[House Hearing, 107 Congress]
[From the U.S. Government Publishing Office]



 
           AUTISM--WHY THE INCREASED RATES? A ONE-YEAR 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


                     U.S. GOVERNMENT PRINTING OFFICE
76-856                       WASHINGTON : 2002
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                     COMMITTEE ON GOVERNMENT REFORM

                     DAN BURTON, Indiana, Chairman
BENJAMIN A. GILMAN, New York         HENRY A. WAXMAN, California
CONSTANCE A. MORELLA, Maryland       TOM LANTOS, California
CHRISTOPHER SHAYS, Connecticut       MAJOR R. OWENS, New York
ILEANA ROS-LEHTINEN, Florida         EDOLPHUS TOWNS, New York
JOHN M. McHUGH, New York             PAUL E. KANJORSKI, Pennsylvania
STEPHEN HORN, California             PATSY T. MINK, Hawaii
JOHN L. MICA, Florida                CAROLYN B. MALONEY, New York
THOMAS M. DAVIS, Virginia            ELEANOR HOLMES NORTON, Washington, 
MARK E. SOUDER, Indiana                  DC
JOE SCARBOROUGH, Florida             ELIJAH E. CUMMINGS, Maryland
STEVEN C. LaTOURETTE, Ohio           DENNIS J. KUCINICH, Ohio
BOB BARR, Georgia                    ROD R. BLAGOJEVICH, Illinois
DAN MILLER, Florida                  DANNY K. DAVIS, Illinois
DOUG OSE, California                 JOHN F. TIERNEY, Massachusetts
RON LEWIS, Kentucky                  JIM TURNER, Texas
JO ANN DAVIS, Virginia               THOMAS H. ALLEN, Maine
TODD RUSSELL PLATTS, Pennsylvania    JANICE D. SCHAKOWSKY, Illinois
DAVE WELDON, Florida                 WM. LACY CLAY, Missouri
CHRIS CANNON, Utah                   ------ ------
ADAM H. PUTNAM, Florida              ------ ------
C.L. ``BUTCH'' OTTER, Idaho                      ------
EDWARD L. SCHROCK, Virginia          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










                            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
    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








           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 December 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.
    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:]
    [GRAPHIC] [TIFF OMITTED] T6856.001
    
    [GRAPHIC] [TIFF OMITTED] T6856.002
    
    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.

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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    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 
co-sponsored 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 experts 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?
    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.
    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.
    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:]
    [GRAPHIC] [TIFF OMITTED] T6856.013
    
    [GRAPHIC] [TIFF OMITTED] T6856.014
    
    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.
    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.
    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 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:]
[GRAPHIC] [TIFF OMITTED] T6856.016

[GRAPHIC] [TIFF OMITTED] T6856.017

[GRAPHIC] [TIFF OMITTED] T6856.018

    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 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:]
    [GRAPHIC] [TIFF OMITTED] T6856.019
    
    [GRAPHIC] [TIFF OMITTED] T6856.020
    
    [GRAPHIC] [TIFF OMITTED] T6856.021
    
    [GRAPHIC] [TIFF OMITTED] T6856.022
    
    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.
    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 
over-focus 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 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 autism-MMR 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.
    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.
    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 
well-adjusted 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 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 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.
    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, physicians 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. 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.
    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.
    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 open-
mindedness 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 evaluation of alternative and 
complementary medicine. I am delighted with the progress made 
by the collaborative programs of excellence 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.
    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.
    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.
    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 8\1/2\ and 9\1/2\ 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 banging 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 looks into vaccine safety for fear of being 
blacklisted by the pharmaceutical 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-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.
    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 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.

 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 are going to fund additional personnel to care 
for the growing population 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 3\1/2\ 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, placebo-controlled 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.
    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.]
    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-the-block 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 investigation. 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.
    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 step-up 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.
    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.
    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.
    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 because 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 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 vaccination, childhood diseases, genetic factors, not to 
be exhaustive 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 estimated 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, 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 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 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 one-stop 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 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.
    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.
    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.
    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, 
2\1/2\ 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.
    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 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 absorbs 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 one-way 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 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----
    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.
    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.
    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?
    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.
    Mr. Waxman. I would like to read the conclusion of that 
abstract. ``Low levels of mercury can be detected in the blood 
of some full-term 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.
    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 
non-governmental 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 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 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.
    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.
    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 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.

   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 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 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----
    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.
    [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.
    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 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 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.
    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.
    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.
    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 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.
    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.
    [Whereupon, at 3:15 p.m., the committee was adjourned to 
reconvene at the call of the Chair.]
    [Additional information submitted for the hearing record 
follows:]
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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 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 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.
    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.
    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 environmental 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.
    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.
    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.
    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 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 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.
    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 withdraw 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.
    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.
    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.
    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.
    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?
    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.
    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 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.
    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 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 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 approximately 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 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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