosal in them?

Mr. GILMAN. I didn’t know that.

Mr. BURTON. Yes. There’s mercury in a great many products that

we use as adults. And there’s a tremendous rise in the number of

cases of Alzheimer’s. And mercury has a debilitating impact on the

brain, as you saw, you probably didn’t see it, in that Calgary study.

So it’s not only the children that are being affected by this, in my

opinion. And I’m not a scientist. It’s all of us.

Because we’re getting mercury through the environment, but

we’re getting it in nasal sprays, and the health agencies, not too

long ago, took mercury out of all topical dressings, because they

said it would leach into the skin and cause problems. And yet, it’s

in nasal sprays, it’s in a lot of products we use as adults, and it’s

in our vaccinations, like the flu shot that you received.

Mr. GILMAN. Mr. Chairman, if I might reclaim my time. It would

seem to me there’s a responsibility by our agencies, whether it be

NIH, whether it be CDC, whatever agency is involved in regulating

our vaccines, that we make more information available to the public of the dangers of mercury, and make it available not only just

to potential users of the vaccine, but to the entire public.

So I’m urging those panelists who are here today to address that

problem, since it is a problem that can affect millions and millions

of our population.

Just one other question, Mr. Chairman. Parents are becoming

concerned about the vaccines that are already on the market that

have not been recalled, but many are unaware what’s being done

to make some recall or are unaware of your preventive actions or

your concerns, because you have directed the manufacturers to

take some steps to remove this product.

But what have you done with the product that’s still on the

shelves around the country?

Dr. MIDTHUN. It remains on the shelves, sir.

Mr. GILMAN. And could be used?

Dr. MIDTHUN. And could be used, that’s correct.

Mr. GILMAN. Shouldn’t you have some responsibility to remove

that, if you are concerned about its use?

Dr. MIDTHUN. Again, as I mentioned, there are certain conditions

that allow us to make a mandatory recall. And that is not one of

them. You have to have an imminent or substantial hazard to the

public health in order to make a recall.

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Mr. GILMAN. Are you concerned that if some of these products

are used, they could cause some problems in the health of young

people?

Dr. MIDTHUN. The evidence does not show that there is a causal

relationship between thimerosal as used in vaccines and autism.

Mr. GILMAN. And yet you recommended that it not be used in future manufacturing, is that correct?

Dr. MIDTHUN. That’s correct, because if we can decrease exposure

to mercury in ways that are available to——

Mr. GILMAN. If you’re concerned about the increase in exposure,

then why not take these products off the shelves and prevent their

distribution? If you really are sincerely concerned about the use of

these products, it would seem to me there’s an absence of responsibility here by your agency.

Dr. MIDTHUN. We have to follow the regulations as they are written, sir.

Mr. BERNIER. Mr. Gilman, could I add, I want to, I think, try to

correct an impression that I think is being generated here. That is

that the vaccine is not being recalled then nothing’s happening. I

think nothing could be further from the truth. Please allow me to

just take a minute to explain what has changed between, in the

last 22 months and today. And a lot has changed.

I think the impression is, well, if we don’t accomplish a recall

that somehow this problem is not being addressed. And I think

there are two or three things I’d like to point out.

Mr. GILMAN. Doctor, if I might interrupt, when we have faulty

tires on vehicles, we demand that they be recalled. If we have a

medication that’s on the shelf that could create some problem, it

would seem to me there’s enough evidence, even though it’s not

fully explored, that there’s enough evidence available that these

products should not be allowed to go out to the consuming public.

Mr. BERNIER. Mr. Gilman, we have no faulty vaccines on the

shelves.

Mr. GILMAN. You’ve already testified before us, at least Dr.

Midthun has testified that as a preventive measure, they’re recommending to the producer not to use this product. It would seem

to me that’s enough evidence to take the rest of the product off the

shelf.

Dr. MIDTHUN. We’ve not recommended that a product not be

used. We have worked with manufacturers to reduce the use of thimerosal as a preservative in vaccines.

Mr. GILMAN. And you’ve done that because you have a concern

about the future health of young people, isn’t that correct?

Dr. MIDTHUN. We have concerns about overall exposure to mercury from all sources in the environment. And this happens to be

a source that we can control by switching to single dose vials in

large part.

Mr. GILMAN. And these other products that are still on the shelf

could contribute to their poor state of health, is that right?

Dr. MIDTHUN. We do not believe that the products out there, we

believe that they are safe products, sir.

Mr. GILMAN. No further questions.

Mr. BURTON. Dr. Weldon.

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Dr. WELDON. Thank you, Mr. Chairman. I want to thank all the

witnesses for testifying. I certainly thank your efforts in trying to

answer and address the issues and concerns we have.

Dr. Rennert, you testified, I believe, that the total spending at

NIH will be $52 million on autism related research? Correct me if

I’m wrong, that is including a lot of autism related research, but

the actual figure on autism specific research is smaller than that,

is that correct?

Dr. RENNERT. I can’t tell you that for sure. I will tell you that

the list we submitted is correct. We will go back and review it and

provide you with the information.

Dr. WELDON. Yes, I would like you to personally provide that to

me, because I have had people come to me and say the net was cast

pretty wide to come up with a figure that high, and that the figure

for autism specific research is actually about a third or less of that.

And the reason I bring that up is, I had my staff pull a Congressional Research Study on AIDS. The figures that were provided to

me from CRS is that there’s 300,000 Americans currently suffering

with AIDS, and 115,000 living with HIV. Now, I realize some people estimate that those figures are quite a bit higher, and that

there’s a substantial cohort in the population who have exposure

to HIV, they’re carrying HIV and they don’t know it.

But if we use those figures and those figures have appeared in

the media, that’s about 415,000 people. The Federal expenditures

on research and treatment and the various care for those patients

with AIDS is $10.9 billion. Now, if we just look at the research

number, I have a figure of $3.1 billion in the year 2000. I could not

get the 2001 figure.

Now, I’m told we have about a similar number of kids with autism. That’s also very debatable, if you look at autism spectrum

disorder, you get a much larger number. When I do the math, it

comes out to, for research, about $7,000 per person with AIDS and

about $140 for each child with autism. Another way to look at that

figure is for every $7 we spend on AIDS related research, we’re

spending 14 cents on autism related research.

Do you, and I would ask any of the panelists to comment on this,

do you feel that, and I feel the ultimate responsibility for this rests

with the Congress, not with you, OK? So I’m not trying to make

you feel bad. I think we have a responsibility to make sure that

our money is spent, or the public’s money, the taxpayer money, is

spent appropriately. Do you think this is an appropriate level of

funding, a relatively appropriate level of funding?

Dr. RENNERT. You’ve evoked my bias as a pediatrician. I believe

our future is with our children. What I can tell you is that we will

spend more money on autism research. The numbers that I’ve presented, regardless for the moment of the magnitude, represent an

increase in funding at least in recent times, for this area. And I

certainly subscribe to the notion that this is an area that should

be an area of focus and emphasis for us.

Dr. WELDON. Well, does anybody else want to comment?

Dr. BOYLE. Sure, I’d be happy to.

Dr. WELDON. Are there adequate levels of funding for the types

of research studies that need to be done on this?

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Dr. BOYLE. We direct money at CDC as directed by Congress.

But I can tell you that in the last year, we have gotten a substantial increase in our funding for autism. And that’s really allowed

us to develop the State surveillance, State monitoring programs

that I referred to in my testimony. It’s allowing us to develop the

infrastructure to actually be doing a very large study of the epidemiology of autism.

So I feel that we have made substantial progress. But we have

a lot further to go.

Mr. GILMAN. Would the gentleman yield?

Dr. WELDON. I’d be happy to yield.

Mr. GILMAN. Have any of you made a request for additional moneys that have not been allocated for your autism research? Have

any of your agencies made a request for additional sums in the

budget that were not allocated to you? Or were you all satisfied

with the way the funds were being allocated?

Dr. WELDON. If I could ask it a different way, were all of your

requests granted to you by your superiors within the agencies you

work in?

Dr. MIDTHUN. May I just say that FDA, and the Office of vaccines, we don’t have the ability to ask for funding for studying autism per se. Our mission is to regulate vaccines.

Dr. WELDON. What about CDC and NIH?

Dr. RENNERT. The answer for NIH is no.

Dr. WELDON. We’ll make sure your future is secure in the year

ahead.

Dr. Boyle, I’ve got to ask you a question related to what you’re

doing. We had a physician testify yesterday about this increasing

incidence issue. And I think you came into my office once and we

talked about this, and the change in the diagnostic manual. He

made a very good point. Where are all the adults? If the prevalence

isn’t increasing, if the incidence isn’t increasing, then where are all

the adults? In all of these studies, you’re looking at prevalence and

incidence. Are you looking at prevalence in adults to try to make

a determination to answer that question, is the rate increasing?

Dr. BOYLE. Our studies have been directed at children. We primarily look at school age children, children age 3 to 10. That is a

very good question. And as may have come up yesterday, the prevalence, we call it prevalence only because we think most of it has

to do with sort of prenatal etiology, so that someone is either born

with the condition or with the specific genetic predisposition for the

condition. So we thought we’d refer to prevalence.

Dr. WELDON. Well, I would recommend you look at that issue,

looking at the disease prevalence throughout all age groups in the

population. Because I think that’s a very, very critical question, if

we are going to try to get——

Dr. BOYLE. I think Dr. Amaral testified yesterday about efforts

in California to address the issues of sort of changes in diagnosis,

as many researchers have suggested, as well as the greater awareness of the condition and the impact that has had on the increase

in the number of cases seen in California. Actually, I think that’s

going to be a very interesting study. It’s really going to be able to

shed some light on what’s happening.

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Mr. BURTON. Can we come back to you, Dr. Weldon? Mr. Waxman is here and he wants to ask a few questions, then we’ll come

right back to you.

Mr. WAXMAN. Thank you, Mr. Chairman.

Dr. Bernier, the CDC has explained that it is opposed to recalling thimerosal-containing vaccines because it’s concerned about

shortages. In fact, I understand there is a concern about a shortage

of DTaP vaccines. At the hearing yesterday, one of the witnesses

suggested that stocks of non-thimerosal vaccines are adequate and

that there was no need to keep thimerosal-containing vaccines on

the shelves.

Can you explain your concerns about shortages? For instance, if

the DTaP vaccine containing thimerosal were recalled, what possible effect would that have on our children?

Mr. BERNIER. Yes, Mr. Waxman, it is correct that at the present

time, for DTaP, there is a very tight supply situation. We have two

additional manufacturers that have left the market in the recent

past, and we are now left with only two manufacturers. And there

are back orders at the present time that cannot be filled because

the amount of available vaccine is not adequate to fill those back

orders.

So if in fact there was to be issued a strong preference for thimerosal free DTaP, or if there were to be a sudden recall of the

existing DTaP vaccine with thimerosal, this would produce spot

shortages which would create, we think, delays in children being

immunized, which could lead to disease very quickly.

In 1999 alone, there were 15 deaths from pertussis in the United

States. This year already we’ve had five deaths from pertussis. So

the need to continue the coverage with DTaP is very real. These

are not hypothetical or theoretical risks. We know that creating

shortages will produce coverage problems, will increase the risk of

children to these diseases.

Mr. WAXMAN. Last year, CDC testified that they were actively

monitoring possible adverse effects of thimerosal, the mercury-containing preservative that’s being phased out of vaccines. CDC found

no link between thimerosal and developmental delays. Have you

continued to monitor for any of these effects, and what has your

surveillance shown?

Mr. BERNIER. Well, we have continued at least in the look at the

autism question. In the original results from the vaccine safety

data link, there was no evidence of a link between thimerosal exposure and autism. In the last year, an additional number of cases

has accumulated. I believe somewhere in the vicinity of an additional 40 cases. When we add those cases to the ones that we

looked at before, we reached the same conclusion. It has not altered

the original conclusion, which was that there was no link between

exposure to thimerosal and autism.

Mr. WAXMAN. Thank you. Dr. Midthun, at the hearing yesterday

Dr. Haley testified about the toxicity of thimerosal-containing vaccines. He suggested that the thimerosal in vaccines was harmful to

children.

In the pre-licensure phase, is the vaccine tested for toxicity?

Dr. MIDTHUN. Yes, it is. The vaccines are usually evaluated in

a very large number of infants, if that’s the target population for

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whom they’re intended. They are tested with regard to the entire

formulation. And thus, if there were to be any acute toxicity, that

would be noted in the clinical trials that are done in support of the

license application.

Mr. WAXMAN. Does this mean that the entire vaccine, including

all of its component parts, is tested for toxicity?

Dr. MIDTHUN. That’s correct. The vaccine in entirety is tested.

Mr. WAXMAN. So if a vaccine were toxic, this should be revealed

in the prelicensure phase, is that correct?

Dr. MIDTHUN. Yes, that’s correct.

Mr. WAXMAN. What did the toxicity testing of vaccines with thimerosal reveal? Did this testing indicate that the thimerosal is

likely to pose health dangers for children?

Dr. MIDTHUN. The clinical studies did not suggest that, sir.

Mr. WAXMAN. So why did the FDA move quickly to remove thimerosal from vaccines?

Dr. MIDTHUN. Because we felt it was an achievable goal. It was

a way where we could reduce the overall exposure to mercury

among children, and it was something that was achievable, because

we could switch from multi-dose to single dose vials. In the United

States that was something that was feasible.

Mr. WAXMAN. Dr. Boyle, Dr. Wakefield testified at yesterday’s

hearing that we need active surveillance of vaccine adverse events.

Can you explain what CDC does to actively monitor potential problems associated with vaccines?

Mr. BERNIER. CDC is actively looking at vaccine safety events

through the VAERS system. We are monitoring events and when

events occur that create cause for concern, we have the resource

represented by the vaccine safety data link population, which is a

way of, provides us an easier means of testing hypotheses that may

arise from adverse events that are detected.

So we have this detection arm and then we have a testing arm

where we can test hypotheses. For example, this was one of the

ways in which it worked recently with rotavirus and

intussusception, where both arms of the vaccine safety mechanisms

were put into play in order to address that concern.

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

Mr. BURTON. Let me just followup on what Mr. Waxman said. I

know he has to leave and he’s probably not going to hear the response, but did you folks test the rotavirus vaccine before you put

it out on the market?

Dr. MIDTHUN. I’ve not been involved with the rotavirus vaccine

trials.

Mr. BURTON. It was tested by FDA, wasn’t it?

Dr. MIDTHUN. It was tested by FDA.

Mr. BURTON. And in 9 months it was recalled, wasn’t it?

Dr. MIDTHUN. Maybe I could ask Dr. Baylor. I wasn’t there at

the time.

Mr. BURTON. You don’t have to ask him. It was recalled, because

one child died, there were several serious problems, intestinal problems where there was surgery involved. And it was recalled.

Dr. MIDTHUN. I just spoke with Dr. Baylor. It wasn’t actually a

recall, either a mandatory or a voluntary recall. The company decided to withdraw it from the market, sir.

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Mr. BURTON. Well, because one child died, and a whole host of

them were injured. I mean, you know, you can cut it either way

you want to. The fact is, they took it off the market, and it had

been tested. So you folks are not infallible.

Now, the DPAT shot, are they still manufacturing that with thimerosal in it?

Mr. BERNIER. No, Mr. Chairman, they are not.

Mr. BURTON. They’re not. But you say that they’re not producing

enough of the single shot vaccines to take care of the needs of the

country at the present time?

Mr. BERNIER. At the present time, there is a shortage in the supply, correct. They are back ordered, and the new vaccine that they

are producing is not adequate to meet the demand at the present

time.

Mr. BURTON. How long will it take for that to be adequate?

Mr. BERNIER. I think the FDA could have a better idea of that.

My impression is that it’s, well, I mean, relatively short, and I’m

thinking of a few months. But I don’t have the information.

Mr. BURTON. So in a few months, they could have the supply up.

Now—— Mr. BERNIER. Could we just get FDA, because I don’t want that

to be on the record, if that’s true or not.

Mr. BURTON. How long will it take for them to get the single shot

vials, doses up to safe level?

Dr. MIDTHUN. I can’t give you the exact time line. But I do know

that there are two more lots potentially containing thimerosal that

the company intends to release. But after that, they will then be

releasing only the thimerosal reduced versions.

Mr. BURTON. How many shots are in a lot?

Dr. MIDTHUN. That’s proprietary information, sir.

Mr. BURTON. Do you want me to subpoena it?

Dr. MIDTHUN. I would be happy——

Mr. BURTON. You get it for me, or I’ll subpoena it. I want it.

Dr. MIDTHUN. I would be happy to respond to the chairman’s letter on that.

Mr. BURTON. Because what we’re talking about, there’s thousands and thousands of shots of DPAT that you’re going to put into

the system and kids are going to get those shots because of the

shortage.

Now, let me ask you, what’s the likelihood, let’s say it takes 6

months, let’s say it takes 6 months to get the single shots up to

snuff to where you’ve got a supply, let’s say it takes 6 months. How

many kids do you think are going to die in 6 months because they

don’t get that shot?

Mr. BERNIER. I can’t estimate, Mr. Chairman. I can tell you that

as I mentioned earlier in my testimony, this is not hypothetical. In

1999, there were 15 deaths associated with pertussis. And already,

there have been five deaths this year. So if we created a situation

where we abruptly said, you must use thimerosal free vaccine, that

would create shortages which would lead to delays which would

lead to what I’m calling days of lost protection.

Mr. BURTON. I understand. You’ve made your point. Let me just

say this. I want the names of the producers of the DPAT shot. And

I’m going to subpoena records from them to find out how much is

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in a lot, how they have two more lots that they have to use, they

have two more lots. I want to find out how long it would take for

them to produce the diphtheria, tetanus and the pertussis vaccines

individually. I’m going to find out how long it’s going to take.

Because I suspect that those lots have a lot of shots in them and

there’s a lot of money involved, a lot of money involved. And as a

result, they want to sell those before they go ahead and get their

lots of individual shots up to snuff. And I think it’s money, I really

believe that.

I think that there is mercury in those vaccines, and during the

time that you say two or three or four or five or six or seven children are going to possibly die, and we don’t want any child to die,

according to my figures, there are 16 children a day that’s going

to come down with autism. A day. That’s 17,520 children are going

to be at risk for autism in the next 3 years while studies are going

on, if mercury has something to do with it, as many, many people

believe.

Scientists, toxicologists, it’s not just me. We had a whole litany

of doctors from all over the world talking about this yesterday. And

what you’re saying is one thing. But what scientists and doctors

and studies have already shown is that mercury does have a debilitating impact on the brain. So you’re talking about children at risk.

In 3 years that it’s going to take to go through these studies,

17,520 children are likely to become autistic. If you folks are

wrong, how are you going to live with yourselves?

The gentlelady is recognized.

Ms. ROS-LEHTINEN. Thank you so much, Mr. Chairman. I regret

that I have not been able to be here for the entire hearing due to

an overbooked schedule. But I have the testimony and I look forward to reading it tonight. As I had said before, we have two good

friends of our family, Charles and Patience Flick, who have two

children who are afflicted with autism. I know what a terrible toll

autism can take on a family. Everything that the Flick family does

is related and surrounded by Bonnie and Willis and their care and

what will happen to them. And any steps the Flick’s take, Bonnie

and Willis are at the foremost of their thoughts.

Bonnie is a little more high functioning and was able to go to

Disney World with us. Willis is unfortunately so overstimulated by

the environment that he can barely leave his house. Everything is

too much sight and sound for him. So I look forward to seeing the

fruits of the pressure that Chairman Burton is bringing to bear on

this issue. We need to improve research dollars, and have more research going into the causes of autism, to help lead us to a cure.

Because I know how devastating that affliction is, not just on the

children who have it, but on their families.

We look forward to getting more evidence about the relationship

between vaccinations and the rise, dramatic rise in autism rates.

I know that many are not in agreement with that, but I congratulate Chairman Burton for his steadfast devotion and his bravery,

in spite of all of the attempts of the scientific and health community trying to make this seem like there’s no tie-in whatsoever. I

don’t think that we should leave any stone unturned. If mercury

is a factor, we should give serious consideration to revamping our

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vaccination program and looking at other possible factors involved

in the dramatic rates in autism across the country.

So I thank you, Chairman Burton, on behalf of the many Flick

families throughout the United States. Thank you, Dan.

Mr. BURTON. I thank the gentlelady.

Mrs. Morella, do you have any comments or questions?

Mrs. MORELLA. Actually, I commend you for the ongoing series

of hearings that you’ve had on autism. We all care about it. I’m

really here to listen, to learn and then to do what I can to lead and

I know you have medical experts before you, many of them who are

involved in laboratories in my district, NIH and of course FDA, and

I value CDC.

I’m also interested in the kind of funding that you do have. Really, we work very hard, just as an example, to double the funding

for NIH for that 5 year plan we had, so that by 2003 we would realize it. We are well on our way, this is our 4th year. I’m curious,

with regard to autism, and I must say, a lot of the leadership on

looking into autism obviously has come from the chairman, although I do wear sometimes my little jigsaw puzzle ribbon which

is autism, the puzzle pieces, right, which we are trying to put together.

I understand from your testimony, and I guess this would be Dr. Rennert, that $1 million is being set aside to fund innovative treatment proposals, and that you have 30 applications. How do you

work with that? Are you kind of a magician?

Dr. RENNERT. No, I think one works with it by trying to fund as

many grants as one can, and that the limit is the number of dollars.

Mrs. MORELLA. So how many do you think you can?

Dr. RENNERT. Well, I think again, the response I would make is

that the amount of funding we could use is equivalent to the number of meritorious proposals that there are. And it depends on

where you set the bar.

Mrs. MORELLA. Sounds like a political answer to me.

Dr. RENNERT. No, I can’t give you a precise number. But the

point is quite clearly, we could use more funding to fund more proposals and more research on autism.

Mrs. MORELLA. It just seems to me that of the 30 applications

and obviously probably not all would meet the qualifications, the

peer review, what it goes through, but certainly $1 million isn’t

going to fund more than a couple of them, probably.

Dr. RENNERT. Three to four is what that would fund.

Mrs. MORELLA. So it does say something about the need for us

to begin to look more into that in terms of the adequate funding.

Then I note also, looking at Dr. Boyle’s testimony, and I wasn’t

here to hear you synopsize it for the committee, but you mentioned

that CDC, NIH and 10 NIH funded centers and programs of excellence in autism are collaborating on a case control study of developmental regression. Each of these centers was awarded funds

through the NIH competitive process.

Can you give us like a time line on it, how that is going?

Dr. BOYLE. Actually, I may let my colleague at NIH address that.

Dr. RENNERT. Again, the program was initiated in 1997. And at

this point in time, as we mentioned in our testimony, there are apVerDate 11-MAY-2000 09:23 Feb 22, 2002 Jkt 000000 PO 00000 Frm 00395 Fmt 6601 Sfmt 6601 C:\DOCS\76856.TXT HGOVREF1 PsN: HGOVREF1
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proximately 2,300 patients with well defined autism that are a part

of the network and the study. The second part is with regard specifically to the question of the temporal association between vaccination and the onset of autism, as well as a study of the potential

effects of mercurials in vaccines as preservatives.

There are at the present time 1,600 cases that are being used for

the study. And the phase one part of the study will look at 250

cases of patients with early onset autism, 250 patients with regressive autism, and a corresponding number of controls for each

group. That work now is in the second phase where the analysis

will begin and the study of the biological specimens that were obtained.

A third part, because you mentioned it in regard to funding, I

forgot to point out though it was in my written testimony, that in

fact we will release in the coming year an RFA or request for applications for the competitive renewal and the commitment to renew

these centers for another 5 years. Clearly, our hope will be that

over time, that we could add more centers to this. But specifically,

the element of study that ought to be completed, as I was asked

by Chairman Burton in the next 2 years or so, is that these studies

linking or attempting to establish whether there’s an association or

what the association is between vaccination and thiomercurials will

be completed.

Mrs. MORELLA. Within 2 years, then, that’s what you’re saying,

2 to 3 years. Fine. Thank you, Mr. Chairman.

Mr. BURTON. Let me just say to the gentlelady, in 3 years is

what we thought was going to be the study, but if we waited 3

years to have a conclusion drawn, and we continue to use these

kinds of vaccines, we’re all for vaccinations, but not with some of

these things like mercury in them, there would be 17,520 new children that would probably be autistic. That is if mercury did have

something to do with it.

I think we’re about to wrap this up. We have a number of questions we’d like to submit to you for the record. I don’t want to keep

you here all day. Do we have any parents that have autistic children in the room? Would you raise your hands?

How many of you believe that your children were adversely affected by something in the vaccines? Would you raise your hands?

Is that everybody or almost everybody? About 80 percent; 8 out of

12, maybe 9 out of 12. That’s what we’re getting in e-mails by the

hundreds and thousands.

Now, maybe you folks are right, maybe mercury doesn’t have

anything to do with it. Maybe the thimerosal doesn’t. But they

think it does. And there’s a growing body of these people. And

they’re getting organized all across the country, and so is the Congress of the United States. So I really hope that you’ll take a hard

look at this. Because it isn’t going to go away. And as I said before,

it’s going to cost this country trillions of dollars.

In any event, do you have any other questions?

Mrs. MORELLA. No, I don’t, but of course I hope on the basis of

all of this that if you can expedite so that we can come to some

conclusions, because I can recognize the passion, but also the desire

for patience that’s so difficult for the chairman. And I would agree

393

with him, if it’s been going on since 1997, we should have some results. Thank you very much.

Mr. BURTON. Thank you, Congresswoman Morella.

We will submit these for the record.

There are documents that we’ll be requesting. If there’s a problem with you giving those because of confidentiality of any kind, if

you would let us know and we’ll be happy to legally send a subpoena to get that information, because we want to make sure we

have as much research material as possible.

We’d also like to know who are the manufacturers of the DPAT

shot.

Dr. MIDTHUN. I believe Ms. Clay has that.

Mr. BURTON. OK. We’ll be contacting them to get records on the

supply that they have and how long it will take to go to single shot

vials.

With that, thank you for being here. We stand adjourned.

[Whereupon, at 11:45 a.m., the committee was adjourned, to reconvene at the call of the Chair.]

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