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[House Hearing, 106 Congress]
[From the U.S. Government Publishing Office]

   AUTISM: PRESENT CHALLENGES, FUTURE NEEDS--WHY THE INCREASED RATES?

=======================================================================

                                HEARING

                               before the

                              COMMITTEE ON
                           GOVERNMENT REFORM

                        HOUSE OF REPRESENTATIVES

                       ONE HUNDRED SIXTH CONGRESS

                             SECOND SESSION

                               __________

                             APRIL 6, 2000

                               __________

                           Serial No. 106-180

                               __________

       Printed for the use of the Committee on Government Reform

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

                                 ______

                    U.S. GOVERNMENT PRINTING OFFICE
69-622 DTP                  WASHINGTON : 2001
_______________________________________________________________________
 For sale by the Superintendent of Documents, U.S. Government Printing 
                                 Office
Internet: bookstore.gpo.gov  Phone: (202) 512-1800  Fax: (202) 512-2250
               Mail: Stop SSOP, Washington, DC 20402-0001

                     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       ROBERT E. WISE, Jr., West Virginia
ILEANA ROS-LEHTINEN, Florida         MAJOR R. OWENS, New York
JOHN M. McHUGH, New York             EDOLPHUS TOWNS, New York
STEPHEN HORN, California             PAUL E. KANJORSKI, Pennsylvania
JOHN L. MICA, Florida                PATSY T. MINK, Hawaii
THOMAS M. DAVIS, Virginia            CAROLYN B. MALONEY, New York
DAVID M. McINTOSH, Indiana           ELEANOR HOLMES NORTON, Washington, 
MARK E. SOUDER, Indiana                  DC
JOE SCARBOROUGH, Florida             CHAKA FATTAH, Pennsylvania
STEVEN C. LaTOURETTE, Ohio           ELIJAH E. CUMMINGS, Maryland
MARSHALL ``MARK'' SANFORD, South     DENNIS J. KUCINICH, Ohio
    Carolina                         ROD R. BLAGOJEVICH, Illinois
BOB BARR, Georgia                    DANNY K. DAVIS, Illinois
DAN MILLER, Florida                  JOHN F. TIERNEY, Massachusetts
ASA HUTCHINSON, Arkansas             JIM TURNER, Texas
LEE TERRY, Nebraska                  THOMAS H. ALLEN, Maine
JUDY BIGGERT, Illinois               HAROLD E. FORD, Jr., Tennessee
GREG WALDEN, Oregon                  JANICE D. SCHAKOWSKY, Illinois
DOUG OSE, California                             ------
PAUL RYAN, Wisconsin                 BERNARD SANDERS, Vermont 
HELEN CHENOWETH-HAGE, Idaho              (Independent)
DAVID VITTER, Louisiana

                      Kevin Binger, Staff Director
                 Daniel R. Moll, Deputy Staff Director
           David A. Kass, Deputy Counsel and Parliamentarian
                    Lisa Smith Arafune, Chief Clerk
                 Phil Schiliro, Minority Staff Director

                            C O N T E N T S

                              ----------                              
                                                                   Page
Hearing held on April 6, 2000....................................     1
Statement of:
    Curtis, Kenneth, Catonsville, MD; James Smythe, Carmel, IN; 
      Shelley Reynolds, Baton Rouge, LA; Jeana Smith, Denham 
      Springs, LA; Scott Bono, Durham, NC; and Dr. Wayne M. 
      Dankner, San Diego, CA.....................................    49
    Rimland, Bernard, Ph.D., Autism Research Institute, San 
      Diego, CA; Dr. Michael J. Goldberg, Director, NIDS Medical 
      Advisory Board, Tarzana, CA; Dr. Mary N. Megson, Pediatric 
      and Adolescent Abilities Center, Richmond, VA; Dr. John E. 
      Upledger, the Upledger Institute, Clearwater, FL; Cathy L. 
      Pratt, Indiana Resource Center for Autism; Dr. Deborah G. 
      Hirtz, National Institutes of Health; Dr. Edwin H. Cook, 
      Jr., University of Chicago.................................   327
    Spitzer, Dr. Walter O., professor emeritus of epidemiology, 
      McGill University, and member, National Academy of Science 
      of the United States, Corpus Christi, TX...................   187
    Wakefield, Dr. Andrew, Royal Free and University College 
      Medical School, London, England; Dr. John O'Leary, Coombe 
      Women's Hospital, Dublin, Ireland; Vijendra K. Singh, Utah 
      State University; Coleen A. Boyle, Centers for Disease 
      Control and Prevention, U.S. Department of Health and Human 
      Services, accompanied by Dr. Ben Schwartz, Acting Director, 
      Epidemiology and Surveillance Division, CDC; Dr. Paul A. 
      Offit, University of Pennsylvania School of Medicine; and 
      Dr. Brent Taylor, Royal Free and University College Medical 
      School, London, England....................................   101
Letters, statements, et cetera, submitted for the record by:
    Bono, Scott, Durham, NC, prepared statement of...............    85
    Boyle, Coleen A., Centers for Disease Control and Prevention, 
      U.S. Department of Health and Human Services:
        Prevalence of Autism report..............................   198
        Prepared statement of....................................   148
    Cook, Dr. Edwin H., Jr., University of Chicago, prepared 
      statement of...............................................   463
    Curtis, Kenneth, Catonsville, MD, prepared statement of......    52
    Dankner, Dr. Wayne M., San Diego, CA, prepared statement of..    90
    Goldberg, Dr. Michael J., Director, NIDS Medical Advisory 
      Board, Tarzana, CA, prepared statement of..................   339
    Hirtz, Dr. Deborah G., National Institutes of Health, 
      prepared statement of......................................   450
    Megson, Dr. Mary N., Pediatric and Adolescent Abilities 
      Center, Richmond, VA, prepared statement of................   424
    O'Leary, Dr. John, Coombe Women's Hospital, Dublin, Ireland, 
      prepared statement of......................................   128
    Offit, Dr. Paul A., University of Pennsylvania School of 
      Medicine, prepared statement of............................   165
    Pratt, Cathy L., Indiana Resource Center for Autism, prepared 
      statement of...............................................   444
    Reynolds, Shelley, Baton Rouge, LA, prepared statement of....    70
    Rimland, Bernard, Ph.D., Autism Research Institute, San 
      Diego, CA, prepared statement of...........................   331
    Singh, Vijendra K., Utah State University, prepared statement 
      of.........................................................   142
    Smith, Jeana, Denham Springs, LA, prepared statement of......    77
    Smythe, James, Carmel, IN, prepared statement of.............    58
    Taylor, Dr. Brent, Royal Free and University College Medical 
      School, London, England, prepared statement of.............   173
    Upledger, Dr. John E., the Upledger Institute, Clearwater, 
      FL, prepared statement of..................................   435
    Wakefield, Dr. Andrew, Royal Free and University College 
      Medical School, London, England, prepared statement of.....   107
    Waxman, Hon. Henry A., a Representative in Congress from the 
      State of California:
        Documents from the Autism Autoimmunity Project...........   230
        Various prepared statements..............................     8

 
  AUTISM: PRESENT CHALLENGES, FUTURE NEEDS--WHY THE INCREASED RATES?

                              ----------                              

                        THURSDAY, APRIL 6, 2000

                          House of Representatives,
                            Committee on Government Reform,
                                                    Washington, DC.
    The committee met, pursuant to notice, at 10:37 a.m., in 
room 2154, Rayburn House Office Building, Hon. Dan Burton 
(chairman of the committee) presiding.
    Present: Representatives Burton, Morella, Ros-Lehtinen, 
McHugh, Horn, LaTourette, Hutchinson, Terry, Biggert, Ose, 
Chenoweth-Hage, Waxman, Norton, Kucinich, Tierney, and Turner.
    Staff present: Kevin Binger, staff director; Daniel R. 
Moll, deputy staff director; David A. Kass, deputy counsel and 
parliamentarian; Mark Corallo, director of communications; S. 
Elizabeth Clay, Nicole Petrosino, and Nat Weinecke, 
professional staff members; Robert Briggs, deputy chief clerk; 
Robin Butler, office manager; Michael Canty, legislative aide; 
Scott Fagan and John Sare staff assistants; Toni Lightle, 
legislative assistant; Leneale Scott, computer systems manager; 
Lisa Smith Arafune, chief clerk; Corinne Zaccagnini, systems 
administrator; Phil Schiliro, minority staff director; Sarah 
Despres, minority counsel; Ellen Rayner, minority chief clerk; 
Teresa Coufal, minority staff assistant; Jean Gosa and Earley 
Green, minority assistant clerks; and Andrew Su, minority 
research assistant.
    Mr. Burton. If I could have your attention, please. I know 
a lot of people have cameras, and I hate to throw a wet blanket 
on those of you who want to take some pictures, but unless you 
are a member of the media, I wish you would not take any 
pictures during the hearing. We will try to get the people you 
want to take pictures of together later; but please do not take 
a bunch of pictures during the meeting because it will probably 
disrupt what we are trying to accomplish.
    Good morning. A quorum being present, the Committee on 
Government Reform will come to order.
    I ask unanimous consent that all Members' and witnesses 
opening statements be included in the record. Without 
objection, so ordered.
    I also ask unanimous consent that all articles, exhibits, 
and extraneous or tabular material referred to be included in 
the record. Without objection, so ordered.
    We do have some Members who have opening statements, and we 
will allow those, and if they do not choose to give an opening 
statement and want to prepare one for the record, that will be 
fine as well.
    This morning we are here to talk about autism. As we 
learned in our August hearing, the rates of autism have 
escalated dramatically in the last few years. What used to be 
considered a rare disorder has become a near epidemic. We have 
received hundreds of letters from parents across the country. 
In fact, here are some notebooks, and each one of the pages 
represents a parent who has a problem with a child with autism.
    They have shared with us their pain and their challenges. 
My staff tells me that some of them cried when they read some 
of these letters--and I have a pretty hard-nosed staff.
    I do not have to read a letter to experience the kind of 
heartbreak that is in these letters. I see it in my own family. 
I am very proud of this picture. The one on the left is my 
grand-daughter, who almost died after receiving a hepatitis B 
shot. Within a short period of time, she quit breathing, and 
they had to rush her to the hospital.
    My grandson, Christian, whom you see there with his head on 
her shoulder, according to the doctors was going to be about 6-
foot-10--we anticipated having him support the family by being 
an NBA star--but unfortunately, after receiving nine shots in 1 
day, the MMR and the DTaP shot and the hepatitis B, within a 
very short period of time, he quit speaking, ran around banging 
his head against the wall, screaming, hollering, waving his 
hands, and became a totally different child. We found out that 
he was autistic.
    He was born healthy. He was beautiful and tall. He was 
outgoing and talkative. He enjoyed company and going places. 
Then, he had those shots, and our lives and his life changed.
    I do not want to read all the things that happened to 
Christian, because I am not sure I could get through it. But 
unfortunately, what happened to Christian is not a rare, 
isolated event. Shelley Reynolds will testify today. Her 
organization, Unlocking Autism, will be displaying thousands of 
pictures of autistic children at the ``Hear Their Silence'' 
autism rally this Saturday.
    Forty-seven percent of the parents who provided these 
pictures feel that their children's autism is linked to the 
immunizations--almost half. We frequently hear about the 
children with chronic ear infections and children who became 
autistic after spiking a fever with their vaccinations. Liz 
Birt was one of the hundreds of parents who contacted us. Her 
5-year-old son Matthew has been classified as autistic. He was 
developing normally. At age 15 months, following his MMR 
vaccine, he began to regress. Since the time of his 
vaccination, he has had chronic diarrhea. This is his picture--
a good-looking kid.
    This is very prevalent, this chronic diarrhea, in autistic 
children. Matthew also did not sleep on a regular basis for 
over 3 years. Liz took her son to numerous gastroenterologists 
in prominent medical facilities in the United States with no 
resolution. Finally, this past November, Liz took her son to 
London, to the Royal Free Hospital. A team of medical experts 
there examined Matthew. They felt that he had a bowel 
obstruction. To the family, this seemed impossible since he had 
constant diarrhea. An x-ray indicated that Matthew had a fecal 
mass in his colon the size of a cantaloupe. After the 
obstruction was cleared with laxatives, Matthew underwent an 
endoscopy and colonoscopy. The lesions in Matthew's bowel 
tested positive for the measles virus.
    Dr. Andrew Wakefield and Professor John O'Leary will be 
testifying today. Their research has uncovered a possible 
connection between inflammatory bowel disorder in children with 
autism who receive the MMR vaccine and have measles virus in 
their small intestines.
    Since coming home from England and being treated for 
chronic inflammatory bowel disorder, Matthew has finally begun 
to sleep through the night. I know that is a welcome relief for 
his family.
    Unfortunately, Matthew's story is not that unusual in 
children with autism. Our grandson has a similar problem. 
Unfortunately, it is important that I make two things very 
clear today. I, and I believe every Member of Congress, am not 
against vaccinations, and I do not think that every autistic 
child acquires autism after receiving childhood immunizations.
    I think slide 3 shows a lot of children who have had 
autism--is that correct--those are before-and-after pictures of 
the children.
    However, there is enough evidence emerging of some kind of 
connection for some children that we cannot close our eyes to 
it--we have to learn more.
    Dr. Mary Megson of Richmond, VA will testify about the 
correlation she has seen in children with autism and attention 
deficit disorder. She has seen a correlation between Vitamin A 
depletion and immune suppression after receiving the MMR 
vaccination.
    There are certainly children who are born with autism. They 
have what can be called ``classical autism.'' There is, 
however, a growing number of children who are growing normally 
and then acquire autism, or ``atypical autism.''
    There most probably is a genetic component to autism, but 
genetics is not the only issue. Many children seem to have 
severe food sensitivities, particularly to gluten and casein, 
ingredients in the most common foods, dairy and wheat. Many of 
these children show signs of autism shortly after receiving 
their immunizations. Some of these children, as we will hear 
from Jeana Smith, have metal toxicities, aluminum and mercury. 
What is the source of these toxic substances?
    Dr. Goldberg will testify that maybe what we are seeing is 
not autism at all, but a neuro-immunologic dysfunction.
    I am very concerned about the increased number of childhood 
vaccines. I am concerned about the ingredients that are put in 
these vaccines. I am concerned about the way they are given. We 
have learned that most of the vaccines our children are given 
contain mercury, aluminum and formaldehyde. Last year, the FDA 
added up the amount of mercury our babies are being given to 
learn that in the first 6 months of life, they receive more 
mercury than is considered safe. Think about that--in the first 
6 months of life, the FDA has said that children are receiving 
more mercury than is considered safe, and most of that is from 
vaccinations. Why is it that the FDA licenses vaccines that 
contain neurotoxins like mercury and aluminum?
    When asked about the increased rates of autism, many will 
immediately discount that there is even an increase--even 
though the latest statistics from the Department of Education 
show increased rate in every, single State. This slide shows 
you that every State has seen a dramatic increase.
    Others will say the increase is due to better diagnostic 
skills. Others will say it is because the diagnostic category 
was expanded. If we look at the slide showing California here, 
California has reported a 273 percent increase in children with 
autism since 1988. From this increase, 21 percent of all 
autistic children in California live in the 29th District, 
which is Henry Waxman's district, who is the ranking Democrat 
on our committee.
    Florida has reported a 571 percent increase in autism. 
Maryland has reported a 513 percent increase between 1993 and 
1998. You cannot attribute all of that to better diagnostic 
skills.
    In 1999, there are 2,462 children ages 3 to 21 in Indiana 
diagnosed with autism. That is one-fourth of 1 percent of all 
the school children in Indiana, or 1 out of every 400; 23 
percent of these children live in my district, the 6th District 
of Indiana.
    This increase is not just better counting. If we want to 
find a cure, we must first look to the cause. We must do this 
now, before our health and education systems are bankrupted, 
and before more of our Nation's children are locked inside 
themselves with this disease.
    Kenneth Curtis, part of ``Dave's Morning Show'' at Oldies 
100 FM here in Washington, will set the stage by talking about 
being the parent of an autistic child. He will be followed by 
James Smythe, of Carmel, IN. He will share how, through 
properly looking at autism as an illness and addressing that 
illness, his son is improving.
    Scott Bono, from North Carolina, lives close to one of the 
finest medical facilities in the world--Duke University. 
However, he has been unable to find medical experts to properly 
address his autistic son's needs. He is forced to drive 12 
hours every 4 weeks for his son's medical treatments.
    Dr. William Dankner, the father of a 13-year-old daughter 
with autism, and a scientist, will testify about the challenges 
of finding therapies and treatments that have adequate 
research. He will also talk about the battle of getting 
adequate education through the public school system. I think 
all of us who have autistic children or grandchildren know the 
problems that it involves.
    We hear repeatedly that parents are not informed at the 
time of diagnosis by their school system what educational 
options an autistic child is entitled to. It is only after 
hiring lawyers and going through the legal process that many 
children have access to appropriate educational opportunities. 
We are learning that the earlier autism is diagnosed and 
treatments are begun, the better it is for the child. Indiana 
is fortunate to have the First Steps Early Intervention System, 
a nationally recognized system that provides early intervention 
services for children up to 2 years of age.
    Families are forced to spend huge sums of money out-of-
pocket even when they have good insurance, because autism is 
often specifically excluded. We need to talk to State 
legislators around this country to tell them how important it 
is, with the explosion of autism, that these benefits be 
mandated by the States and be covered by insurance.
    California passed legislation recently to require insurance 
companies to cover autism. Parents spend $20,000 to $30,000 a 
year. What medical care is covered is often done after 
extensive struggles with insurance companies.
    We have a long hearing scheduled today with a broad 
spectrum of ideas presented. We will have a variety of medical 
approaches presented. We will hear about secretin, which gained 
a great deal of media attention in the past year and from which 
many parents have seen tremendous success.
    Dr. John Upledger, a former adviser to the Office of 
Alternative Medicine at the National Institutes of Health, will 
testify on the use of craniosacral therapy. He is the director 
of the Upledger Institute in Palm Beach Gardens, FL. For more 
than 25 years, Dr. Upledger has been treating autistic children 
and helping families through this approach. Craniosacral 
therapy is a gentle, powerful form of body work that directly 
influences the brain and spinal cord. It is used to treat pain, 
discomfort, or trauma to the head or face, including TMJ 
dysfunction and headaches. Craniosacral therapy can also 
relieve physical and emotional trauma.
    In addition to his work with autism, Dr. Upledger has 
achieved dramatic results in treating post-traumatic stress 
disorder in Vietnam veterans.
    In addition to medical treatments for the physical symptoms 
of autism, there are numerous therapies that are needed to help 
autistic children. Special educational approaches are needed 
that can include intensive behavior modification, known as ABA, 
Lovass, music therapy, speech therapy, auditory integration and 
sensory integration, as well as play therapy.
    We will hear from both the Centers for Disease Control and 
Prevention and the National Institutes of Health about ongoing 
research and future needs. Of particular interest is the Brick 
Township study which has been evaluating a cluster of autism in 
New Jersey.
    This hearing will raise more questions than we can answer 
today. We owe it to our children and to our grandchildren to 
ensure that we are being diligent in looking for the causes of 
autism. We have to do everything humanly possible to determine 
if there is something that can be done to unlock our children 
from the prison that they are in as a result of autism. I think 
that as a top priority, we have to do much more research on the 
potential connection between vaccines and autism. We cannot 
stick our heads in the sand and ignore this possibility.
    If we do not take action now, 10 years from now, it may be 
too late, not only for this generation of children, but for our 
taxpayer-funded health and education systems, which could 
collapse from trying to care for all of these children.
    The hearing record will remain open for 2 weeks.
    I now yield to my colleague from California, Mr. Waxman, 
for his opening statement.
    Mr. Waxman. Thank you very much, Mr. Chairman.
    I am glad we are having this hearing today on autism. We 
still have many questions about autism--what causes it; what 
are the safest and most effective treatments; is there a way to 
prevent it; how many people in the country suffer from autism?
    We do know some things about autism. We know there is a 
genetic component to autism. There have been some dramatic 
discoveries recently in the genetics of autism like the 
discovery of the Fragile X gene and the gene that causes Rett 
syndrome. We know that autism most likely develops very early 
during fetal development. We also know that parents are not to 
blame for autism. We have come a long way from the time when 
fathers and mothers were led to believe that they had done 
something to cause their children's autism, leaving them with 
needless and destructive guilt.
    But I also understand that this hearing was called to 
consider a theory that certain vaccines cause autism. From my 
discussions with medical experts, scientists, and the autism 
community, it is clear that this is only a theory. As the 
American Medical Association concluded recently, ``Scientific 
data does not support a causal association between vaccination 
and autism.''
    I believe that we need to increase our efforts to 
understand the causes of autism. In this search, no possible 
cause, including vaccines, should be off the table. That is why 
I am a cosponsor of H.R. 3301, which would provide additional 
funding at NIH for research into what causes autism, how many 
people suffer from autism, and how best to treat those who have 
autism.
    But in this process, we must not get ahead of the science 
or raise false alarms. At every hearing in this Congress that 
this committee has held touching on childhood immunizations, I 
have made a point of emphasizing the tremendous public health 
value of immunization. More Americans have been saved by 
vaccines than by any other medical intervention. Across the 
globe, 2.5 million children die every year from childhood 
diseases; another 750,000 are crippled by these diseases. But 
American children are shielded from this death and misery by 
their vaccinations.
    During my 25-year career in Congress, my focus has been on 
improving health care, especially for children. When I was 
chairman of the Health and Environment Subcommittee of the 
Commerce Committee from 1979 to 1994, we worked constantly to 
expand NIH research into childhood diseases. I have continued 
to fight for more research, better treatments, and coverage 
while I have been in the minority. During countless hearings 
and many legislative battles, I have heard over and over again 
about the pain of parents whose children suffer from 
debilitating diseases.
    So I sympathize with the parents who are here today. I know 
how painful and how hard it must be for you as parents to have 
children who appear to be developing normally and then, all of 
a sudden, seemingly out of nowhere, stop communicating and stop 
developing.
    We need to do everything we can to give these parents here 
and other parents around the country answers. There is still 
much to learn. In medicine the best answers come from research 
that can withstand the rigors of the scientific method. These 
standards have been developed in order to find the truth. If 
research has been conducted with control groups, and the 
results have been independently validated, then that gives 
parents meaningful information about what causes a disease or a 
condition and what the best treatments are.
    Parents and doctors need the best possible information so 
that they can make the best possible decisions regarding their 
children's health.
    There are lots of experts and groups that are knowledgeable 
about this issue but who were not invited to testify today. 
These groups include Dr. Louis Sullivan, former Secretary of 
Health and Human Services, and current president of the 
Morehouse School of Medicine; Dr. Isabelle Rapin, from the 
Albert Einstein College of Medicine; the American Public Health 
Association; the American Medical Association, and the National 
Network for Immunization Information. At this time I would ask 
unanimous consent that all of their statements be entered into 
the record.
    Mr. Burton. Without objection, so ordered.
    [The information referred to follows:]
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    Mr. Waxman. I thank all the witnesses who are here today 
for appearing. I know how difficult it is for some of them to 
be here, how hard it is to share their pain, and how much they 
want their testimony to be a way for us to understand that we 
in the Congress must do everything we can, consider all 
theories, get to the truth about autism, what causes it, what 
we can do to treat it, and how we can prevent it. I see that as 
our job today, and I look forward to the testimony and learning 
from the witnesses who are here to share their perspectives 
with us.
    Thank you, Mr. Chairman.
    Mr. Burton. Thank you, Mr. Waxman.
    Mrs. Morella.
    Mrs. Morella. Thank you, Mr. Chairman. I appreciate your 
effort to hold this important hearing on autism, and I look 
forward to hearing the testimony of the witnesses.
    I come to this hearing today with an open mind, ready to 
listen carefully to the testimony of the witnesses. Autism and 
its associated behaviors have been estimated to occur in as 
many as 1 in 500 individuals. Over 500,000 people in the United 
States today have some form of autism. The estimated prevalence 
rate of autism now places it as the third most common 
developmental disability--more commonly occurring than Down 
Syndrome.
    Mr. Chairman, in your opening statements, you mentioned 
that there was a 513 percent increase in my State of Maryland 
between 1993 and 1998, and I notice that the first witness on 
our first panel, Mr. Curtis, is from Maryland.
    Unfortunately, there is almost no existing data on causes 
or links to causes of autism in children. I am very concerned 
with these striking statistics. I am most concerned with the 
lack of information and the confusion surrounding the issue of 
vaccines and their relationship to autism.
    I hope that today we can come closer to discerning what the 
appropriate steps are for this committee and for Government to 
take. I hope to learn from testimony that will make this 
committee better understand where we need to focus research 
dollars, be it through vaccines, genetic or environmental 
factors, and the question of why is autism four times more 
prevalent in boys than in girls. I hope to get some sense of 
what further studies are needed so that we can accelerate 
research on autism.
    There is no question in my mind that this is an issue of 
high priority and that more studies are needed. That is why I 
wrote to our Representative John Porter, who chairs the House 
Subcommittee on Appropriations for Labor and Health and Human 
Services, requesting an increase in funding for autism 
epidemiology research at the National Center for Environmental 
Health within the Centers for Disease Control and Prevention, 
an appropriation of $1.5 million for the CDC to expand its 
epidemiology activities in autism from two isolated studies to 
a more national scope.
    An increase in funding for autism epidemiology research in 
2001 will enable CDC to expand monitoring efforts to other 
parts of the country. This will allow them to better understand 
the prevalence of autism spectrum disorders--information which 
is necessary to eventually discover prevention, treatment, and 
a cure for autism.
    I think that the choice of this ribbon with its puzzle 
pieces as the symbol of autism, with the heart in the center, 
is most appropriate.
    I yield back and look forward to hearing from the 
witnesses.
    Mr. Burton. Thank you, Mrs. Morella.
    Mrs. Chenoweth-Hage.
    Mrs. Chenoweth-Hage. Thank you, Mr. Chairman.
    I can hardly begin to thank you enough for holding this 
hearing. It is astounding to see all of these people who have 
come from all over the Nation, and I understand, Mr. Chairman, 
that you have arranged for two overflow rooms, and I noticed 
that the hall was packed when I came in.
    I rarely ask to make an opening statement, but I am unable 
to overstate the importance of this particular issue, and I 
look forward to hearing the testimony from the witnesses today 
and learning more.
    Mr. Chairman, oftentimes, I focus on the larger issues at 
hand when I address the committee, but I too am the grandparent 
of an incredibly handsome autistic child--an incredible boy. I 
cannot overemphasize how much autism affects education and 
family cohesiveness in the most loving of families. All of 
these are irretrievably affected when autism is discovered in 
one's own family.
    Mr. Chairman, when Timmy was born, neither my daughter nor 
my son-in-law knew that he was autistic. They did not have a 
clue. He was the youngest of four children, so his parents 
thought they knew what to expect in raising a baby. It was only 
later that they realized that there was something very 
different about Timmy. When he was diagnosed with autism, we 
were all worried and saddened. How would our family deal with 
this? How could he be educated, and how could we best provide 
for his future? How could, how could how could? And it went on.
    We had hundreds if not thousands of questions. We were 
shocked and frightened and worried and relieved to know what it 
was, all at the same time. At the same time, none of us knew 
what the future held, and the questions kept coming.
    That is why I am so very grateful to you, Mr. Chairman, for 
your courage and willingness to deal in areas that the Congress 
usually is not willing to open its mind to.
    Timmy is now 8 and is a beautiful young boy whom we are all 
immensely proud of. However, I cannot understate the challenges 
that our family still faces. Parents are desperate to find an 
answer to their questions. They want so much for their children 
to have integrative and communicative lives. Oftentimes, they 
feel at a loss, almost desperate, in trying to find answers to 
their questions. Many of my family's questions still remain. 
Day after day, we still search for answers. It is an overriding 
concern with all of us.
    While our questions are not all easily answered, even the 
beginning of the questions, we do somehow manage to look toward 
a brighter future for Timmy than we ever thought possible after 
his initial diagnosis. He was a gifted child in a number of 
areas, particularly music. But we still want to learn how to 
unlock the full potential of his future.
    All too often, people will write off such potential, but it 
is there. We are all sure of it. You can literally look in his 
eyes and see it.
    Mr. Chairman, autism is a very strange disorder. When Timmy 
was diagnosed, we were told that medical science did not know 
the cause of it. We were told that Timmy had about a 4 percent 
chance of leading a normal life, depending on his IQ. They 
thought autism was probably genetic, but they really just were 
not sure.
    After much research, we discovered his current schooling 
program, which is based on extensive research done by Dr. Iver 
Lovass of California. At first, quite simply, we encountered a 
vacuum of knowledge when it came to autism, and that shocked 
me. However, what shocked me even more was learning that the 
rate of autism has increased over the past several years, and 
the statistics which you show today, Mr. Chairman, are 
incredibly shocking.
    I continue to be surprised when I discover that some 
studies have found preliminary evidence of a link between 
autism and vaccines, and evidence linking dietary health to 
autism. Vaccines and dietary health are issues that I have been 
very interested in for some time now, and I look forward to 
hearing from the witnesses who will address these links.
    Mr. Chairman, we understand from the research that was the 
foundation of Dr. Lovass' program, ``Ready, Set, Go,'' that the 
chances of Timmy leading a normal life rose from 4 percent to 
nearly 20 percent, and this is based on the intensive 
behavioral intervention program developed after decades of 
research by Dr. Lovass. You can imagine the impact this program 
has had on countless children and their families.
    Research in this area changes lives, as I am sure research 
regarding vaccinations and dietary health has changed the lives 
of numerous others. The astounding results of research into 
this terrible disorder have changed the lives of many families, 
and as a result of this research, I am aware of families that 
have literally upended their lives to move across the country 
in search of programs like that of Dr. Lovass.
    Mr. Chairman, there are some remarkable programs that have 
developed over the years with regard to autism, in particular 
some amazing advances in educating autistic children. But we 
still need more answers.
    Mr. Chairman, again, let me thank you and the committee and 
the hard-working staff of the committee for holding this 
critically important hearing. For better or for worse, we must 
deal with this subject. This committee is taking a very 
important first step.
    Thank you, Mr. Chairman.
    Mr. Burton. Thank you very much, Mrs. Chenoweth-Hage.
    Mr. Kucinich.
    Mr. Kucinich. Thank you very much, Mr. Chairman.
    I have to first inform you that I have a markup and votes 
in another committee, so I will not be able to stay. But I did 
want to come here specifically to support the cause of this 
hearing and your efforts in this regard.
    While I agree with Mr. Waxman when he says the history of 
vaccinations has shown a lot of benefits, it is important for 
science to take note of the increased reporting with respect to 
rates of autism in recent years. If we have a higher incidence 
of autism, this is an appropriate subject for a congressional 
inquiry, and I think it is also appropriate for us to ask 
questions not only of the witnesses here today but of the 
industry producing these vaccines. I am particularly interested 
in what are their production protocols for the vaccines which 
our children receive; how are the vaccines being made; what is 
in the vaccines; are there any differences in how the vaccines 
were made years ago and how they are made today; are there any 
different products in there?
    These are questions which could lend themselves to an 
understanding of why there is an increased rate today, and it 
seems to be different than what it was years ago.
    So I think that when you see the heartfelt concern which is 
expressed here, the witnesses who are appearing and are 
scheduled to appear, and when you see that there are scientists 
who are willing to address the question of a causal link 
between autism and a vaccine, and when you have a scientist who 
is ready to say maybe there is not a causal link--the fact that 
this debate has begun here suggests an important moment in this 
Congress and in this country on the issue of autism. We need to 
find out if there is a link, and if there is a link, we need to 
go right back to the way the vaccine is made and what it is 
made of--because the problem may not be in our children; the 
problem may be in what our children are being given.
    So I thank you very much for your diligence, Mr. Chairman, 
and for your commitment and for your quality of heart on issues 
of public health importance.
    Mr. Burton. Thank you, Mr. Kucinich, and I want to thank 
you for all the help you have given us on a whole host of 
issues relating to the health of the people of this country.
    Mr. Kucinich. I want to say I would not be on this 
committee if it were not for Mr. Waxman inviting me to be on 
this committee, and I am on it because of my deep respect for 
Mr. Waxman, whom I revere as not just our leader, but for me, 
he has been a personal hero. But I think I am on a committee 
with two of the best people in the House, so I am pretty 
fortunate.
    Thanks.
    Mr. Burton. I hope everybody heard that. That was from the 
other side of the aisle. [Laughter.]
    Mr. Burton. Mr. Ose has said he does not have an opening 
statement.
    Mr. Hutchinson, do you have an opening statement?
    Mr. Hutchinson. No, Mr. Chairman.
    Mr. Burton. OK.
    We will now proceed with our witnesses. As a practice, 
especially since we are talking about something as important as 
the various problems that have been occurring with you folks 
with autistic children, I would like to ask everybody to rise.
    On our first panel, we have Mr. Kenneth Curtis, Mr. James 
Smythe, Ms. Shelley Reynolds, Ms. Jeana Smith, Mr. Scott Bono, 
and Dr. Wayne Dankner.
    Would all of you raise your right hands, please?
    [Witnesses sworn.]
    Mr. Burton. Please be seated.
    Mr. Curtis, would you like to start? What I would like to 
ask, because we have 19 witnesses, and this is a very big 
hearing today, is if you could try to confine your remarks to 5 
minutes. Some of the doctors who have technical expertise that 
they want to express will be allowed a little latitude, but if 
you could stick close to 5 minutes, we would really appreciate 
it.
    Mr. Curtis, would you like to start?

 STATEMENTS OF KENNETH CURTIS, CATONSVILLE, MD; JAMES SMYTHE, 
  CARMEL, IN; SHELLEY REYNOLDS, BATON ROUGE, LA; JEANA SMITH, 
 DENHAM SPRINGS, LA; SCOTT BONO, DURHAM, NC; AND DR. WAYNE M. 
                     DANKNER, SAN DIEGO, CA

    Mr. Curtis. Certainly. Mr. Chairman, all of you, first of 
all, thank you for this opportunity to speak on behalf of my 
son----
    Mr. Burton. Would you pull the mic a little closer? The 
mics do not pick up as well as we hope.
    Mr. Curtis. Sure. Leave it to the radio guy to mess up the 
microphone.
    Thank you again for this opportunity to speak on behalf of 
my son, my family, and children with autism nationwide; but 
mostly I am speaking on behalf of my son, because this is 
really his story.
    Autism does not announce itself in the delivery room. When 
our son Morgan Scott was born, he looked like a Sharpei dog--he 
was wrinkled from head to toe. Things were sort of storybook 
for us at that time. We had a girl and a boy, a mom and a dad, 
and life was kind of like a picnic. But the clouds were rolling 
in, as it were.
    Slowly, little drops of doubt began to fall. We wondered 
about the way he liked to watch Disney videos over and over, or 
how he would spin around and make strange noises and look at 
things out of the corner of his eye; the way he liked to line 
up his toys. Drop after drop--we wondered, and we waited to see 
what would happen.
    He did not talk, and most of the time, he did not even seem 
to hear us. So we worried some more, and we wondered, until all 
of these little drops were like a downpour--and of course, we 
had to take cover.
    Our doctor suggested a hearing test, but his ears were 
fine. He just would not talk. We tried speech therapy, but he 
still would not talk. Even with all of these odd behaviors, my 
son was a happy enough kid. He was loving, affectionate, he was 
ticklish, stubborn--just like any kid--but he would not talk.
    Finally, when Morgan was a little more than 2 years old, we 
had a word for it, and the word was more terrifying and 
confusing than any of the things we were dealing with at the 
time. Of course, the word was autism.
    But what did that mean? Of course, we thought of ``Rain 
Man,'' but we also thought of all the horrible stories you hear 
about kids who repeatedly bang their heads against the wall, or 
bite, scratch, and sit in a corner, rocking and hugging 
themselves. Is it possible that this could be our little boy? 
It did not seem real--but obviously, it was.
    Morgan was diagnosed as ``moderately autistic,'' a term I 
have always thought to be a bit like being ``moderately 
pregnant.'' So we began to immerse ourselves in information. We 
were determined to learn everything possible about autism--and 
when I say ``we,'' I really mean my wife Kimberly. You have 
never seen a woman on a mission until you have seen a mother 
determined to save her child. There is no match for a mother's 
love. She read, she researched, she investigated, while I tried 
to come to terms with the idea that I might never be able to 
shoot hoops with my son.
    Before long, we had a plan. We opted for the one-to-one 
intensive ABA therapy program developed by Dr. Lovass at UCLA. 
We spent thousands of dollars, wrangled with the school system, 
hired lawyers, lived in my grandmother's house to save on rent, 
and we began teaching our son in-home.
    For 5 years, Morgan had between 30 and 40 hours a week of 
one-on-one therapy. At age 4, my son had more college friends 
than most fraternity brothers. He learned to read a little, to 
spell a little, to use the toilet--and most importantly, he 
learned how to listen to people, and he even began to talk a 
little bit.
    I am a radio guy--I talk for a living--and the irony of 
having a son who does not know how to communicate with words is 
not lost on me. I know there are things that my son wants to 
say to me, and as he gets older, I can look into his eyes and 
see the frustration and the confusion. There is a little boy 
inside of him somewhere, and it is as if he is lost.
    This is really what it is like. It is like being in the 
mall with your child, and you look down and discover he is not 
there anymore--that sickening feeling you get in the pit of 
your stomach. Except that every once in a while, I catch a 
glimpse of the real boy--the way his eyes light up when you 
bring the Christmas tree home; the way he smiles when he jumps 
into the pool, or the way he sits perfectly still, enraptured, 
when he got to see the symphony. He loves music, he loves 
animals, he loves trains, books, swings, ice cream, and even 
his family, of course.
    But he cannot tell me his favorite color, or how his day at 
school was, or what hurts when he falls off the swing set. He 
still has not figured out how to express or reveal himself. And 
he does not seem to understand why this is so important to us.
    I want to know why my son is locked inside himself. Is 
there a genetic disposition? Is it environmental? Is it 
something in the water? Do pesticides cause it--preservatives; 
antibiotics; immunizations; Nutrasweet; the time he fell and 
hit his head? It sounds crazy, but these are the things we have 
all heard and thought about, and the truth is we have no idea 
why our son is autistic, and we have to accept that.
    But we love our son so much that we can never give up hope 
that he will 1 day carry on a conversation with us or even just 
say, ``Hi, Dad,'' when I come home from work.
    Morgan is a truly beautiful person in his own right just as 
he is right now. I have never met anyone, and I doubt I ever 
will, who lives more in the moment than my son. He is 
affectionate, imaginative, and even humorous sometimes. And I 
have learned more from him than I have from any other single 
person in my entire life. He is autistic, and that is just the 
way he is.
    But not everybody is as lucky as we are. Morgan is not 
aggressive or self-injurious like a lot of individuals with 
autism. He is 8 years old. I have had a lot of time to come to 
terms with this. Even so, the frustration of dealing with 
autism is nearly eclipsed by the frustration and the lack of 
concrete information about this disorder.
    Autism used to be considered rare, the kind of thing you 
see in movies or read about in books, but it never actually 
happened to anyone you knew. In January of this year, the 
Autism Society of America estimated that autism had increased 
from 15 out of every 10,000 individuals to 1 in 500. And the 
repercussions of this increase are so far-reaching.
    These children will need specialized education and 
appropriate care for the rest of their lives. Are we honestly 
ready for this? Are our schools equipped to handle this 
increase? This overwhelming surge in this disorder is not just 
going to affect individual families. This is going to impact 
our community and the entire world in which we live.
    My son is a beautifully colored thread in the fabric of my 
family. But even so, 1 in every 500 families should not have to 
live with this disorder. And what if these numbers keep 
increasing?
    So here I am today, wearing the only suit that I own, 
discussing my son before the legislative arm of the ruling body 
of the greatest Nation in the world. Believe me, testifying 
here today is one of the most important things I have ever 
done, and with all due respect to the tremendous body of work 
before each of you, I would like to think that it is a very 
important day for you as well.
    Thank you.
    Mr. Burton. Thank you very much, Mr. Curtis.
    Mr. Smythe.
    [The prepared statement of Mr. Curtis follows:]
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    Mr. Smythe. Thank you very much, Congressman Burton, 
Congressman Waxman, and other Members of Congress, for this 
opportunity to speak here for my son and for the tens of 
thousands of autistic children around this country and the 
millions of people who are affected by this, literally--
parents, brothers and sisters, aunts and uncles, grandparents, 
and so on.
    I will keep my remarks to 5 minutes, but I would like to 
make three points here, and I would like you to write these 
down.
    The first is that living with these children can be hell. 
They can destroy your entire home. You cannot keep anything 
nice around. They will ruin your rugs. They will jump off the 
furniture. They will move the furniture around the room, push 
it over, break things, clear counters with one sweep of the 
arm. And they do all of these things with no malice whatsoever.
    One cannot take them to friends' homes. One cannot stay 
overnight at friends' homes. When one is at a friend's or a 
relative's home, they will be worse there because it is a 
strange environment.
    The second point is that no one to my knowledge is 
consistently measuring acquired autism. And Congressman Waxman, 
you mentioned that there is no causal connection between autism 
and vaccines.
    Mr. Waxman. I did not say that.
    Mr. Smythe. That there is no measurable causal connection.
    Mr. Waxman. I said there is a theory, and that theory is 
still controversial.
    Mr. Smythe. Is unproven. And I would suggest to you that we 
are now defining autism behaviorally; that certain activity, 
certain behaviors on the part of these children cause them to 
be classified as autistic, and then, most of the medical 
community gives up. And there is a difference between classical 
autism, a child who is born autistic, that one knows is 
autistic, and most doctors have been trained about autism 
because that is the way they were born, and they show up that 
way; and this late-onset autism that we are seeing, this 
acquired autism, if you will. There is a tremendous difference, 
and there may be many different medical causes. But because, in 
our language, we are not making that distinction, we are not 
able to follow medical cures or even medical causation. So that 
is an important distinction which I think needs to be made for 
all of us and by the NIH.
    If you look at the insurance companies, if a child is 
labeled autistic, they will not cover it. It does not matter 
what the cause of that behavior is. If you look at the 
educational models, if you speak to the professionals in 
education, they do not have a distinction to my knowledge in 
the way that children who are acquired autistic are trained, 
compared with children who are classically autistic, how they 
are educated. The end result is that our educational models are 
not recognizing that some of these children may in fact just 
simply be sick; they may just simply be diseased. As a result, 
we are letting them down, and they are going through the 
educational system basically being warehoused, without any 
treatment, either medically or educationally.
    From a financial standpoint, the stresses are huge. When 
one has an autistic child, suddenly, a whole new world of 
potential trauma has opened up, and there is very little known 
on this subject with regard to treatment.
    We have followed a number of different treatment programs--
auditory integration therapy, vision therapy, speech therapy, 
occupational therapy, and sensory integration therapy. We have 
participated in swimming and horseback riding, had CAT-scans, 
allergy testing, stool analysis and urine analysis, and all 
kinds of blood analysis. What we have noticed is that there is 
often kind of an uncaring attitude by the providers of many of 
these services, that ``Maybe we will find out what is going 
on.'' But their house is not being destroyed. They do not have 
the motivation or the drive, it seems, to research this 
process. But it is very important to research.
    Our school system is so overwhelmed that a recent 
Indianapolis Star article said that the State of Indiana has 
now changed the rules, so that a special education teacher can 
include anyone who has a college degree. What kind of special 
education is that? There is such a need out there, and the 
burdens are only going to become much greater.
    The waiting list for Indiana's Medicaid waiver in order for 
a parent to get some financial assistance here is 3 years, and 
as I understand, it is growing--it has to grow--with the 
increase in the numbers of these children.
    The ignorance in the insurance industry is phenomenal. I 
noticed that Secretary Shalala and the First Lady spoke about 
the use of ritalin in children, and I have heard that 10 to 20 
percent of children are now on ritalin. Has it occurred to 
anyone that there may very well be and almost certainly is a 
causal connection that is related between ADD and this increase 
in autism; that they may be all part of one spectrum? I suggest 
that this needs to be looked at. But we have to make 
distinctions in language in order to do that.
    Mr. Burton. Mr. Smythe, if you could summarize, please, we 
would appreciate it. I know that you have a lot to cover, and 
we do appreciate your testimony.
    Mr. Smythe. Thank you, Congressman.
    The bottom line is that there are ways to measure how at 
least some of what is now showing up as autistic behavior, 
seems to be immune-related is affecting the brain differently 
from most of us, how it can be treated and then cured, and how 
the treatment itself can be seen to produce results in the 
return of blood flow to the brain.
    I sincerely request that the members of this panel, the 
National Institute of Mental Health, and the Secretary of 
Health and Human Services look very carefully into this process 
and support the healing of these children--at least the subset 
which is probably responsible for this large increase.
    Thank you very much.
    Mr. Burton. Thank you, Mr. Smythe. We appreciate you being 
here.
    Ms. Reynolds.
    [The prepared statement of Mr. Smythe follows:]
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    Ms. Reynolds. Mr. Chairman and Members, my name is Shelley 
Reynolds. I live in Baton Rouge, LA with Aidan, my husband of 8 
years, and my children, Liam, who is 4, and Mairin, who is 2. I 
would like to thank you both for holding this hearing and 
allowing me to testify before you today.
    I met Aidan in the 10th grade. We were in love with each 
other from day one. We dated all through college, and we got 
married as soon as we graduated. We had our own house, two 
cars, two careers, and two dogs. We were living the American 
dream.
    Right after we were married, Hurricane Andrew, one of the 
most destructive hurricanes to ever hit the United States, 
slammed through Baton Rouge. Sustained winds of 100 miles an 
hour ripped off our roof, and 8 days without electricity left 
us with very little food or water. We promised each other we 
would never again be unprepared for such a disaster.
    But 6 years later, hurricane-force winds blew into our home 
again. This time, the disaster was the diagnosis of autism for 
our first born son Liam. It completely tore our home apart, and 
the effects have lasted much longer than 8 days. No amount of 
preparedness can ready you for a storm such as this.
    Liam was a normally developing baby until June 27, 1997, 
when he received his MMR and Hib vaccines. He did everything he 
was supposed to do. He cooed, rolled over, crept, crawled, 
pulled up and walked on time. He said ``Mamma,'' he said 
``Daddy,'' he said ``Love you.'' He learned how to sing ``Itsy 
Bitsy Spider.'' He played finger games with us. He loved to 
interact, and he especially loved to show off for his 
grandparents.
    We did all the well-baby checkups on time. I breast-fed him 
until he was 8 months old. I did not start solid foods until he 
was 4 months old. We did everything completely by the book.
    But when he was 17 months old, shortly after he had 
received the shots, he started exhibiting some different 
behaviors. He was constantly taking off his shoes; he screamed 
if we dressed or undressed him; he would stare for hours in 
front of the television and would not move if you blocked the 
view. He could not tolerate playing in the sandbox anymore. He 
did not want to sing any of his favorite songs; he would cover 
his ears and scream ``No.''
    We assumed he was just asserting his independence, since he 
was almost 2. And somewhere along the way, he developed 
chronic, nonspecific diarrhea, sometimes 8 to 10 times a day, 
and still suffers from that 3 years later.
    By April 1998, I realized that Liam was no longer saying 
``Mamma'' or ``Daddy'' or ``Love you,'' so I took him for a 
speech and language evaluation. They told me that my 27-month-
old child had the language capacity of an 8-month-old. This was 
a child who only months before would chime in ``Ee-i-ee-i-o'' 
at the appropriate moment when singing ``Old MacDonald.''
    What had happened to our beautiful baby boy, and how could 
we help him? My husband and I decided to become advocates and 
work for increased funding for autism research and awareness. 
The answers may not come in time to help our son, but we are 
hopeful that we can persuade you to see the need for intensive 
research regarding this disorder which is affecting more and 
more children every year.
    In Liam's case, we have no doubt that he developed his 
autism as a direct result of an adverse vaccine reaction. And 
personally, if I could strike the belief that my son's autism 
sprang from a routine childhood vaccination, that I held him 
down on the table for and had to go back to the Russian 
roulette of genetics, I would take it in a heartbeat, because 
the pain of knowing that I inadvertently caused him harm due to 
blind trust in the medical community, or a matter of 
inconvenience of yet another office visit taking time away from 
my job is nearly unbearable.
    Many in the medical community continue to dismiss this as 
mere happenstance because autism often coincides with the time 
of vaccination, and state that there is no scientific evidence 
to back this up. My question to you is: How long does it take 
for a coincidence to surface time and time and time again, case 
after case after case, before it can become a viable 
hypothesis, especially when the solution to solving the problem 
seems so apparent? How can pharmaceutical companies concoct 
substances with mercury, formaldehyde, antifreeze, lead, 
aluminum, aborted fetal tissue and live viruses and not expect 
that as they continue to pour these highly toxic and reactive 
substances into children, increasing dose after dose, all on 
the same day, that it will not alter their minds and bodies?
    Why would it be so completely impossible for a child to 
contract a chronic form of the disease rather than to have the 
``proper immunologic response,'' especially if their immune 
systems are not up to par? And where is their scientific 
evidence to back up the claim that this cannot happen, when it 
is published in the very package inserts, in their writing, 
that they have not studied the effects of these vaccines for 
more than a few weeks, or longer than the incubation of this 
disease itself?
    What happens when you give multiple doses in 1 day or 
combine different diseases into one hypodermic needle?
    I need someone to explain to me why it is acceptable to 
have products on the market that exposed my son to 37.5 
micrograms of mercury in 1 day at a time when he should not 
have been exposed to more than .59 micrograms of mercury given 
his body weight. I should not be exposed to more than 5 
micrograms, and I have 31 years of an immune history behind me. 
It is completely unacceptable. One size does not fit all when 
it comes to vaccines.
    Through our organization, Unlocking Autism, we have talked 
with thousands and thousands of parents from across the 
country, and their story is the same: Child is normal; child 
gets vaccine; child disappears within days or weeks into the 
abyss of autism.
    If you doubt me, I invite you to come to the ``Hear Their 
Silence'' rally on April 8th on the Mall, where the ``Open Your 
Eyes'' project will be displayed and view the thousands of 
pictures that we have called and realize that 47 percent of 
those people who participated believe that vaccines contributed 
in some way to the development of their child's autism.
    Parents like me are relying on you to demand that the 
pharmaceutical companies retrace their steps once again and 
that the public health community look at the possibility that 
these things might indeed not just be a coincidence. They 
obviously have a forced market. They manufacture products that 
are required for every child in this country. We fear that it 
is possible that while seeking greater monetary profits, there 
may be some who have lost sight of the medical community's 
original goal regarding vaccinations--to protect children from 
harm.
    I know my children, and I know what happened to my son. As 
far as I am concerned, the needle that silently slipped into my 
baby's leg that day became the shot heard around the world.
    Thank you.
    Mr. Burton. Thank you, Ms. Reynolds.
    Ms. Smith.
    [The prepared statement of Ms. Reynolds follows:]
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    Ms. Smith. Mr. Chairman and Members, I am Jeana Smith. I 
live in Denham Springs, LA with my husband Darrell and our four 
small children--5-year-old genetically identical twins, Jesse 
and Jacob, 3-year-old Garrett, and 16-month-old Julianna.
    Darrell and I have always loved children, and we tried for 
over 6 years to have a child. We simply gave up on the idea 
that it was possible, and then I discovered I was pregnant with 
not one but two babies. I was completely overwhelmed.
    Perhaps because I had tried so hard to have a child, I took 
especially good care of my body while I was pregnant with the 
twins. Our identical twins were born right on time and were 
completely healthy. We were absolutely thrilled. Our family was 
perfect.
    One month later, we found dark blood mixed in with Jacob's 
diarrhea. Jacob had never had diarrhea before. We immediately 
took him to the doctor, who assured us that there was no 
problem. He mentioned that in the chaos that generally follows 
the birth of twins, we had been released from the hospital 
without them receiving their hepatitis B vaccine and wanted to 
give it to Jacob that day.
    I questioned him, because it did not seem right to give a 
potentially ill child a vaccine, but he convinced me that it 
was routine and safe and not to worry.
    Two months later, Jacob received his second hepatitis B 
vaccine and Jesse his first. On the same day, Jacob and Jesse 
both received their first DPT, polio, and Hib vaccination. From 
that day on, Jacob was constantly coming down with one ear, 
respiratory, or sinus infection after another. Jacob was 
constantly on antibiotics.
    As his mother, I was heartbroken to see him sick or in pain 
practically all the time. As a new mom, I was embarrassed and 
frustrated to have a child who was always ill. I knew I was 
doing everything I could for him, and I could not understand 
why he was constantly ill.
    Jacob met every developmental milestone that first year, 
right along with Jesse. They were two little peas in a pod and 
went everywhere together. At only 16 months of age, Jacob and 
Jesse received their first MMR vaccine. On this same day, they 
also received their fourth DPT, their fourth Hib, and their 
third hepatitis B. The following 24 hours, both twins slept 
most of the time, with over 100-degree temperatures, in spite 
of receiving the recommended Tylenol dosage every 6 hours. 
Immediately following that, Jacob began exhibiting strange 
behaviors. He was no longer excited or responsive when Daddy 
would come home from work. He began to become preoccupied with 
certain toys. He would spend long periods of time studying the 
way their wheels would spin or whether or not they were lined 
up just right. Any attempt to interrupt or distract him was met 
with great resistance and an eventual fit. During this time, 
Jesse continued to progress, starting to talk and interact with 
all the children around him.
    Back to the doctor we went again, but this time with even 
bigger concerns about the growing developmental difference 
between Jesse and Jacob. And once again we were met with the 
``dominant twin'' theory, that Jacob would probably be more 
quiet, Jacob would probably want to play by himself more often, 
and Jacob is fine, stop worrying.
    Finally, we would not stand the undeniable difference 
between their language and communication skills. Something was 
most definitely wrong with Jacob. He could not express even the 
most simplest needs or wants. He could not ask for juice or 
something to eat. Jesse was chattering constantly. And at 
times, Jacob was so withdrawn that we could absolutely not 
reach him.
    On days when Jacob is overloaded from sounds, colors, or 
lights, we cannot go anywhere. Autism not only isolates the 
individual whom it affects; it isolates the entire family. My 
husband and I have to go to the grocery store independently. 
When our other children have programs at school or birthday 
parties, one of us has to stay home, because Jacob cannot stand 
the outside stimulation. Our vacations have changed to only 
being able to go to the beach--no amusement parks, no baseball 
games, no family outings.
    Unlike most parents of an autistic child, I do not have to 
wonder what Jacob would have been like. I know what he would 
have been like. I see what he would have been like every day in 
Jesse's eyes. I see Jesse excelling in school and in social 
activities. I see Jesse excited about T-ball; I know that Jacob 
will probably never play T-ball and that he cannot attend 
birthday parties.
    For us, there is no denying that in Jacob's case of autism, 
the answer does not lie in genetics, but in a catalyst. The 
thousands of hours of research that we have spent searching and 
retracing his regression continue to point to the fact that the 
road of Jacob's autism began when his immune system was damaged 
by the hepatitis B vaccine he received when he was ill. The 
final blow was the adverse reaction to the host of vaccines he 
received 16 months later. We are certain that for Jacob, the 
catalyst was his vaccine.
    I cannot bear the thought that after waiting so long and 
being so careful carrying my twins, I was so easily persuaded 
to immunize Jacob without knowing all that I should. I should 
have taken the time to find out what his risk of contracting 
hepatitis B at only 1 month old was. I did not do that. I 
should have found out about all the toxic metals that are used 
to manufacture the vaccines. I did not do that. I should have 
known back then what I do today. I did not. I trusted his 
pediatrician. I trusted the CDC. I was persuaded to believe 
that I was doing the best thing I could to protect my child.
    No scientist, doctor, researcher or parent looking for 
answers or resources should never have to question where the 
funding will come from. It has to be here, and it has to be 
here now. I implore you to act now. Please--we do not have the 
time to wait for another hearing and another panel of parents 
and experts to advise us that this epidemic is waiting in the 
wings. We are swiftly and silently losing a generation of 
children to this disease that possibly could have been avoided. 
Please let this country be the leader in seeing the percentages 
of autism decrease and not increase.
    Every night, Darrell and I tuck two beautiful little boys 
into bed. On the outside, they look the same. Their pajamas are 
the same; their bed covers are the same. Everything on them is 
the same. They have the same ears, and they have matching toes. 
As Darrell and I sit in between their beds, we talk to Jesse 
about his day. He gives us all the details of his day at school 
and tells us everything he did with his friends. He talks about 
how excited he is for the next birthday party that will come 
this weekend. He talks to Darrell about working on his batting 
swing to prepare for T-ball in the summer.
    As he drifts off to sleep, we turn and look at Jacob. We 
know that even at only 5 years old, Jacob will never be able to 
enjoy the simple pleasures of childhood the way Jesse does. He 
will never be on a sports team. He cannot enjoy the fulfillment 
of a birthday party or friends. This difference is real. We 
know that Jacob's autism will not go away.
    When they fall asleep, we once again see two beautiful, 
matching faces. We know what should have been. It is the only 
time that their faces match. Even though they are identical, 
Jacob's countenance left when he was 16 months old. The light 
behind his eyes was replaced with a blank, lost, bewildered 
stare.
    Thank you.
    Mr. Burton. Thank you, Ms. Smith.
    [The prepared statement of Ms. Smith follows:]
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    Mr. Bono. Before I begin, I would like to give you the 
perspective of an autistic parent.
    Right now, I am more nervous about where my son is, because 
I do not see him, than I am about being before you today. That 
is a constant worry in the mind of a parent of an autistic 
child.
    My name is Scott Bono, and I live in Durham, NC with my 
wife Laura and my children, Dylan, Ashley, and Jackson. I have 
read the testimony and heard the stories of other parents in 
similar circumstances--change that to ``identical 
circumstances.'' Our story is not much different.
    We had a perfectly normal pregnancy and birth of our son. 
In the first 16 months of life, he learned language, played 
with toys, appropriately began pretending skills, initiated 
contact with his twin sisters, and could light up a room with 
his wonderful personality. He was brighter than most, and he 
could even tell the difference between a Concord jet and a 727 
at such an early age.
    On August 9, 1990, Jackson would begin a journey into 
silence, bewilderment, and a medical enigma. That was the day 
he received his MMR immunization. He would not sleep that 
night. In the days to follow, he would develop unexplained 
rashes and horrible constipation and diarrhea. After eating, he 
would experience projectile vomiting that would scare him.
    His normally very healthy body was being ravaged by an 
invader. Over the next weeks, he would slip away, unable to 
listen or speak. He retreated into what we now know as autism. 
He became allergic to everything in his world. His immune 
markers skyrocketed.
    What was the reason for this change? It is my sincerest 
believe that it was that shot.
    The single biggest challenge in raising an autistic child 
is getting appropriate, informed, and competent medical 
services. As I sit before you today, autism is, as it has been 
for decades, viewed as a psychological disorder. I cannot help 
but wonder about and get frustrated by the lack of medical and 
physiological intervention for all of these children.
    I live just 3 miles from Duke University Medical Center, 
yet for one of the most effective treatments for Jackson's 
gastrointestinal problems, I drive 12 hours for a procedure 
that takes 5 minutes. I have been doing this for the past 2\1/
2\ years and will be making this trip 13 times this year alone.
    To dismiss Jackson's acidic diarrhea for 7 years because 
``autistic children sometimes do that'' is just what happened. 
That is just unacceptable. As my son's advocate, I know that he 
is not receiving the medical treatment he needs, and I believe 
that as long as autism is regarded as a psychological disorder, 
this will always be the case. We need and seek responsible, 
effective and caring physicians who do not dismiss the 
patient's ailments as ``behaviors,'' but look at them as 
treatable medical conditions with appropriate medical 
intervention.
    This is what I believe to be the single biggest problem in 
getting group insurers to pay for medical services. Insurers 
must pay according to their contract. It is the law. But if a 
doctor says the visit to his office is for the treatment of 
autism when the autistic child is being seen for 
gastrointestinal distress, the insurer will not pay the claim. 
If, however, the diagnostic code for the visit shows that it is 
for gastrointestinal distress, the bill will be paid. The 
diagnosis of autism is used as a shield by some insurers to 
deflect the responsibility of paying for medical and remedial 
treatment for these children's medical problems.
    The expenses of seeing Jackson's needs are overwhelming--
hundreds of thousands of dollars over the past 8 years. After 
going through all of our savings and retirement, we continue to 
accumulate debt to meet his educational and therapeutic needs 
and his medical needs.
    Our priority right now is to get him well. There are other 
costs besides financial. Jackson is on a very strict diet that 
takes time and money. If he eats offending foods, he gets a 
rash, has diarrhea, and we will not sleep for the next 5 
nights. His behaviors will worsen.
    How do I put a cost on not sleeping for 6 years? How do I 
put a cost on attention not paid to my daughters because I am 
seeing to the needs of my son? How do I put a cost on locking 
every door and window at all times for fear of him wandering 
out of the house?
    Financial burden is only part of it. It is only part of the 
picture that families with autistic children face. If the price 
of eradicating measles, mumps, rubella, or any other illness is 
thousands of autistic children or health-impaired children, is 
it worth it? Have we simply traded acute illness for chronic 
disease? Is that worth the price?
    Autism has reached epidemic proportions, and the numbers 
are still growing. We must allocate funds to find the cause and 
the cure. The U.S. Department of Education indicates the 
increase in autism is 900 percent in the 8 years since 1992. If 
tooth decay went up 900 percent, we would be scrambling for 
answers.
    The statistics can no longer be ignored. Thousands of 
parents who claim their children were developing normally until 
the MMR vaccine should no longer be ignored. We all cannot be 
wrong.
    As elected officials, you hold the public trust, the 
essence of faith in Government. Your challenge is to uphold 
that trust.
    Thank you.
    Mr. Burton. Thank you very much, Mr. Bono.
    Dr. Dankner.
    [The prepared statement of Mr. Bono follows:]
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    Dr. Dankner. Honored committee members, fellow panel 
participants and members of the audience, I feel privileged 
today to appear before this committee to share my perspectives 
on autism, foremost as a parent but also from the additional 
perspectives as a pediatric infectious disease specialist and a 
scientist engaged in clinical research and evidence-based 
medicine.
    My daughter Natalie, who is over there, is now nearly 13 
years old, has autism, and has taught my family and me a lot 
about ourselves and how the world around us deals with 
individuals who appear different from the norm. She has been 
both a joy and a real challenge to live with, and we continue 
to live through these experiences every day, and I want to 
emphasize that.
    We have weathered this storm by rejoicing in her triumphs 
and finding humor in past events, even when those events may 
have seemed unbearable at that time. And I should add that my 
wife, unfortunately, is the one who has to bear most of these 
unpleasant experiences.
    We have found that our daughter's greatest needs have been 
in the area of education and for a highly structured 
environment to allow her some control over the events of her 
life. It is in the area of education that we have experienced 
our greatest challenge and have been labeled by our local 
school district administrators as the most difficult parents 
they have had to deal with. In the context of that meeting, we 
found this statement an insult, and there were other personal 
comments made to my wife that essentially have put her in a 
position where she will not talk to the school district 
administrators any longer.
    But we have been convinced by our friends and family that 
we should wear this as a badge of honor. If anything, it 
highlights the advocacy that we have championed for our 
daughter's right to an appropriate education that addresses her 
individual needs and the manner in which she learns best. I 
should point out that probably every parent on this panel is 
his or her own child's best advocate.
    My greatest hope today is that members of this committee 
and the audience will gain a better understanding of the unique 
nature of autism, the challenges and demands placed upon 
families caring for autistic children and adults, the 
significant emotional, financial, and community resources 
required to prepare and involve these individuals in everyday 
life, and to accept and respect these individuals for who they 
are.
    However, as previously mentioned, I also come to this 
committee as a trained infectious disease specialist and 
clinical scientist and, therefore, feel compelled to comment on 
two other areas of importance to me. In the area of medical and 
other treatments intended to help autistic children function to 
the best of their ability, I would hope to see more funding to 
allow for appropriately controlled and conducted studies to 
rapidly determine the true effectiveness of these interventions 
so that families can make informed decisions regarding the best 
use of their limited resources, as we have heard from a number 
of the panel participants already. Without these studies, I and 
other parents of autistic children are forced to make decisions 
which may at times prove disadvantageous to all involved, 
without the benefits of real data.
    I would also wish to comment on the current concerns 
regarding the potential causes for the perceived increase in 
autism. I implore the committee to be cautious in its 
statements and conclusions with regard to possible links to 
environmental factors and medical factors, especially 
immunizations. Recognizing that there are other parents on this 
panel who may feel otherwise--in fact, definitively feel 
otherwise--as a pediatric infectious disease specialist, I have 
seen no sound evidence linking autism to the MMR or any other 
vaccine, yet there is considerable evidence proving that the 
MMR vaccine is safe and highly effective in protecting children 
from serious diseases.
    In closure, no matter what conclusions are formed today or 
where the activities of these hearings may lead, I would like 
to share an axiom of medicine I have learned, practice daily, 
and continue to teach to future doctors: Above all, do no harm.
    Thank you.
    Mr. Burton. Thank you, Dr. Dankner.
    [The prepared statement of Dr. Dankner follows:]
    [GRAPHIC] [TIFF OMITTED] T9622.064
    
    Mr. Burton. First of all, I'll start with you, Dr. Dankner. 
Your daughter--whom I see sitting over there and is a lovely 
young lady--acquired her autistic condition--was this from 
birth?
    Dr. Dankner. No. She had the typical description that has 
been more commonly described of showing behaviors that became 
more and more obvious from about 14 to 18 months of age.
    Mr. Burton. When she was 14 months or thereabouts, did she 
receive any shots?
    Dr. Dankner. She received the normal vaccine schedule of 
immunizations as recommended by the American Academic of 
Pediatrics and the----
    Mr. Burton. What shots were those?
    Dr. Dankner. She received her MMR at about 15\1/2\ months 
of age.
    Mr. Burton. And when did she manifest or change?
    Dr. Dankner. She was manifesting subtle changes before 
that. It was obvious to us; we just did not know what to 
attribute it to at that time or what the issues were. We used 
to joke that compared to our older son, she seemed to be on an 
``independent study program.''
    Mr. Burton. Did she receive any other shots when you 
started seeing the manifestation of autism?
    Dr. Dankner. She had received her previous shots at about 6 
months of age.
    Mr. Burton. And had she received any others close to the 
time she started developing autism?
    Dr. Dankner. Not at that time, no.
    Mr. Burton. There were no other shots?
    Dr. Dankner. No, because at 12 months, essentially, you 
just get your PPD to screen for tuberculosis, which in 
California is potentially prevalent.
    Mr. Burton. When she started manifesting these signs, did 
she get worse after the MMR shot, or did it have any effect at 
all?
    Dr. Dankner. We did not notice any difference in her 
behavior; in fact, she got her second dose of MMR at about 5 
years of age, and there was definitively no change in her 
behavior after that. She pretty much continued on in her mode 
of autistic behavior that required, in our opinion, a 
definitive educational approach to address her needs.
    Mr. Burton. Thank you, Doctor.
    Mr. Bono, when did your child start manifesting signs of 
autism?
    Mr. Bono. Within about 30 days of the MMR.
    Mr. Burton. So when did----
    Mr. Bono. Quite honestly, when my wife had said, ``Don't 
you see?'' I think mothers have a much keener sense of 
behaviors with their infants.
    Mr. Burton. I understand, but what I am trying to find out 
is she received the MMR shot, and you and your wife started 
noticing a change----
    Mr. Bono. Indeed; exactly.
    Mr. Burton [continuing]. In 30 days, you said?
    Mr. Bono. Well, within hours of the shot, we went home, and 
there was no sleeping that night, and he had rashes on his 
body----
    Mr. Burton. And it got progressively worse?
    Mr. Bono [continuing]. And over the next week, there were 
gastrointestinal problems, and finally, full blown behaviors 
that were odd.
    Mr. Burton. And how old was your child when that started?
    Mr. Bono. I think it was right at 16 months.
    Mr. Burton. Sixteen months.
    Ms. Smith, when did your child start manifesting a change 
in behavior?
    Ms. Smith. Well, at 16 months when they received the host 
of multiple vaccines, including the----
    Mr. Burton. Which were what? What were all those shots?
    Ms. Smith. The DPT, the Hib--it was their fourth DPT, their 
fourth Hib, their third hepatitis B, and their first MMR on 
that day--they came home, they slept for 24 hours, most of that 
time, did not eat a whole lot, long periods of sleep, had over 
100-degree temperatures in spite of giving them Tylenol before 
the vaccine and during the entire 24 hours.
    After that time, I figured, well, Jacob is sick again, 
because he was just kind of out of it and did not seem real 
interested in much----
    Mr. Burton. But this was at about 16 months----
    Ms. Smith. Right, right.
    Mr. Burton [continuing]. That you started seeing the 
manifest change in the child with autism.
    Ms. Smith. Right. And when we did go to the pediatrician, 
they just passed it off as his asserting his independence.
    Mr. Burton. OK.
    Ms. Reynolds.
    Ms. Reynolds. Liam got his shot on June 27, 1997. That is 
when he got his MMR and his Hib. That was the day before he 
turned 17 months old. A week later, I went to visit my parents 
in Maryville, TN for July 4th, and we started seeing some very 
strange, different behaviors showing up then. He would not come 
when we called his name. He was doing weird pattern movements 
up against the wall--but it was within a week.
    Mr. Burton. So it was right after he received the MMR shot.
    Ms. Reynolds. Yes, sir.
    Mr. Burton. OK.
    Mr. Smythe.
    Mr. Smythe. At about 20 months, our son--I included in the 
record his vaccine schedule and my other children's, and 
interestingly, he was given hepatitis B the day he was born and 
then received the other two shots, one of them 30 days later, 
and another about 8 months later. He received 12 vaccines in 
the first 6 months, as the record shows, as compared to our 
other children who did not, in fact, receive the hepatitis B 
until a year after he received his third shot.
    Mr. Burton. When did he start----
    Mr. Smythe. Right after the MMR, at 20 months.
    Mr. Burton. At 20 months, right after the MMR.
    So you four people right here are all in concert that right 
after the MMR shot, you started seeing the manifest change in 
your children. Is that correct?
    Ms. Smith. Yes.
    Mr. Smythe. Yes.
    Ms. Reynolds. Yes.
    Mr. Bono. Yes.
    Mr. Burton. And your child, Mr. Curtis?
    Mr. Curtis. I guess I have to be the dissenting opinion on 
this end of the table. I do not really remember the specific 
day of Morgan's MMR shots or any of his immunizations. He did 
not really exhibit any behaviors--it was not anything that he 
did--it was what he never did. It was the fact that he never 
talked. And again, as I mentioned, it was a very gradual 
process. I think his idiosyncratic behaviors of lining up his 
toys and the self-stimulatory behavior, the flapping of the 
hands, the spinning, all really started after he was 2 years 
old. It seemed like once we had a word for it, then it almost 
got worse.
    We have thought about this a lot, because this is a very 
common theory. You read about it on the net, and you talk with 
other parents, and my wife and I have both discussed it at 
length, and we really do not see any correlation between the 
time of his immunizations and the onset of any specific or more 
intense behaviors.
    Mr. Burton. OK. My last question, then, would be did you 
notice shortly after his birth, as he was progressing, some 
problems then?
    Mr. Curtis. I think, yes. The reason I say ``I think'' is 
because we wanted to believe that he was a late talker, a late 
developer. The only thing we noticed was that he was not 
speaking and that he did not seem to react to the things that 
we did with him--but otherwise, he was a very normal, happy 
baby. He played, he interacted, he made lots of noises. He just 
never formed words and almost did not seem to react to our 
speech.
    For a long time, we were very concerned about his hearing, 
that maybe he did not hear properly. In fact, when his hearing 
was tested, in the first test, they said he was deaf, and once 
they did the brainstem test that was conclusive, it turned out 
that his hearing was absolutely fine; it was just that he was 
not reacting to sound or voice.
    Mr. Burton. Thank you, Mr. Curtis, very much.
    I want to yield--go ahead.
    Mr. Smythe. I am sorry. I also noticed that my son was 
given the DPT vaccines the same day he was given the MMR. So he 
got six vaccines on the same day.
    Ms. Smith. So did mine.
    Mr. Smythe. Yours did, also? OK.
    Mr. Burton. Thank you.
    Mr. Waxman.
    Mr. Waxman. It takes a lot of courage for all of you to be 
here, and I want you to know how much I appreciate it, 
especially when you are talking about something personal and 
painful. And, I know you are here to try to help us understand 
what you are going through so that we can try to find out about 
autism, and so that we can spare others from going through what 
you are going through.
    There is legislation--this committee does not have 
legislative authority; it has the ability to hold hearings and 
get information. But the committee that has legislative 
jurisdiction, which I am also on, is the Commerce Committee, 
and there, we have a bill, H.R. 3301, which incorporates 
legislation by Congressman Greenwood, Congressman Bilirakis. 
Both Mr. Burton and I are on that bill, and it would do a lot 
to research more about the prevalence and ways to deal with 
autism. I hope that will give us some of these answers that we 
so desperately want.
    Dr. Dankner, you are in a unique position. You are the 
father of an autistic child, and you are also a pediatrician 
and an expert on infectious diseases. But your testimony, is 
that you do not think there is sound evidence linking autism to 
the MMR vaccine. How can you say that when the other parents 
have given us evidence that, in their view, their children 
developed autism after the vaccine? Isn't that sound evidence? 
As a scientist, how do you think we should consider it, and 
what do we need to prove that there is a connection, if there 
is one?
    Dr. Dankner. One thing is that I am not here to invalidate 
the testimony of the other individuals. I know that from their 
heart, they feel that these events occurred in relation to a 
specific time and place, and it would be wrong for me to make a 
challenge to anyone on this panel. This is a personal issue for 
a number of these individuals.
    However, as a clinical scientist, when we do research--I 
take care of HIV-infected children--it is important to identify 
causal events so that we do not do, as I mentioned, harm on 
either side of the fence of any of these issues. And I think it 
is important that if this committee or the scientific world 
feels that there is not enough evidence to generate a causal 
link between vaccinations and autism or any other disorder, 
those studies need to be done and that people then should look 
at those studies in a critical view, with appropriate peer 
review, and all individuals who are purporting one position 
versus another should be able to stand under the light of 
appropriate peer review to ensure that the scientific 
information is collected appropriately, analyzed appropriately, 
and discussed in an open forum and not in closed sessions, to 
ensure that the best information is provided to everyone so 
that, again, best decisions can be made by individuals.
    I would like to bring a personal perspective as an 
infectious disease doctor. Unlike the other panel members, I 
have been on the other side of the fence and have seen children 
who have been harmed by vaccine-preventable diseases. I live 
close to the border, where the vaccination rate in Mexico is 
not the same as in the United States. I have seen children who 
have developed congenital rubella, a lifelong disabling 
condition. I have seen children die of measles during a measles 
epidemic in San Diego 10 years ago, even with the pretty 
reasonable vaccine rates for a highly transmissible disease. I 
have seen children suffer from pertussis, hospitalized at 
significant rates.
    That position puts me in a position of being cautious about 
making any links, because if the vaccine rates fall in the 
United States, I can almost guarantee from my own personal 
experience that there will be individuals who will suffer on 
the other side of the fence, and those are the individuals that 
this committee usually does not hear about.
    Mr. Waxman. I am not a scientist. I studied science at 
different levels of my education, and when I studied science, I 
was told that there is a scientific method to try to get 
answers, and the scientific method sometimes took a theory or a 
hypothesis and then tested it, and you had trials and control 
groups, and you tried to find out whether that theory is 
correct or not. Sometimes, theories turn out to be widely 
believed, but then they are discarded. We all studied the fact 
that in the past, people did not know about hygiene in 
connection with hospitals, which used to be among the most 
dangerous places to be because of the lack of hygiene.
    But you are a scientist--the others on this panel are 
parents--but from a scientific method, are you saying the 
theory is absolutely incorrect, or are you saying that we just 
do not know enough to say that it is correct?
    Dr. Dankner. There are other people who will testify today 
who I think can probably better answer that. I was asked to 
come on the panel both as a parent and as a scientist.
    My reading of what has been correlated to date does not 
appear to indicate a causal link. I think that debate has not 
been settled and probably needs to be, so that we do not 
continue to move down avenues that may be less productive in 
terms of the resources that are necessary to identify other 
potential links to autism, what the needs are in the community, 
which I can tell you are great----
    Mr. Waxman. Let me interrupt you because my time is up. Are 
you saying to us, in other words, that we should not be alarmed 
about vaccinations and have parents refrain from having their 
kids vaccinated because of this theory, which, at this point, 
you do not think has gone through a scientific evaluation to be 
established as scientific fact?
    Dr. Dankner. I think an alarmist view is always of concern. 
I am a cautious individual, and I think we just need to be 
cautious in how we approach this issue.
    Mr. Burton. Thank you, Mr. Waxman.
    Dr. Dankner, I hope that you will have the ability to stay 
and hear some of the other scientists' positions just for your 
own information.
    Dr. Dankner. I planned on it.
    Mr. Burton. Thank you very much.
    Mrs. Morella.
    Mrs. Morella. Thank you, Mr. Chairman.
    I am very moved by the testimony that I have heard and read 
today. You are indeed the heroes, and we see you as role 
models, and your children are very fortunate to have you as 
parents. So thank you for being here.
    I think the only question I want to ask is to Mr. Bono. 
When you said that you had to travel 12 hours for a 5-minute 
treatment--I do not know enough about the background to know 
what that treatment is, why you have to travel 12 hours for it, 
and how you found out about it.
    Mr. Bono. I have to travel 12 hours, but that is deceiving, 
and first let me apologize. It is 6 hours up and 6 hours back 
in 1 day, so it is 12 hours.
    Mrs. Morella. It is significant.
    Mr. Bono. I have to travel because the treatment is not 
recognized as helping my son, and it is not approved. It is 
secretin, and they call it a slow push, or an infusion of 
sorts. We found that going up about every 28 days is a real 
good cycle for Jackson. Without it, he will not have a normal 
bowel movement; he will have acidic diarrhea, and he will not 
digest food properly, he will have unexplained rashes.
    Mrs. Morella. Who advised you that this would help him in 
that area? Is there another doctor who made the suggestion?
    Mr. Bono. At the press conference, one of the doctors said 
that the parents have really been the ones in the forefront of 
finding treatment options for their children, and this was a 
parent, too. Her name is Victoria Beck, and she serendipitously 
discovered secretin working for her child as the result of an 
endoscopy.
    Laura and I had always thought there was some connection 
between the gut and the brain that needed to be bridged, and 
when we heard about Victoria's experience, we were rather 
fascinated, and we began to read about it, and that is how we 
arrived at that treatment.
    Mrs. Morella. Dr. Dankner, I just want to briefly ask you--
it is your daughter who is autistic, but in general, as I 
mentioned in my opening statement, there is a prevalence among 
males with regard to autism--are there some unique challenges 
that you face with a female rather than a male with autism?
    Dr. Dankner. Oh, yes, and those challenges are becoming 
more apparent now that she has achieved puberty. Luckily, she 
responds very well to sequenced pictures. One of the social 
stories that was provided to her through her school at my 
wife's insistence--and I have to admit that she has taken the 
forefront on this--is how to deal with menstruation. If you 
allow our daughter to do her own thing, she gets into a 
pattern, and that pattern becomes very difficult to break. And 
we have several holes in our wall for which we could probably 
pay a drywall person a pretty sum of money to repair when she 
gets mad at things, she will kick holes here and there. 
Luckily, we are having a room addition put on very soon, so 
that will take care of the last patch jobs that we did. That is 
one issue that came up.
    Another issue that my wife and I feel very concerned about 
is the risk for her to be sexually abused as she gets older 
because of her inability to really indicate or express 
interactions with other individuals, as a number of the other 
panel discussants talked about with older children. Our 
daughter comes home from school, and you can ask her how her 
day went, and she will say ``Fine,'' but you will not be able 
to--unless we are given a set of things that went on at school, 
she is not there to carry on small talk; that is not a major 
impetus in her life. She will interact with us because she has 
needs, and she will seek us out for those, but if left to her 
own devices, she will stay in her garage room, watch her TV, 
whatever video she finds the most appealing that day, and she 
loves to play with the reverse and replay buttons on a regular 
basis.
    So, yes, I think there are some special challenges, but I 
think there are challenges for males growing up with autism 
also. There are things that they are going to have to face as 
they get older, and as they get older, I think the challenges 
become different. And I think all of the parents have to deal 
with the issue of what is going to happen to their children as 
they get older, who is going to take care of them when the 
parents are beyond an age when they can no longer take care of 
these children.
    Mrs. Morella. The toll on parents is immeasurable, 
obviously. Thank you.
    Thank you, Mr. Chairman.
    Mr. Burton. Thank you, Mrs. Morella.
    Mr. Turner, do you have any questions?
    Mr. Turner. Thank you, Mr. Chairman.
    Doctor, I just have one question for you, and I know this 
hearing centers on the problem of autism. The chairman has had 
personal experience with it in his family, and I know that he 
has also had some experience with a granddaughter with the 
hepatitis B vaccine.
    I just wonder--is there any reason to question the age at 
which some of these vaccines are administered? I have always 
had the feeling that the younger the child, the more fragile, 
and therefore, the negative impact, if it be there, the 
potential is certainly greater when those vaccines are 
administered at an early age.
    I have, of course, had particular interest in the hepatitis 
B vaccine which is administered, I think, in most States now at 
birth, routinely. In fact, I was in the home of a family in my 
district this weekend who have a 2-year-old child who is 
severely disabled, and basically, this family spends most of 
their waking hours tending to the child, and they strongly 
suspect that the problem is the result of a hepatitis B 
vaccination. That is administered at birth, and I have been 
told that there is really no logical argument for trying to 
vaccinate a newborn, because the threat of hepatitis B does not 
exist at that early an age, but it might be a more appropriate 
vaccine for later in childhood or approaching the teenage 
years.
    Is there any reason to question the timing of some of these 
vaccines? One of our witnesses today talked about the large 
number of vaccines administered at one time.
    Dr. Dankner. Again, I was not called to the panel, I think, 
to give a long explanation of vaccine policy. There are lots of 
other individuals who have been involved in those policymaking 
decisions over the years. But I can give you my perspective 
once again from the diseases that we see in these age groups.
    Albeit hepatitis B is an uncommon disease process that 
children may or may not get exposed to, the more likely 
exposure is going to occur when they reach sexual debut, as we 
call it, when they can easily be exposed to hepatitis B from a 
partner. That is one of the major concerns, and hepatitis B is 
a major cause of chronic liver disease in the United States and 
has reached a rate where vaccination would definitely have an 
impact on that disease in terms of its prevention.
    The reason for giving some vaccines earlier is just to 
ensure that the vaccination gets performed. Rubella is a 
perfect example. When congenital rubella was identified in the 
United States, Australia and Europe as a devastating disease 
linked definitively to the acquisition of rubella by mothers 
who were previously uninfected, with no previous immunity to 
rubella, the approach was taken differently by different 
nations. If you look at the United States, they focused on 
giving the rubella vaccine early in life so that you would 
eliminate the pool of individuals who were exposing adults to 
rubella, whereas England took the approach of trying to 
vaccinate adolescent females primarily, because they were the, 
``at-risk population'' who could transmit rubella to their 
unborn fetus. The experience in England was that it took them a 
lot longer to eliminate congenital rubella from their 
population, and the experience in the United States was an 
enormous success, because even though you had women who were 
susceptible to rubella, they were not being exposed, and as 
those children who got the rubella vaccine early in life aged 
up into their childbearing years, they were no longer at risk 
of developing congenital rubella. The result is that the United 
States sees probably about two, four, five cases of congenital 
rubella a year, and most of those are from individuals who have 
either not received vaccination or come from a foreign country 
where the vaccine rates are much lower.
    Additionally, the hemophilus influenza B vaccine, the vast 
majority of H-flu meningitis that we see occurred in children 
less than 24 months of age. If you wait until they are 2 years 
of age to give the vaccine, you have missed the peak period. We 
used to see at our Children's Hospital in San Diego 60 to 70 
cases of hemophilus influenza meningitis per year. That is a 
pretty devastating disease for most of the children. We see 
essentially one case about every 2 or 3 years now, and the last 
case we saw was in a mother who had her fourth child and just 
did not get to the doctor to get the H-flu vaccine.
    I think that if you want to ask about the policies, you 
will need to talk to the policymakers for their conclusions. I 
can only give you my viewpoint from the standpoint of how I see 
infectious disease and the impact that I have seen in our local 
community, and the diseases that I no longer see, which some 
doctors in practice now may never see again, I think to the 
advantage of those particular children who are not suffering 
from those particular diseases.
    To be fair to the other panel participants, I recognize 
that I am a physician and I bring certain issues to the table, 
but I think the other individuals also have a lot to say that 
needs to be heard, and I do not want to monopolize everyone's 
time.
    Mr. Turner. I appreciate your comments. I guess the only 
point I was trying to make, and perhaps the witnesses on our 
second panel will help us with it, is that there are obviously 
good public policy reasons to have the vaccines given, but at a 
minimum, if the timing of those vaccines could be later in life 
for children, it seems that at least we owe the public that 
information, because particularly in the case of hepatitis B, 
if the threat of hepatitis B only occurs at the time when the 
child has the potential of becoming sexually active, it does 
not make a lot of sense to have a public policy that says we 
administer it on the second day of life; and if there is a 
risk, I as a parent certainly would not want that vaccine 
administered to my child at that point in time. People need to 
have that information.
    Thank you so much, Doctor.
    Mr. Burton. The gentleman's time has expired.
    Mr. Turner. Thank you, Mr. Chairman.
    Mr. Burton. Thank you very much, Mr. Turner.
    Mr. LaTourette.
    Mr. LaTourette. Thank you, Mr. Chairman, and thank you, Mr. 
Waxman.
    I want to thank each of you for sharing your families' 
experiences with us today. Ms. Smith, my wife and I are the 
parents of 8-year-old twins, and we always said that if the 
twins had been first, they would have been last, because 
raising twins is enough of a challenge all by itself.
    I was not going to talk about what my friend from Texas was 
talking about, but it always amazed me--and I am not smart 
enough to know the connection between vaccines and what brings 
you here today--but it always amazed me that after these 
vaccines, you would bring your baby home, and he would turn 
bright red and have a horrible fever, and they would say, 
``Well, you just have to hang on for a little while, and 
everything is going to be OK,'' and this was a drug which was 
going to prevent some horrible childhood disease in the future. 
But why they were being exposed to these vaccines within the 
first couple days of being born, or even the first few months 
of being born, is something that I do think we need to get a 
handle on.
    But Ms. Smith, I want to talk to you about a portion of 
your testimony, and Ms. Reynolds also, because if I understand 
it, you may be following similar paths. That is, you have had 
Jacob screened and tested for the presence of heavy metals and 
fungi and other foreign substances within his system, and he is 
currently undergoing some nutritional therapy and so on. I 
wonder if you could share those experiences with us. And I 
think it was you, Ms. Smith, who wrote that the results of that 
screening were shocking and that it was amazing--was it you who 
had Dr. Stephanie Cave----
    Ms. Smith. Yes. We both----
    Mr. LaTourette. You both had Dr. Stephanie Cave.
    Ms. Smith. Right.
    Mr. LaTourette. OK. Then, maybe one at a time or in tandem, 
you could tell us a little bit about Dr. Cave's work and what 
about the results of these screenings was shocking, and what 
sorts of things now Liam and Jacob are going through that give 
you hope and point in the direction that this is a biomedical 
condition rather than a neurological condition.
    Ms. Smith. In my case, it is clearly not a genetic issue, 
considering that they are identical. The other reason I do not 
feel that it was a neurological disorder that he was born with 
is because his descent into autism happened so rapidly. He was 
completely with me, and he descended into autism so rapidly, 
and to me, that is not a neurological disorder that he had at 
birth.
    Also, I feel that it was not a neurological disorder that 
he was born with because when he was 2\1/2\, we had several 
professionals recommend that we put him on medications. I do 
not know what medications they said, such as Ritalin--I never 
pursued that avenue, because I felt like medicating a 2\1/2\ 
child was simply not good enough when I did not know what his 
body was already doing.
    I went to see Dr. Cave, and she ran blood and urine tests 
and took stool samples to see what deficiencies he had, the 
areas that he was lacking in, his amino acids and so on. We 
found that he had 10 food allergies. Because he had been on 
repeated antibiotics, he had extremely high--out of 23 fungal 
and yeast infections, he was high in 20. He was chromium, zinc, 
magnesium and copper deficient. He was B5-deficient. So, 
basically, what we did was we immediately started taking out 
what was bad and putting back what was good and taking him off 
the foods that he was allergic to. And within 5 days, my son, 
who had only a couple of words in his language and was very 
lost, said a full, appropriate sentence and started speaking 
again.
    So the rapid improvement also shows me that this was not a 
neurological disorder in his case.
    Mr. LaTourette. OK. And Ms. Reynolds, is Liam also 
undergoing similar therapy?
    Ms. Reynolds. Yes, he is. When he was diagnosed in May 
1998, we put him on a strict, gluten-free, casein-free diet 
that Dr. Cave prescribed, where he was not allowed to eat any 
of the substances, because his body was taking those things and 
actually manufacturing morphine, which was what was making him 
just sit and stare and not respond appropriately to things.
    Since that time, he has undergone an MRI, EEGs, all the 
normal things that they run on autistic children, and those all 
point to normal things. But when you start doing blood work and 
stool work and urinalysis, and they measured for toxic metals 
in his hair, she suggested that we give him a medication that 
would help pull out the heavy metals that he had been exposed 
to, and my husband and I were so gun-shy at this point from 
dealing with doctors that we pulled out the PDR and read 
through it, and we were, like, ``I do not know, this sounds a 
little weird to me; I do not think we are going to try this.'' 
And we took Liam to an environmental toxicologist who did some 
blood work and told us that the shape of Liam's blood--he had 
stippled cells that would be the same as a plant worker who had 
had serious toxic heavy metal exposure and that our son's blood 
cells were malformed as a result of heavy metal exposure that 
he had received.
    We have given him this medication several times. We were 
able in December to get a good urine sample, which is a little 
challenging around our house, and we were finally able to test 
that. The normal range--and I am probably going to mess this 
up--but the normal range for anything to show up in their 
bodies is between zero and six, and his lead and mercury had 
reduced down to normal ranges, but his levels of tin were 
completely off the charts. They were not even measurable. They 
were up around 250.
    Mr. LaTourette. Did you say tin?
    Ms. Reynolds. Tin.
    Mr. LaTourette. If I could just beg the chairman's 
indulgence, is he likewise receiving, aside from the medication 
that you are talking about, a nutritional program?
    Ms. Reynolds. He receives a number of nutritional 
supplements every day. He is on an antifungal medication, 
because we have been dealing with a yeast infection that just 
will not go away for 3 years, that makes him just a real mess. 
He is just a walking biological nightmare. And he looks as 
healthy as a horse. He has great skin, he has great teeth and 
cheeks. He is a beautiful, beautiful little boy, but if you 
take it down to the cellular and the molecular level, you can 
see that this child is a total mess.
    Mr. LaTourette. Thank you very much.
    Thank you, Mr. Chairman.
    Ms. Reynolds. You are welcome.
    Mr. Burton. Thank you very much, Mr. LaTourette.
    Ms. Biggert, did you have any questions?
    Ms. Biggert. No questions, Mr. Chairman.
    Mr. Burton. Well, let me thank this panel. I just want to 
say to the four of you who have experienced this change right 
after the MMR shot that my daughter is sitting back there, and 
I and my daughter experienced exactly the same things that you 
did, and I believe what you are saying, and we are going to 
pursue that as diligently as possible, because I cannot believe 
that it is just a coincidence that the shot is given, and 
within a very short time--he got nine shots in 1 day, the MMR 
and DPAT, HIB and oral polio--and within a matter of just a few 
days, instead of being the normal child that we played with and 
talked to and everything else, he was running around, banging 
his head against the wall and flailing his arms.
    When people tell me that that was a genetic problem, I am 
telling you they are just nuts. That is not the way it was.
    With that, I want to thank this panel very much. We will 
now go to our next panel.
    Thank you very much.
    We now welcome our second panel to the witness table. This 
panel consists of: Dr. Andrew Wakefield, who came all the way 
from merry old England, and we appreciate him being here; 
Professor John O'Leary, whom I am sure you will notice after he 
starts talking is from Ireland; Dr. Vijendra Singh, I 
appreciate you being here; Dr. Coleen Boyle, Dr. Paul Offit, 
and Dr. Brent Taylor.
    Would you all please rise and be sworn?
    [Witnesses sworn.]
    Mr. Burton. Please have a seat.
    Dr. Wakefield, would you like to start this panel?

 STATEMENTS OF DR. ANDREW WAKEFIELD, ROYAL FREE AND UNIVERSITY 
  COLLEGE MEDICAL SCHOOL, LONDON, ENGLAND; DR. JOHN O'LEARY, 
 COOMBE WOMEN'S HOSPITAL, DUBLIN, IRELAND; VIJENDRA K. SINGH, 
  UTAH STATE UNIVERSITY; COLEEN A. BOYLE, CENTERS FOR DISEASE 
  CONTROL AND PREVENTION, U.S. DEPARTMENT OF HEALTH AND HUMAN 
  SERVICES, ACCOMPANIED BY DR. BEN SCHWARTZ, ACTING DIRECTOR, 
EPIDEMIOLOGY AND SURVEILLANCE DIVISION, CDC; DR. PAUL A. OFFIT, 
 UNIVERSITY OF PENNSYLVANIA SCHOOL OF MEDICINE; AND DR. BRENT 
   TAYLOR, ROYAL FREE AND UNIVERSITY COLLEGE MEDICAL SCHOOL, 
                        LONDON, ENGLAND

    Dr. Wakefield. Yes, thank you, Mr. Chairman, members of the 
committee. It is a great privilege to be here.
    The purpose of my testimony is to report the results of the 
clinical and scientific investigation of a series of children 
with autism. Nothing in this testimony should be construed as 
anti-vaccine; rather, I advocate the safest vaccination 
strategies for the protection of children and the control of 
communicable disease. I am also here on my behalf representing 
the children who have come to me for investigation.
    I would like you to look at the screen if you would, 
please, and I will take you through the presentation.
    Next slide, please.
    Just as a little bit of background, this represents 12 
years of intensive clinical and scientific research, 
collaborative research, into the causes and mechanisms of bowel 
inflammation. I am a gastroenterologist.
    The principal authors of this work have contributed to over 
1,500 peer-reviewed and published scientific papers and 
abstracts. Again, these represent my views.
    Next slide, please.
    I want to report the results today from the first 60 
children that we have investigated. We have now investigated 
over 150 children, and the results that I am going to describe 
are pertinent to all those children bar about four.
    As far as the range of psychiatric assessments, the great 
majority had autism, but there was a spectrum of 
neuropsychiatric problems including Asperger's Syndrome and 
Attention Deficit Disorder. By far and away the most important 
investigation has been direct visualization of the bowel and 
taking biopsies by the procedure of ileocolonoscopy. This is a 
flexible instrument introduced into the bottom end to take a 
biopsy.
    Next slide, please.
    What you have heard this morning is a classical description 
of two different types of autism from the parents. You have 
heard about the children that we have seen, those who have gone 
off after a period of normal development, many of them in the 
face of multiple vaccine exposures with severe gastrointestinal 
symptoms.
    The other type, described very articulately, was of an 
insidious failure to acquire skills at an extremely important 
point. The essence of what I am going to present today is based 
upon conventional clinical medicine. It is listening to the 
patient.
    Here is a child who was entirely normal for the first year 
of life and went off a week after receiving his MMR vaccine. He 
is exactly as the four children were described earlier.
    Next slide, please.
    The classical features in these children are pain--there is 
a radiograph here of the abdomen, and there is fecal impaction. 
When these children came to us, the feature was of diarrhea, 
but in fact this turned out to be what we call spurious or 
overflow diarrhea. There was soiling, loss of contents, 
fastidious eating habits, reflux and nighttime wakening. They 
get heartburn, and they wake up very distressed. These symptoms 
are the same wherever you go. If I listen to parents from 
Canada, from the States, from Europe, and from Australia, the 
story is the same.
    Next slide, please.
    The associated features that we have in these children are 
of atopy--asthma, eczema, and hay fever. There are refractory 
upper respiratory tract infections. They do not deal well with 
common childhood infections, colds, and there is a very high 
level of autoimmune disease in the family--thyroid disease, 
diabetes, for example.
    Next slide, please.
    This is the insider's view of the small intestine. The 
panel on the top left is of what it should look like in a 
child. The bottom left of is lymphoid nodular hyperplasia. 
There is a swelling of the lymph glands in the bowel. These are 
rather like tonsils, and when they swell, they cause pain and 
symptoms.
    Mr. Waxman asked about the reproducibility. He is 
absolutely right. Up on the top right-hand panel, you see a 
child who was scoped in the United States with exactly the same 
symptoms. So this is reproducible in two different continents. 
We have compared it with controls, and the graph on the bottom 
right shows that even children who come to us with 
gastrointestinal symptoms who are scoped, the finding of 
lymphoid nodular hyperplasia is relatively uncommon. In the bar 
on the left, 85 percent of them show no evidence of it, but 
virtually all of our autistic children show evidence of 
lymphoid hyperplasia, either mild, moderate, or severe.
    Next slide, please.
    There are histological changes under microscopy which show 
there is a definite disease. The top left-hand panel is normal; 
the bottom right-hand panel, for example, shows what is called 
a crypt abscess, that is, puss in the bowel wall, and this is a 
feature that we see in children and adults with ulcerative 
colitis. There is a clear and demonstrable, albeit subtle, 
pathology.
    Next slide, please.
    A further paper that is due to be published soon has taken 
this to one further level and asked is this disease distinct 
from classical inflammatory bowel disease, Crohn's and colitis, 
or is it something new. And the data, at least, so far, suggest 
that it is something new.
    Next slide, please.
    We have described this feature in the gut, lymphoid 
hyperplasia, and colitis in children with autism. From this 
same city, from Georgetown University, Professor Joe Bellanti 
has described it in children with attention deficit disorder, 
coming back to the question, is this a spectrum of disorders 
which have at their heart some gastrointestinal abnormality.
    Next slide, please.
    Lymphoid nodular hyperplasia classically occurs in the 
presence of immunodeficiency. We do see it during acute 
infection, but it is classically associated with 
immunodeficiency. Are our children immunodeficient? As a group, 
the answer is yes, they are.
    This graph just shows you a particular count of a certain 
type of immune cell in the blood. The green line is the upper 
limit for normal, the red line is the lower limit for normal, 
and each blue dot represents a child. You can see that the 
great majority sit at or below the lower limit of normal. Not 
only are they numerically deficient, their immune system does 
not respond appropriately to common recall antigens when 
compared with normal age-matched children. In other words, if 
you give them a skin-prick test for pertussis or diphtheria, 
they mount no response.
    Next slide, please.
    So the key features of the syndrome are developmental 
regression, ileocolonic lymphoid hyperplasia, swelling of these 
tonsil tissues, enterocolitis--that means inflammation of the 
small and large intestines--and immunodeficiency.
    Next slide, please.
    So it is a real syndrome, there is a remarkably consistent 
pattern of bowel inflammation, and it provides us with vital 
clues. What are those clues?
    Next slide, please.
    The story as told to us and which we have an obligation to 
report is that the majority of children regressed following a 
period of normal development in the face of MMR vaccination. 
That does not mean it is the cause of the disease.
    We also had two children who regressed after classical 
measles infection--one after the monovalent measles vaccine and 
one after a rare vasculitic rash. Thirty-six percent of parents 
could contemporaneously identify no particular environmental 
hit.
    Next slide, please.
    Have measles and common childhood infections been linked to 
autism before? Is there a reason to go into this and look at 
it? The answer is yes, there is. There is a paper that came 
from the Harvard School of Public Health, and it showed that 
atypical patterns of exposure to common childhood infections--
measles, mumps, chicken pox, rubella--were a risk for autism in 
the child. By ``atypical,'' I mean maternal exposure when 
pregnant or neonatal exposure.
    What was intriguing about this, which we may come to later, 
is that if you were a pregnant mother who was exposed to more 
than one of these common infections at the same time, or 
indeed, an infant child, then your risk of autism was both 
greater, and the severity of the autism was greater. Question: 
Was there a compound effect of more than one infection?
    It has also been shown that children born in and around 
epidemics of measles and rubella have higher rates of this 
disease.
    Next slide, please.
    What about vaccines? There is a paper from the Vaccine 
Damage Compensation Board in the United States--acute 
encephalopathy followed by permanent brain injury or death 
associated with further attenuated measles vaccine. What was 
intriguing in this cohort of children who fulfilled rather 
strict criteria was that 43 out of 48 underwent developmental 
regression as part of their syndrome. So we have this other 
pattern of exposure to measles as the further attenuated 
vaccine children undergoing developmental regression.
    Next slide, please.
    To summarize, unusual patterns of exposure to common 
childhood infections are associated with autism and 
developmental regression.
    Next slide, please.
    Here is the clue. This is the important image, and here, 
you see the insider's view again--these swollen tonsilar 
tissues. If you are looking for an infection, this is where you 
should be looking.
    Next slide, please.
    When you look down the microscope, this is what that 
swollen tonsil tissue looks like, and you are looking in the 
center of that for the infection. This is a response to a 
foreign agent, a foreign antigen, usually an infection. So if 
you are looking for the cause of that, that is where you are 
looking.
    Next slide, please.
    This is a very high-powered micrograph of a single cell 
called a follicular dendritic cell, and this is crucial, 
because if you are looking for the source of that infection, 
not only are you looking in that lymphoid follicle, not only in 
the center of the lymphoid follicle, but in this specific cell.
    Next slide, please.
    When we look in that specific cell using an antibody which 
picks up measles protein and only measles protein, we find it 
in that cell. We do not find it in other cells or other tissue, 
we find it in that cell.
    Next slide, please.
    You look for other viruses. You ask the question: Is this 
just a nonspecific response? Do we find other viruses in there? 
So you look for adenovirus, herpes simplex I and II, rubella, 
mumps, HIV, and other crucial controls that Mr. Waxman referred 
to early, and you do not find them. They are not there.
    So at least within the context of this study, this appears 
to be specific for measles virus.
    Next slide, please.
    The next question: Is there an antibody; is there an immune 
response to the virus in these children? The mere presence does 
not make it the cause. Is there an immune response?
    We take the autistic children, and we compare them with 
age-matched controls, and we look at measles antibody titers. 
We also look at controls of mumps, rubella, and cytomegalur 
virus, or other common childhood infections. The only one for 
which there is a statistically significant difference between 
the cases and the controls is for the measles virus.
    Next slide, please.
    We had failed completely to identify this virus by 
molecular amplification technology. In my laboratory, we had a 
reaction that was sensitive to about 10,000 copies. Anything 
less, we could not find it.
    The Japanese had succeeded, so we sent nine blood samples 
from our children to the Japanese laboratory, and we also sent 
21 other patients. We mixed them up. We did not tell them what 
they were getting. They just had a control label. And they 
identified measles virus in three of those nine children in the 
peripheral blood. That is an intriguing finding. This is 
consistent with; but not definitely, vaccine strain. One can 
only say that this is consistent with, but there it is, and 
this was a blinded control study.
    Next slide, please.
    Very briefly, to finish up, what is the link between the 
gut and the brain? This is one of the most difficult things for 
people to understand. How can the gut influence the brain? I 
come from a liver unit where we see patients with chronic liver 
failure, acute liver failure, all the time, and one of the 
classical manifestations of that--next slide, please--is 
hepatic encephalopathy. This is where the liver is damaged, is 
diseased, and fails to degrade the chemical constituents of the 
bowel that come through. It fails to mop them up and clear them 
out; they impact upon the brain. This is largely reversible. If 
you are hit with these for long enough, it becomes 
irreversible.
    The question is, therefore--at least we have biologically a 
plausible hypothesis, a testable hypothesis that elements from 
the gut, undegraded chemicals from the gut, including the 
opiods that were referred to by Shelley Reynolds, may be 
getting through, may not be metabolized, may be impacting upon 
the rapidly developing brain during the first few years of life 
and producing residual cognitive deficit, which we recognize as 
autism.
    Next slide, please.
    So finally, in summary, we have an environmental insult in 
perhaps a genetically susceptible child. The problem is that if 
you go to Sweden now, autism affects over 1.2 percent of the 
pediatric population. So if there is a genetic background, it 
is clearly widely distributed within the population. We believe 
that in many children, clearly, the subset of autistics, it 
leads to gut infection and damage; that leads to an ingress, an 
impaired metabolism, degradation of these chemicals from the 
gut which then get through and impact upon the brain. And the 
disregulated immune system which measles classically can 
produce also encourages immune diseases, atopic diseases, and 
immuno disregulation.
    Thank you, Mr. Chairman.
    Mr. Burton. Thank you, Doctor.
    Professor O'Leary.
    [The prepared statement of Dr. Wakefield follows:]
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    Dr. O'Leary. Mr. Chairman and members of the committee, the 
purpose of my testimony is to report the scientific results in 
a series of children with autistic enterocolitis that has just 
been described to you. Nothing in my testimony should or must 
be construed as anti-vaccine; rather, it encourages safe 
vaccination strategies. The opinions that I am expressing in 
the text and in my presentation are those of my own.
    These studies were undertaken following an approach made to 
me by Dr. Andrew Wakefield, who has just submitted independent 
testimony. The studies represent a transnational, 
multidisciplinary research program aimed at elucidating the 
causes and pathogenesis of inflammatory bowel diseases in 
association with developmental disorders of childhood.
    Next slide.
    Dr. Wakefield has alluded to measles virus as a potential 
associated factor in the pathogenesis of autistic 
enterocolitis, and he came to our laboratory to seek molecular 
confirmation.
    Next slide, please.
    He posed some questions. The first question: Was measles 
virus present in gut biopsies from these children?
    Next slide, please.
    Where was it located? How much was there? Could it be 
sequenced--could we actually confirm there was measles virus? 
And finally, could different molecular technologies actually 
independently confirm the presence of measles virus?
    May I inform you that I am a pathologist and a molecular 
biologist. My area of diagnostic expertise is histopathology, 
which is understanding and examining the cellular basis of 
disease.
    Next slide, please.
    The blinded study included 46 cases; 25 children had a 
diagnosis of autistic enterocolitis, and 21 controls were 
included in the study, including 15 normal children who did not 
have a developmental disorder, four children with Crohn's 
disease, which is a chronic inflammatory bowel disease 
condition, and two children with ulcerative colitis, a very 
similar condition but one which is histologically different.
    We examined terminal ileal biopsies, and from the blocks of 
tissue that were given to us, we looked at four to six serial 
sections on the one case. What we wanted to do was to see if we 
could identify the virus; could we replicate it on multiple 
sections from one patient. Where available, fresh tissue was 
examined.
    Next slide.
    The positive control materials in this study were 
transvected measles virus-infected viral cells which contained 
measles virus genome, and measles virus-infected brain tissue. 
As negative controls, we screened a panel of other virally 
infected cells lines.
    Next slide.
    To confirm the presence of measles virus, we adopt a five-
hit strategy. The first was to localize and identify the 
presence of measles virus RNA in the tissue sections from these 
patients.
    The second was to quantify using a technology called TaqMan 
real-time quantitative PCR. I have worked in this technology 
for the last 6 years, and it is approximately 1,000 times more 
sensitive than existing PCR-based technologies.
    Finally, we wanted to confirm the sequence of the virus, so 
we employed capillary fluorescent-based sequencing.
    Next slide.
    Let me summarize what in-cell PCR is. I know this is 
technical, but I think it is extremely important. Measles virus 
is an RNA virus, and RNA when it is removed from the body is 
extremely easily degradable. PCR basically is like a 
photocopying reaction. We can make multiple copies of a 
particular gene that we are interested in looking for.
    In-cell PCR allows us to demonstrate these genetic 
sequences in cells and without cells, looking down the 
microscope.
    Next slide.
    TaqMan quantitative PCR basically is a revolutionary PCR-
based technology which is sequence detection-specific. You will 
only get a positive result in this assay if the desired gene of 
interest that you are looking for is present in the tissue 
section.
    Next slide.
    In our laboratory, we are one of the few laboratories in 
the world that actually perform RNA inhibition assays. This is 
effectively to test how degraded the RNA in our samples is, and 
No. 2, is there anything in the environment of the laboratory 
that is contributing to the breakdown of RNA in tissue samples 
of cells.
    Next slide.
    I think it is extremely important in relation to the 
detection of low-copy viral infections, and I think our 
laboratory has a reputation for the detection of low-viral copy 
numbers, that we have strict anti-contamination measures. What 
I mean here is that we do not want to generate false-positive 
results.
    So we have separate, isolated extraction and PCR areas. 
This is in a newly built, custom-designed molecular biology 
facility. We have two independent laboratory sites, and for the 
purpose of this investigation, we employed in situ 
hybridization, which is basically a way of taking a cloned or a 
fragment of DNA or RNA that you have in your laboratory and 
looking for the presence of that in a tissue section or cell. 
We can use the technology of in-cell PCR that I have described, 
solution phase PCR, and TaqMan PCR, which are complementary 
technologies, but TaqMan PCR is 1,000 times more sensitive than 
standard solution phase PCR technologies, and then sequencing.
    Next slide, please.
    Just to reiterate again the point: Our laboratories go to 
desperate lengths, No. 1, to prove that we do not have RNA 
inhibition, but second to prove that we do not have 
contamination. We purposely in all of our plates set up 
contamination. This is effectively to outrule the possible 
generation of false-positive results.
    Again, I would appeal to the non-scientific members of the 
committee that this is an extremely important control that must 
be included if you are looking for low-copy viral gene 
detections.
    Next slide, please.
    And of course, to confirm the presence of measles virus, 
the gold standard is to confirm the sequence of the virus, to 
say yes, this is measles virus RNA that we have got in the 
tissue sections.
    Next slide, please.
    Let us look at the results now. We carry out an extensive 
set of optimization reactions where we had measles virus 
clones, looking at several regions of the measles virus genome, 
F, N, and H. The technical detail of this is not important, but 
just to show you that we could look at several genes within the 
measles virus genome, and we could reproducibly make copies of 
these or amplify them.
    The bottom panel shows you an experiment which allows us to 
detect the measles virus in viral cells, showing what the 
optimal concentration of the probe that we require to detect 
the virus is, and you can see clearly that the optimum 
concentration is 1 to 1.5 micrograms per ml.
    Next slide, please.
    This slide shows the results of in-cell PCR by two 
different technologies. One is in-cell solution phase PCR, the 
other is in-cell TaqMan PCR, which produces a green signal in 
the right-hand panels, top and bottom. Again it demonstrates 
that we can clearly identify measles virus in these transvected 
cells.
    Next slide, please.
    This is a patient with subacute sclerosing panencephalitis. 
Measles virus is the cause of this condition. So of course, if 
we are to reliably detect measles virus in biopsies of the 
children that Dr. Wakefield provided to us, we should of course 
be able to identify measles virus in brain biopsies from 
patients with SSPE.
    The left panel and the middle panel show measles virus 
presence in these biopsies, and the right-hand panel is the 
negative control.
    Next slide, please.
    This is a case of an autistic child No. 1. You can see the 
top left-hand panel is a microscopic appearance of what the gut 
looks like--and this is not normal gut epithelium from a child; 
it is heavily inflamed. The bottom left-hand panel show a 
spidery, black deposit, outer width of the cells that are in 
green. This is actually measles virus RNA. The top right-hand 
panel again in a different field shows a heavier deposit of 
black, which again is measles virus, and again, I need to point 
out to you that this is outer width of the cells that are 
surrounding it.
    Measles virus was located in the tonsils, in the lymphoid 
hyperplastic areas that Dr. Wakefield described on endoscopy. 
And the negative control is absolutely clean.
    Next slide, please.
    This is another case, a second autistic child, again 
showing a very similar findings--a black deposit, which is 
measles virus, outside of inflammatory cells, associating the 
fibrillary matrix, and the negative controls here for mumps are 
absolutely clean.
    Next slide, please.
    I think this slide is extremely important. If you look at 
the left-hand panel, this is measles virus for the nucleocapsid 
gene. It is a black signal. It again is the outer width of the 
cells, but it has a spidery, cobwebby morphology. There are 
little processes and tentacles coming out of this region. If 
you look at the top right-hand panel, the follicular dendritic 
cell has processes, dendrites, which form the cell matrix, 
which is very, very similar to what we see on the left-hand 
panel. And the immunocytic chemical staining analysis which Dr. 
Wakefield alluded to gives exactly the same results.
    Next slide, please.
    By solution phase PCR, by what we call fairly standard 
laboratory protocols, we can detect the measles virus in gut 
biopsies from these children, and the negative controls are 
appropriately negative.
    Next slide, please.
    Even in a paraffin-embedded tissue section that has 
probably been sitting around in wax for 4 to 5 years, we can 
detect measles virus. That is an astounding finding in view of 
the fact that wax and fixation by itself breaks down RNA. This 
graph shows in real time, we can look at the accumulation of 
the PCR product that we are making, confirming that measles 
virus is actually present in this biopsy.
    Next slide.
    And of course, we can sequence it, and we can say that this 
is measles virus RNA present in the biopsies of these children.
    To do this properly, you need to do it in a forward and 
negative strand. I started off by saying that measles virus is 
an RNA virus. When we make copies of the RNA virus, we make 
copies in two-strand forms. So if we are to sequence it, we 
should sequence in a forward and reverse strand.
    Looking at that electrophoretogram, the sequences in both 
directions are exactly the same.
    Next slide, please.
    In summary, then, in terms of the association that Andrew 
Wakefield alluded to, I can confirm that his hypothesis is 
correct--24 out of 25 children--that is 96 percent of the 
children's biopsies that he sent to my laboratory, blinded--
children with autistic enterocolitis harbor measles virus 
genomes.
    Three out of four patients with Crohn's disease--these are 
children with Crohn's disease--and one out of two children with 
ulcerative colitis also contain measles virus. That is an 
interesting biological fact.
    Finally, 1 of 15, 6.6 percent, of control children harbored 
measles virus genome. I think it does not take greater 
statistical analysis to work out that there is a significant 
difference between 24 out of 25 and 1 out of 15.
    Next slide.
    Solution phase RT-PCR, which is standard laboratory-based 
technology, was positive in all children with autistic 
enterocolitis for different regions of the measles virus 
genome. That is extremely important. And we can sequence 
measles virus isolates from these children.
    Final slide, please.
    However, the infection that is present in these children is 
at extremely low copy, at about 5 to 30 transcripts per 
approximately 2,000 cells.
    Now, again, I want to add some technical overlay on this. 
The way that we quantify RNA in our laboratory is by a method 
called copy RNA. Again, we are one of the few laboratories 
worldwide that would do this as the most accurate way of 
actually measuring RNA. Indeed, industry now is accepting this 
as a standard way of quantifying RNA in cells of tissue 
sections.
    Finally, the presence of measles virus was identified by in 
situ hybridization, by solution phase PCR, by TaqMan PCR, by 
in-cell PCR, by sequencing. This really, in terms of 
technology, is as good as it gets right now.
    I hope that I have given you evidence here which is 
compelling in relation to the presence of measles virus in 
children with autistic enterocolitis.
    Thank you for your time and attention.
    Mr. Burton. Thank you, Professor, and when we get to the 
question-and-answer phase, I am sure that we will try to ask 
questions in layman's terms and try to get some answers so that 
we can understand everything that both you and Dr. Wakefield 
said--but I think we got the gist of it.
    Dr. Singh.
    [The prepared statement of Dr. O'Leary follows:]
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    Mr. Singh. Thank you very much, Mr. Chairman.
    I did not realize that I could have shown a couple of 
slides as well to make the point much more in layman's 
language, but I will try to explain the results of the research 
that I am involved in.
    It has been nearly 25 years that I have been involved in 
so-called childhood diseases, from the immunology side as well 
as the pediatric neurology side. I was working at Children's 
Hospital in Vancouver, Canada, which is where I began my career 
in childhood diseases, and early on, I saw a few examples of 
autism mentioned in congenital rubella syndrome. It was a 
fascinating observation, because at that time, I was very 
excited about the research on virus infections and nervous 
system disorders. That really led me to kind of work back and 
forth between nervous system disorders and virus infections and 
immunology.
    So the whole thing here is that we need to consider 
combination of these disciplines that we talk about. We are not 
going to be able to answer any questions as far as I am 
concerned about nervous system diseases simply by studying 
psychology or simply by looking at the epidemiology data. We 
need to come together as a team to focus histories of nervous 
system, immune system, and whatever else comes into the 
picture. That is one major focus of attention that at least I 
am taking for my future research.
    On autism as an immune disorder, I think I am probably one 
of the earlier investigators who started working on the 
immunity and autism connection. Followed by that was my theory 
that autoimmunity is a very important process in autism. That 
is partly because I was studying autoimmunity in nervous system 
disorders like multiple sclerosis and Alzheimer's disease. 
Quite frankly, some of my earlier work in Alzheimer's disease 
has opened the way, and today, people are actually using 
immunology as a platform to design treatment for Alzheimer's 
disease.
    It was funny to see on the news last night that some doctor 
has a new approach; he says he is going to use immunology as a 
means of activating the nervous system in order to correct the 
Alzheimer's problem. That is a fascinating stuff, at least to 
me.
    So I started to pay more and more attention to autism, and 
the results that I am going to share with you are actually 
quite unique to autism. They are part of the nervous system, 
but they are being analyzed by the immune system research.
    I know there are people, especially who are funded by NIH 
or by CDC, who continue to make no mention at all of this so-
called immunology research or autoimmunity research in autism. 
I have been invited by the NIH panel; I have made two trips to 
NIH panels. I made a visit to the Institute of Medicine and the 
National Academy of Sciences about 1\1/2\ or 2 years ago. And 
if you hear those people who have been funded by these 
agencies, when they go out and present, they do not even 
mention anything about autoimmunity in autism. NIH people 
prepared a document of that meeting. It was designed for 
updating the screening and diagnostic criteria. If you read 
that document, there is virtually no mention of this sort of 
research. To me, this is simply mind-boggling.
    Is it because people out there in the scientific community 
do not want to buy the argument, or are they just being naive 
about what is already coming out in the way of solid, decent, 
experimentally proven research?
    Now, having given that background, let me show you some of 
the results. First of all, I started looking at autism as an 
autoimmune disorder, as I mentioned. And what we have found is 
over the last 5 or 6 years of research--and I think now, the 
number of cases I have studied is approaching about 400 cases--
very early on, I wanted to study the myelination problem in the 
brain. You will ask what is myelination. It is one of the most 
critical events in the nervous system development. So when a 
child is actually growing, this myelination process is very 
important. It is really more or less like a mother will feed a 
child and perhaps nurse in such a way that this process has to 
be nurtured very, very carefully.
    Having said that, what we are finding is auto-antibodies. 
Auto-antibodies are the hallmark of the autoimmune process. If 
you have an autoimmune process, you are going to have auto-
antibodies, but if you have those antibodies against an organ 
which is affected in a disease--in autism, what would that be--
that would be the brain. So we are finding brain auto-
antibodies in autobodies.
    What I am trying to illustrate in this chart is that we had 
a number of normal children, normal adults, patients with other 
disorders, Down syndrome, and none of those seemed to show 
these auto-antibodies, but on a rare occasion, 1 or 2 percent 
positive in the normal or control population.
    Here, we have a scientific observation which anybody can go 
out there and repeat. I do not think I need to use any 
difficult thing to illustrate that point. It is a consistently 
reproducible result, and it is happening now in children all 
over the world. I am getting specimens from overseas as well, 
not just the nationwide specimens alone. So this is a very 
important thing.
    Furthermore, I find that particular protein marker is 
selective, because I have now studied two additional markers of 
the same structure in the brain, and I do not find these auto-
antibodies in autism.
    Let me move on to the next issue. What happens is, assuming 
there is an autoimmune process, most autoimmune diseases are 
triggered by virus infections. So I started to think about 
looking at viruses. I was not thinking of the vaccine issue at 
all. I was thinking of virus infection. And, quite 
surprisingly, when I started to do antibody measurements to 
viruses which are out there or temporarily associated, what I 
found was that the measles virus stands out as statistically 
significant in terms of its antibodies, significantly much 
higher in autistic children. So these children have what is so-
called hyperimmune response to the measles virus--not other 
viruses. We studied rubella virus, HHV-6 virus, 
cytomegalovirus, and none of those three viruses showed this 
hyperimmune antibody response.
    Furthermore, the important thing is the measles antibodies 
which we have now measured by two different methods, and the 
result is the same--a statistically significant increase.
    The next thing I wanted to see was if anything correlated 
between these two parameters. Quite strongly, I found that 
brain auto-antibody-positive patients also had measles antibody 
levels which were very high. So the higher the antibody level 
to measles virus, the higher the chance of brain auto-antibody. 
It does not take too much intelligence to make some sense here 
now.
    Over the years, some of these families have been sending me 
written notes or telephone calls and so on, and every time I 
was going out to make my presentation, people would tell me 
about the vaccine connection with autism.
    Early on, I was not sure what was happening. So I tried to 
put together their own reports, and the report looks like this 
in the pie chart. Nearly 53 percent of the families reported 
that their child got autism because of MMR. The remaining 30 
percent said it was because of the DPT shot. And about 15 
percent--this was a critical category for two reasons--about 7 
percent said they were not sure whether it was measles or DPT, 
but the remaining 7 percent had no history of vaccination 
connection, or at least they did not make the connection. I 
wonder if that 7 or 8 percent category is where Dr. Dankner's 
child might fit in.
    The last point I want to make is that of a very recent 
research finding of my own, not yet published, but something 
quite important. About which I showed a slide in my 
presentation in a meeting last year which was held in Orlando, 
FL. This is an observation of antibodies to measles, mumps, 
rubella (MMR) itself. I decided to start with measles, mumps, 
rubella, because that is the largest population which was 
reported to me as being affected by the measles vaccine.
    We took the vaccine preparation itself, and we decided to 
examine antibodies in these children. Normal children do not 
show any antibody to a protein that I will point out in a 
second, but in children with autism, nearly 65 percent of them 
showed that antibody.
    Actually, I can illustrate that point a little more if we 
just imagine that I am a molecule, or a preparation of measles, 
mumps, rubella. This protein, this antibody that I am detecting 
will be something like detecting this coat pin. In other words, 
antibodies to this protein which is present in the measles, 
mumps, rubella vaccine preparation were found in autistic 
children, but not in the normal children. I think this is a 
very, very important laboratory-based research evidence. If 
anybody wants to make a criticism of that, of course, they are 
at liberty to do so. However, I find this is a scientifically 
very, very important observation, telling us that perhaps there 
is a good connection, there is something happening with this 
measles, mumps, rubella vaccine in these children, something is 
unusual.
    So basically, after having illustrated some of these 
points, I want to make a final comment. That is, if you really 
look at the literature reported on the vaccine adverse 
reactions, I do not think you will need a crystal ball to see 
that vaccines have adverse reactions. The literature is full of 
those reports. What is not there or is it has never been 
reported, or at least, the officials from the CDC continue not 
to mention anything about it. What they mention is that 
vaccines are good. Every week, you read about it in the 
newspaper, and you hear about it on the television. And I do 
not dispute that information because I know vaccines are very, 
very important. My concern as a researcher now, more so than 
ever before, is that we must pay attention to the safety of 
these vaccines. It is missing; it has not been disclosed 
publicly, and I do not think it exists in the literature, and 
therefore, I urge the Government Reform Committee to look into 
particular new policies concerning the vaccine safety issue.
    Thank you very much.
    Mr. Burton. Thank you, Dr. Singh.
    Dr. Boyle.
    [The prepared statement of Mr. Singh follows:]
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    Ms. Boyle. Good afternoon, Mr. Chairman and members of the 
committee. I am Dr. Coleen Boyle, Chief of the Developmental 
Disabilities Branch at the Centers for Disease Control and 
Prevention. I am presenting the agency's testimony, and I am 
accompanied by Dr. Ben Schwartz, who is the Acting Director of 
the Epidemiology and Surveillance Division at the National 
Immunization Program at CDC.
    I am pleased to discuss our work at CDC to prevent 
developmental disabilities including autism. I want to begin by 
assuring the parents that we have heard from today that CDC is 
concerned about autism, and that we are working hard to find 
the causes of autism and other developmental disabilities so 
that all children will have the opportunity to have a healthy 
and productive future.
    Autism is a serious developmental disability which can have 
profound impact on children and their families. It is 
characterized by qualitative impairments in social interactions 
and communication and a pattern of restrictive, repetitive, and 
stereotypic behaviors, interests, and activities. Autism may 
require long-term special education and care at a cost of more 
than $30,000 per year. Costs for residential care can be 
$80,000 to $100,000 per year.
    CDC's role in preventing developmental disabilities 
including autism is to track the disease rates in the 
population and to identify causes of this condition. CDC can 
then establish prevention programs and then evaluate how well 
these programs work.
    We do not know if autism rates are going up. Early studies 
found autism rates in the range of 4 to 6 per 10,000 children, 
using a narrow set of criteria. More recent studies have 
reported rates averaging 12 per 10,000 children, but these 
studies have used different criteria than the earlier studies.
    CDC is not certain how much of the reported increase is due 
to changes in the definition of autism or an improved 
recognition of this condition over time. We also do not know if 
other factors have contributed to the larger numbers of 
children seeking treatment.
    CDC is currently developing ways to better measure autism. 
In 1998, we added autism to our Metropolitan Atlanta 
Development Disabilities Surveillance Program. This program, 
which also monitors other serious developmental disabilities 
such as mental retardation and cerebral palsy among school-age 
children in Atlanta, is the only community-wide study in the 
United States. CDC has just funded Marshall University in West 
Virginia to start tracking autism in six countries in that 
State.
    At this point, I want to briefly describe our activities in 
Brick Township, NJ and in investigating the alleged association 
between autism and the MMR vaccination.
    In early 1998, the CDC and the Agency for Toxic Substances 
and Disease Registry [ATSDR], were contacted by the New Jersey 
Health Department, Senator Robert Torricelli, and U.S. 
Representative Christopher Smith, requesting the CDC 
investigate autism rates in Brick Township. They were concerned 
that the number of children with autism was too high.
    In response, CDC conducted a study of children with autism 
living in Brick Township during 1998. ATSDR investigated 
sources of environmental pollution and exposure routes in Brick 
Township. All the data have been collected, and the results are 
currently undergoing scientific review. Once this review is 
completed, we will provide the report first to the parents of 
the affected children, the community, and then the local and 
State health departments. We would be pleased to brief 
interested Members or their staffs on the results of this work 
at the time we make them available to the community.
    As the committee is aware, a theory links the MMR vaccine 
and autism, which has generated public interest and some 
controversy. CDC believes that the current scientific evidence 
does not support the hypothesis that MMR or any combination of 
vaccines cause the development of autism. Initial case series 
reports have not been substantiated by more focused reviews or 
by more in-depth followup research.
    It should be pointed out that factors known to be 
associated with autism include genetic factors and events that 
occur before birth.
    CDC recognizes how important it is to identify the causes 
of autism as well as to ensure the safety of vaccines. CDC is 
currently undertaking three studies related to autism or about 
hypotheses related to vaccines and autism.
    First, CDC is using its Autism Surveillance Program in 
Atlanta to examine the possibility of a link between the MMR 
vaccine and autism.
    Second, we are working with the National Institutes of 
Health to conduct a study that will evaluate whether 
vaccination is linked with developmental regression which 
occurs in some children with autism.
    Third, CDC is using the Vaccine Safety Datalink, in 
collaboration with several HMOs, to study inflammatory bowel 
disease and the MMR vaccination.
    Through these studies, CDC is working to assure the safety 
of the vaccination program and to identify preventable causes 
of autism.
    Mr. Chairman, in the past 4 years, public health has made 
significant advances in preventing developmental disabilities. 
Prevention of congenital syphilis and congenital rubella 
syndrome have spared lives and prevented disability for 
thousands of children. Newborn screening programs have 
prevented lifelong mental retardation in children with 
hyperthyroidism and sickle cell disease.
    However, given these strides, we still do not know what 
causes many developmental disabilities, including autism. While 
additional scientific research is being completed, it is 
important to also consider the broader context of public 
health, including the vaccination program, which is one of the 
most successful public health achievements of the 20th century.
    Given the weight of the scientific data and the known 
seriousness and ongoing risk of vaccine-preventable diseases, 
in CDC's judgment, the best public policy is to continue 
vaccination unchanged while aggressively working to try to 
identify causes of developmental disabilities.
    CDC agrees with the committee and the parents who have 
testified today that autism has a significant and profound 
adverse impact on the lives of children and families and 
communities where it occurs. We must track this disorder, we 
must identify the preventable causes, and we must institute 
effective prevention programs.
    It is my hope that our efforts, combined with those of the 
NIH and the academic community, will lead to a way to prevent 
developmental disabilities of autism, enabling those children 
to live full and productive lives.
    Thank you, Mr. Chairman and members of the committee.
    Mr. Burton. Thank you, Dr. Boyle.
    Dr. Offit.
    [The prepared statement of Ms. Boyle follows:]
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    Dr. Offit. First, I would like to recognize the courage of 
the parents who have testified her today, as well as the two 
grandparents on the committee, including you, Mr. Chairman. As 
I share my testimony, I also deeply share their feelings and 
concerns.
    My name is Paul Offit. I am pediatrician, and I am also the 
chief of infectious diseases and the Henle professor of 
immunologic and infectious diseases at the Children's Hospital 
of Philadelphia and the University of Pennsylvania School of 
Medicine. In addition, I am a member of the Advisory Committee 
on Immunization Practices to the CDC. I have 20 years of 
experience in the areas of virology and immunology.
    My role in these proceedings is to explore the theories 
that have arisen due to concerns by the public that autism 
might be caused by the combination of measles, mumps, and 
rubella vaccines known as MMR.
    No evidence exists which proves this association. However, 
three theories have been used to explain it. In the time that I 
have been given, I would like to explain why I think that these 
theories are not valid.
    The first theory is that children who get the measles 
vaccine make an immune response not only to the vaccine, but 
also to their own nervous system. This kind of reaction is 
called autoimmunity. To understand why this theory is invalid, 
we must first understand differences between natural measles 
infection and measles vaccination.
    During natural measles infection, the measles virus 
reproduces itself many times in the body and causes disease. In 
contrast, following measles vaccination, the vaccine virus 
reproduces itself much less and does not cause disease. Because 
more measles proteins are made during natural infection than 
after immunization, the immune response to natural infection is 
greater than the immune response to immunization. If the immune 
response is greater after natural infection, then the 
autoimmune response would also be greater. If this were the 
case, then autoimmunity should occur more frequently after 
natural infection than after vaccination. Or, said another way, 
if measles virus caused autism, then measles vaccination would 
lower, not raise, the incidence of autism.
    The second theory is that the child's immune system is 
simply overwhelmed by seeing three viruses in a vaccine at the 
same time. Some have gone so far as to suggest that it may be 
of benefit to divide the MMR vaccine into three separate 
vaccines. The rationale behind this theory is that children do 
not normally encounter such an assault on their immune system.
    From the birth canal and beyond, infants are confronted by 
a host of different challenges to their immune system. Their 
intestines encounter foreign proteins in milk and formula. 
Their lungs encounter bacteria inhaled on the surface of dust 
in the air. And literally thousands of different bacteria 
immediately start to live on the skin as well as on the lining 
of the nose, throat, and intestines.
    Here is how infants deal with this immediate confrontation 
to their immune system. Babies have a tremendous capacity to 
respond to their environment from the minute they are born. The 
newborn has billions of immunologic cells which are capable of 
responding to millions of different microorganisms. By quickly 
making an immune response to bacteria that live on the surface 
of their intestines, babies keep these bacteria from invading 
their bloodstream and causing serious disease.
    Therefore, the combination of the three vaccines contained 
in MMR, or even the 10 vaccines given in the first 2 years of 
life, is literally a raindrop in the ocean of what infants 
successfully encounter in their environment every day.
    The third theory is that the MMR vaccine is given by an 
unnatural route. The rationale behind this theory is that 
children do not normally encounter viruses or bacteria under 
their skin or in their muscles. But infants and children 
frequently encounter viruses and bacteria in many places 
throughout the body. Our species survives because from the 
minute we are born, we are capable of meeting challenges at all 
sites.
    To review, here are the medical facts. First, if autism is 
a consequence of autoimmunity, the incidence of autism would 
have decreased, not increased, after vaccination.
    Second, children from birth are confronted with and manage 
an enormous array of different challenges to their immune 
system at the same time.
    Third, challenges to their immune system occur by a variety 
of routes.
    The parents we have heard testify here today are asking a 
scientific question: Does the MMR vaccine cause autism? 
Questions of science are best answered by scientific studies, 
and the answer to this question is already available. Dr. Brent 
Taylor and his coworkers in London have conducted a large, 
meticulously designed, well-controlled study that disproves an 
association between MMR vaccine and autism. I believe other 
studies will confirm Dr. Taylor's results, because it is 
important to have confirmatory studies.
    What is really at stake here? In the early 1990's, our 
immunization rates against measles dropped only about 10 
percent. Measles outbreaks swept across the country. About 
11,000 people were hospitalized, and 123 died from measles--
died from a disease which is easily and safely prevented by a 
vaccine.
    My concern, Mr. Chairman, is that parents listening to or 
reading about this hearing might incorrectly conclude that 
vaccines cause autism. This is not the case. Vaccines are 
extremely safe and highly effective. I encourage this committee 
to make that fact clear to every parent in America.
    If, as a result of reading about this hearing, some parents 
choose to withhold or delay vaccines for their children, their 
tragedy could be profound. If many parents choose to withhold 
vaccines, the tragedy all across America could be devastating.
    Let us proceed cautiously, carefully, and scientifically.
    Thank you.
    Mr. Burton. Thank you.
    Dr. Taylor.
    [The prepared statement of Dr. Offit follows:]
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    Dr. Taylor. Hello. I am Brent Taylor. I am the professor of 
community and child health at the Royal Free and University 
College School of Medicine and the head of the Department of 
Pediatrics and Child Health on the Royal Free campus of 
University College London.
    I am honored to have the opportunity to testify today. I am 
here as a clinical scientist, but I am also a practicing 
pediatrician. My clinical work involves children with 
disabilities including autism.
    I know how desperate families can be to understand the 
cause of their child's often devastating condition. I also know 
that if we are to avoid families being led astray by false 
hopes, advances in understanding and treatment must be based on 
high-quality and rigorous science.
    Mr. Wakefield and Professor O'Leary's testimony 
notwithstanding, the belief that MMR is the cause of autism is 
a false hope.
    I have four main points. We do not fully understand the 
reasons why autism has recently increased. We do know that 
there is no evidence that immunizations are involved.
    Second, there is no evidence that MMR vaccine causes 
autism. Third, there is no conspiracy to suppress information 
about the side effects of vaccines--completely the reverse. 
Fourth, because of poor science, uptake of MMR vaccine has 
fallen to dangerously low levels in the United Kingdom, putting 
children's lives at risk from a resurgence of the damaging and 
occasionally killing of preventable diseases, measles, mumps, 
and rubella. The same thing could happen in the United States 
of America.
    If I could have the first overhead, please.
    Here are some figures from the United Kingdom. You can see 
at the top, in the black closed circles, MMR uptake, which has 
fallen from about 90 percent in 1995 to 75 percent in April 
1999. There is almost an exact parallel fall--shown in the open 
circles--in mothers' confidence in the safety of MMR vaccine.
    Could we have the next overhead on top of this one, please?
    The reason for this loss of confidence relates mainly to 
two papers produced by Mr. Wakefield and colleagues. The first, 
which incorrectly related measles vaccine to Crohn's disease, 
one form of inflammatory bowel disease, has subsequently been 
completely undermined. There is no evidence that measles or 
measles vaccine play any part in inflammatory bowel disease.
    The second arrow shows the timing of a paper produced by 
Mr. Wakefield and colleagues describing a small group of 
inadequately described children with a range of autism-related 
disorders.
    Following each of these papers, there was a major effect on 
mothers' confidence and a resultant further decline in MMR 
uptake.
    I will now discuss the results of an epidemiological study 
I led to test Mr. Wakefield's hypothesis that MMR causes 
autism. My two senior colleagues, Dr. Elizabeth Miller and Dr. 
Patty Farrington, have submitted testimony to this committee 
with details of our methods and the background of our study.
    We identified all known cases of autism--498 in total--
living a defined area of North London and compared details of 
the onset and recognition of their condition with independently 
collected data on exactly when they received MMR and other 
measles-containing vaccines. The study involved a large amount 
of work, and we analyzed the data in considerable depth. There 
are lots of results which have been published in the Lancet.
    In summary, all of our analyses were negative. We concluded 
that MMR vaccine is not causally related to autism. In 
particular, we looked at the clustering after MMR of regression 
where it occurred, the timing of parents' concern about the 
child's development, and the age at diagnosis. There were no 
significant relationships.
    Our results are supported by other studies from Sweden, 
from Finland, and from France.
    Our particular interest in this hearing is the rise with 
time we identified from the late 1970's to 1992.
    Could we have the next overhead, please?
    Mr. Wakefield has compared our results with those reported 
in California. This is the overhead. It is important to 
remember that the authors of the California report clearly 
stated that theirs was not incidence data.
    The overhead, which is downloaded from the Lancet Web page, 
is of rather poor quality, and so is Mr. Wakefield's content. 
He has fiddled with the data regarding the dates of the 
introduction of autism, and to demonstrate other problems he 
has with time relationships, it is worthwhile just looking at 
the bottom line, where it goes from 1987 to 1960 to 1990. What 
is actually going on?
    I have included two additional arrows, the red arrows, 
which perhaps more accurately identifies the acceleration in 
cases in the rates at which autism is increasing. These, one 
can see, occurred at least 2 years before autism was introduced 
into the United Kingdom and at least 2 years after in 
California--hardly a convincing causal relationship.
    There is another problem for the MMR theory. Could we have 
the next overhead, please?
    Here is our data from our study up until 1992, which is 
what we published. The rise in autism can be seen there as 
clearly occurring long before MMR was introduced, and I must 
say, contrary to what Mr. Wakefield and some of the groups he 
is associated with say, that we included all cases in our 
analysis, including those involved in the MMR Catch-Up 
Campaign.
    After 1992, the numbers fell. We did not include these data 
in our analysis because we felt that there might be too many 
missing cases not yet diagnosed, and by leaving the left-hand 
side, it really gave the hypothesis that MMR causes autism the 
best chance of being confirmed.
    The parallel line in red is data from two of the larger 
districts, and this is important, because we have preliminary 
data as part of the further study on the same population to see 
what has happened. Is autism still going up, or is it 
flattening out?
    What our early results in these two districts show--if we 
could have the final overhead--is that rates are going down. 
There is an overall increase of numbers, reflecting continuing 
better recognition of autism, and immigration. The fall is seen 
in both studies, suggesting it is a real fall. Cases appear in 
this population to have peaked in about 1992, for reasons which 
are quite unclear.
    This finding alone must exclude MMR as a cause of autism. 
MMR had a rapid uptake in our population from 1988; then, rates 
plateaued, certainly until 1995, while autism rates were rising 
and then falling.
    We need more research on autism and its treatment, but Mr. 
Chairman and members of the committee, present evidence does 
not support a causal relationship between MMR vaccine and 
autism. As a result of adverse publicity on this topic, many 
clients in the UK are now at risk from the dangerous diseases 
of measles, mumps, and rubella. I urge this committee to 
strongly support the continued MMR program to avoid putting 
America children's lives at risk.
    As a result of my work and clear study of the evidence on 
this topic, I believe I can say with confidence that MMR 
vaccine is not a cause of autism.
    [The prepared statement of Dr. Taylor follows:]
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    Mr. Burton. I want to thank the panel. We will now go to 
our questions.
    Dr. Offit, you talk about collaboration, I guess, with the 
Merck Pharmaceutical Co.?
    Dr. Offit. Yes. As I disclosed in my written report, I have 
been in collaboration with Merck and Company on the development 
of a rotavirus vaccine since 1992.
    Mr. Burton. Do you do any traveling around, speaking on 
behalf of Merck or Merck products?
    Dr. Offit. I travel and speak about vaccines, and those 
talks are supported by unrestricted educational grants from 
either pharmaceutical companies or from universities.
    Mr. Burton. So they pay for your expenses and that sort of 
thing?
    Dr. Offit. They have an interest in educating physicians 
about vaccines, and it is good that they do, because physicians 
need to be educated about vaccines.
    Mr. Burton. I understand. And they produce the MMR vaccine, 
don't they?
    Dr. Offit. Yes, they do, yes.
    Mr. Burton. Thank you.
    Dr. Taylor, in your Lancet paper, you omitted to mention 
the Catch-Up Campaign. That is the vaccination of children over 
1 year of age when the vaccination was introduced. Yet you 
appear to have included these Catch-Up children in your 
analysis of the step-up hypothesis. So you consider that to be 
methodologically--do you think that is a correct analysis?
    Dr. Taylor. Basically, that statement is not true, Mr. 
Chairman. We did include the children involved in the Catch-Up 
Campaign in our analysis, as is clearly stated. To suggest 
otherwise--and I suspect the suggestion comes from Mr. 
Wakefield--is malicious.
    Mr. Burton. Well, was it included--was it not omitted in 
the original paper that you submitted?
    Dr. Taylor. No. All cases were included who received MMR 
vaccine. All cases--we will submit additional analysis with all 
cases who received any measles-containing vaccine----
    Mr. Burton. Didn't some of those 36 children receive the 
MMR vaccine after the----
    Dr. Taylor. I think what you are referring to is the reply 
which we put to Mr. Wakefield's criticism of our paper in the 
Lancet. I have to say that his is the only criticism of our 
paper which we have received on a scientific basis. All other 
reports have been constructive and supportive.
    Mr. Burton. Well----
    Dr. Taylor. What we looked for there were the children who 
had received MMR vaccine, which we had included in our 
analysis. There were 36 such children, and in 29 of them, there 
was evidence regarding when the parents became concerned about 
their child's development. In all cases, this was before they 
received the MMR vaccine.
    Mr. Burton. We have an epidemiologist in the audience, 
and--where is he?
    Would you mind coming up? I would like to have you sworn in 
real quickly.
    Dr. Spitzer. Yes.
    [Witness sworn.]
    Mr. Burton. Thank you.
    Can you explain the importance of properly counting these 
children born before 1988 who were given the Catch-Up vaccines?

   STATEMENT OF DR. WALTER O. SPITZER, PROFESSOR EMERITUS OF 
 EPIDEMIOLOGY, MCGILL UNIVERSITY, AND MEMBER, NATIONAL ACADEMY 
      OF SCIENCE OF THE UNITED STATES, CORPUS CHRISTI, TX

    Dr. Spitzer. Well, as implied by Professor----
    Mr. Waxman. Point of order, Mr. Chairman. Point of order, 
if you will suspend your answer to that question. I want to 
make a point of order.
    Mr. Burton. The gentleman will state his point of order.
    Mr. Waxman. The rules of this committee require that 
``Witnesses appearing before the committee shall, so far as 
practicable, submit written statements at least 24 hours before 
their appearance, and, when appearing in a nongovernmental 
capacity, provide a curriculum vitae and a listing of any 
Federal Government grants and contracts received in the 
previous fiscal year. Identification of witnesses are to be 
provided to members of the committee.''
    Suddenly, we have a witness being called forward, and Rule 
2 says ``Every member of the committee or the appropriate 
subcommittee, unless prevented by unusual circumstances, shall 
be provided with a memorandum at least 3 calendar days before 
each meeting or hearing explaining 1) the purpose of the 
meeting or the hearing, 2) the names, titles, background and 
reason for appearance of any witness. The ranking minority 
member shall be responsible for providing the same information 
on witnesses whom the minority requests.''
    Suddenly, we have a witness being called forward. We have 
all of these people testifying, and we have now a witness 
coming up--I do not know who he is. It just seems to me that 
this is in violation of the rules.
    Mr. Burton. I think as you were reading there, where there 
are ``unusual circumstances''--and I believe you can go back 
and read that again--or whenever ``practicable'' was another 
term that was used in there--so the chair--excuse me, let us 
suspend for one moment. [Pause.]
    Mr. Waxman. Mr. Chairman, if I might be heard----
    Mr. Burton. No----
    Mr. Waxman [continuing]. And I am going to withdraw my 
point of order--but I do want to say that there are procedures 
for the conduct of hearings which provide for opportunities for 
all points of view to be expressed. And for a witness to be 
brought out of the audience because the witnesses before you 
did not give you testimony that fit with your preconceived 
theory seems to me to turn a congressional hearing more into a 
circus than a genuine fact-finding opportunity.
    But I will not object if you want to call this witness. I 
do want to also point out that we have rules on the time 
allocated to members, and I would insist that that time be 
observed or that all members be given the same open-endedness 
that I see about to come in your questioning, because the clock 
that usually keeps time for our questioning has been 
deliberately stopped.
    I will not object, but I do think it is inconsistent with 
the rules of this committee to bring witnesses out of the 
audience when you have a panel here that just testified, with 
whom we ought to pursue our questions.
    Mr. Burton. The parliamentarian has just informed me that 
where there are extenuating circumstances, the chair has the 
ability to bring a witness forward--and this is not the first 
time this has happened.
    [Applause.]
    Mr. Burton. That is the first thing. The second thing is 
that this is one of the most important hearings I think we have 
had, because we are talking about an epidemic of autism that is 
taking place in this country, and if there is information that 
is being given to the committee that is going to be in the 
Congressional Record that is not accurate, it needs to be 
corrected as quickly as possible so the American people and 
people from around the world who may want to look at the record 
of this committee have the facts.
    Now, if we have an epidemiologist here who has expertise 
about a report and can cite that information about this report 
where there might be an error, then we ought to correct it 
right now, instead of waiting until a report is filed, goes out 
to the American people, and then try to correct it where there 
might be a misunderstanding. So----
    Mr. Waxman. Well, we do have an epidemiologist on this 
panel, and perhaps you ought to question her, or this other 
witness should have been asked to testify. No one would have 
objected to having anybody who had anything pertinent to say to 
us to have an opportunity to present what they have to say.
    Mr. Chairman, let us proceed, and let us keep the rules on 
time, or acknowledge the open-endedness of questions, because 
we will have a lot of questions as well.
    Mr. Burton. Dr. Spitzer.
    Dr. Spitzer. Very briefly, Congressman Waxman, your points 
are well-taken, and I respect them. I will say now to Professor 
Taylor that those additional cases in the Catch-Up Campaign may 
well have been included in the paper but were not clearly 
segregated or identified or enabled peers to evaluate the 
possible impact of including them or not, so the findings may 
have been misleading until we reanalyze them taking that into 
account.
    Moreover, the use of the case series strategy of analysis 
is unconventional, not accepted by mainstream scientists, and 
leaves the paper at best as a hypothesis-generating study and 
not something with which he or anyone can categorically say 
this proves that there is no relationship. It just shows and 
emphasizes what he said himself, that we need to study it 
further.
    So we have a compelling reason to have a blue panel, an 
international panel, to go back to that data base, look at the 
raw data, and be able to come up with a second assessment that 
is verifiable by the scientific community and the relevant 
community.
    Thank you, Mr. Waxman, Mr. Chairman.
    Mr. Burton. Thank you very much.
    Mr. Tierney. Point of order, Mr. Chairman.
    Dr. Taylor. Mr. chairman, can I comment on that?
    Mr. Burton. Stop the clock.
    The gentleman will state his point of order.
    Mr. Tierney. Is Mr. Taylor going to be given an opportunity 
to respond at this point in time?
    Dr. Taylor. May I comment?
    Mr. Tierney. I think it might be helpful to those of us who 
are sort of surprised by this new witness. I would like to hear 
what Mr. Taylor has to say in response to that. I think it 
would be educational.
    Mr. Burton. I have no objection to him responding, but I 
have some more questions of Dr. Wakefield, so----
    Mr. Tierney. Well, Mr. Chairman, my point of order is can 
we have them nearer in time to each other so we can get the 
full benefit of it, rather than go back and forth.
    Mr. Burton. I will yield to the gentleman next. He can have 
the time next, or Mr. Waxman can, and he can yield to Dr. 
Taylor.
    Dr. Wakefield, would you come back up, please? Dr. 
Wakefield, would you clarify the difference of opinion that you 
have from your colleague?
    Dr. Wakefield. My anxiety, Mr. Chairman, is that if you 
test a step-up hypothesis--that is, those children who should 
be the first to receive the vaccine at the age of 1 year, born 
in 1987, because the vaccine was introduced in the UK in 1988, 
and therefore they would have been 1 year old, then the take-
off, if there were a relationship between MMR and the vaccine, 
should have occurred at that point.
    The paper illustrated the point that the take-off occurred 
before those born in 1985 and 1986. What took place when the 
MMR was introduced was the Catch-Up Campaign, where all 
children of 1 to 4 years of age were targeted. It was an 
aggressive campaign--I know that, because one of the authors on 
the paper that we published in the Lancet was in charge of that 
campaign for Hackmey in Northeast London. If you give the 
vaccine to children over the age of 2, then it will cause the 
take-off to occur before 1987, and that is exactly what 
occurred.
    Now, at the very least, those cases should have been 
mentioned, because the reviewers, in the absence of those data, 
cannot give a valid interpretation of the paper when they make 
a recommendation for it to be published or not, and they should 
have been excluded from the analysis so we could see how the 
graph looked without them, and that did not occur, and that is 
a major anxiety.
    Mr. Burton. Dr. Taylor, do you want to respond now?
    Dr. Taylor. It does seem slightly surprising that at one 
moment, we are accused of excluding them and therefore that 
upsets the results, and now we are accused of including them, 
and that upsets the results.
    I have to say the time relationships, the step-up part of 
our paper is the least important part of our findings. The 
direct findings, the time series analysis, is much more 
important, which is the direct evidence that the individual 
children did not develop symptoms of autism within various 
defined periods after they received the MMR vaccine.
    If I could just comment on Dr. Spitzer's comment, he 
describes our analysis as unorthodox. We used the highest 
standards of epidemiological and statistical analysis in our 
handling of this data, and this data has been reviewed by 
numerous experts, both prior to publication and since.
    Last week, our research was the basis of a detailed debate 
at the Royal Statistical Society, where there was no criticism 
of the statistical techniques that we used, and the conclusions 
of our paper were accepted by this very expert group.
    The testimony which you received from Dr. Elizabeth Miller, 
who is an epidemiologist, and Dr. Patty Farrington, who is an 
expert statistician, is tabled for the committee's 
consideration.
    Mr. Burton. Would you mind, since there is a strong 
difference of opinion between you and Dr. Wakefield, and I 
presume some others, providing the data for your study to the 
committee, the complete data?
    Dr. Taylor. I will have to take advice on that from both my 
colleagues and the others. I would be required to decide 
whether the committee is an appropriate body for this 
information, which was collected, as you know, by the Medicines 
Control Agency, which is a branch of the Department of Health 
in the UK. In principle, I have no problem, but in practice, I 
would need to check----
    Mr. Burton. Well, we would be very happy to write to the 
Department of Health in the UK and ask that you be able to 
release that information to the committee in total so that we 
could have somebody who is totally nonbiased, hopefully, on 
this issue to analyze it.
    Dr. Taylor. Yes. I think it would need to be done by more 
than a selected statistician. If it is to be reanalyzed, it 
should be reanalyzed by independent individuals--which, of 
course, is the problem with much of Mr. Wakefield's research, 
that it has never been independently verified. No one anywhere 
in the world has been able to reproduce any of his studies, and 
it seems possible, and it is only going to be a matter of time 
before this most recent information is also found to be 
inadequate.
    Mr. Burton. Well, my time has expired, but let me just say 
that I believe that Dr. Wakefield and Professor O'Leary and 
others would be willing to give us the documentation in the 
study that they did, and we would like to have yours as well so 
we can look at all of that.
    Mr. Waxman.
    Mr. Waxman. Mr. Chairman, because I believe autism is such 
a serious problem, I am troubled by this hearing. This hearing 
was called and structured to establish a point of view, and it 
is the point of view of the chairman. The chairman believes a 
particular point of view, and that is the connection between 
autism and vaccinations.
    You can look at it by the first panel, where we had five 
parents, all of whom believed the same thing that the chairman 
believed, and the way we just had the handling of the questions 
a minute ago.
    What also bothered me was when we asked that we have the 
American Medical Association or the American Public Health 
Association or the National Network for Immunization 
Information or the former Secretary of HHS, Dr. Louis 
Sullivan--real experts in addition to those we have before us--
we were told no, they cannot fit in.
    I think hearings like this have a real danger because if 
you sensationalize the idea that there is a connection between 
immunization and autism, immunization rates will drop. That is 
what happened in Great Britain after Dr. Wakefield published 
his first study. Immunizations dropped. Autism rates did not 
drop, but measles rates increased.
    I was impressed by the statement that we had a drop of just 
10 percent in measles immunizations in 1990, and then we had 
11,000 people hospitalized from measles. This can cause brain 
retardation and death. We know we can prevent that. Why should 
we then scare people about immunizations until we know the 
facts?
    I fear that what we have in this hearing is a 
sensationalization by the chairman in order to get all these 
cameras to report to the American people that there is this 
connection because he believes it, and many other people 
believe it, and therefore a lot of others who watch this will 
think, ``I will not immunize my children.''
    Dr. Wakefield came out with a report in England, and the 
first group that examined his claims was the Medical Research 
Council, which is the British equivalent of the NIH, and they 
found no evidence to indicate any link between the MMR vaccine 
and bowel disease and autism.
    After they did their work, the Chief Medical Officer of the 
United Kingdom issued a letter to doctors in 1998, stating, 
``Based on the previous material that I have seen and on the 
opinion of experts present at the Medical Research Council, I 
have concluded there is no link between measles, measles 
vaccine, or MMR immunization,'' etc.
    Then, the World Health Organization looked at his study, 
and they came up with the following statement: ``Given our 
view, the previous scientific claims made by Dr. Wakefield and 
colleagues lack scientific credibility, and his present study 
does not meet the requirements for establishing such a causal 
relationship.''
    I do not know whether that is true or not, but that is what 
the scientists in England said when they evaluated it, as did 
Dr. Taylor when he evaluated Dr. Wakefield's study.
    Now, Dr. Wakefield has testified he has some new 
information. Fine. Let us get the new information out there. 
Let us let the epidemiologists evaluate it. Let us let 
scientists explore where the truth may be. But to put this out 
in a congressional hearing and scare people from getting 
immunizations--we know that without immunizations, dreaded 
diseases will occur, deaths and mental retardation and 
disability will occur among our children, and we can prevent 
that.
    What we do not know, and we have a lot of information to 
the contrary, is that autism will result from that 
immunization.
    Dr. Taylor--well, let me ask Dr. Boyle. You are an 
epidemiologist. Suddenly, we had to pull out of the audience an 
epidemiologist. But you are an epidemiologist. What do you have 
to say about this debate that we are seeing back and forth? 
Have you evaluated any of this information that is now being 
presented as if it were fact?
    Ms. Boyle. I think that the scientific data currently does 
not show an association between the MMR vaccine and autism. We 
have heard from Dr. Taylor. We also know that there is a study 
in Sweden by Dr. Gilberg and associates, who have been 
monitoring--Sweden is actually the only country that has been 
monitoring the rate of autism over time--and they looked at 
pre-MMR immunizations and post-MMR immunizations and found no 
changes in the rates of autism.
    Mr. Waxman. Well, I cannot tell you what is true or not, 
but I do not think our chairman can tell you what is true or 
not either, and I feel that when we had the hearings on whether 
there were campaign abuses by Democrats, a lot of people's 
reputations were ruined, and I thought the hearings were 
unfair. But those were political. The consequences of an unfair 
hearing on autism connected to vaccinations can cause people to 
die, and I worry about that, and I think we should get the 
facts before we make the assertions and not make the assertions 
and then throw out the witnesses who tell us information that 
does not fit those allegations.
    I yield back the balance of my time.
    Mr. Burton. The gentleman's time has expired.
    Does the gentlelady from Florida wish to question the 
panel?
    Ms. Ros-Lehtinen. Thank you so much, Mr. Chairman, and I 
thank you for holding this hearing.
    Rather than asking questions, because I am needed for a 
caucus in my other subcommittee, I want to thank you, Mr. 
Chairman, for holding this important hearing and for 
highlighting the need for further research as we explore the 
possible causes, interventions, strategies, counseling and 
other services to help families who are living with autism. We 
need to keep in mind that a person with autism is indeed a 
person first and not a behavior.
    These posters, which I would like to have the audience and 
the panelists see, show constituents from my Congressional 
District, Bonnie and Willis Flick, two beautiful children in my 
district who are living with autism, and, indeed, the whole 
family lives with autism.
    Bonnie and Willis are fortunate to be able to afford 
treatment and therapy, but so many other families are not as 
fortunate.
    So I thank you for the opportunity to hear from researchers 
and from parents and people who cope daily with this disease, 
and I commend you for your initiative, Mr. Chairman, in seeking 
answers to help those individuals with autism and for the 
opportunity to learn from experts and researchers.
    I especially want to thank you for allowing Dr. Cathy 
Pratt, the director of the Indiana Resource Center for Autism 
to come today and share her expertise on what we as 
policymakers can do to help families deal with autism.
    Approximately 50 percent of Florida's children with autism 
reside in my community in south Florida, so I am delighted to 
have you take this leadership role, Mr. Chairman, and have your 
committee address this issue so that 1 day, we can find 
prevention and methods and a cure to help us all cope with this 
rising curse of autism.
    I thank you very much, Mr. Chairman.
    Mr. Burton. Will the gentlelady yield to me?
    Ms. Ros-Lehtinen. Yes, Mr. Chairman.
    Mr. Burton. Let me just ask Dr. Wakefield, because I want 
to conclude with this panel and move on--would you be willing 
to give us all of the information on your study so it can be 
reviewed?
    Dr. Wakefield. Certainly.
    Mr. Burton. You will?
    Dr. Wakefield. Yes.
    Mr. Burton. Thank you very much.
    Professor O'Leary, would you be willing to give us all the 
information on your study so that we can review it?
    Dr. O'Leary. Yes, sir; no problem.
    Mr. Burton. I cannot hear you.
    Dr. O'Leary. Yes, sir.
    Mr. Burton. OK.
    Dr. Singh, would you be willing to give us all the 
information on your study so we can review it thoroughly?
    Mr. Singh. Yes, absolutely, without any hesitation.
    Mr. Chairman, if there is a moment, if I may have a chance, 
I would like to raise some interesting points later on.
    Mr. Burton. Yes, but just 1 second.
    Mr. Singh. Yes. Thank you very much.
    Mr. Burton. Now, then, Dr. Taylor, will you give us all the 
information on your study so we can review it along with the 
others?
    Dr. Taylor. In principle, I have no problem, but I would 
need to discuss that with my employing authority, University 
College London, and with the Department of Health, who funded 
this study.
    Mr. Burton. Who funded your study, Dr. Wakefield?
    Dr. Wakefield. We did. We have a small charitable 
contribution, but----
    Mr. Burton. A charitable organization did; I see.
    Dr. Wakefield. We found it a little difficult to get 
funding----
    Mr. Burton. And yours was done by the Government?
    Dr. Taylor. It was funded by the Medicine Control Agency, 
which is the body charged with responsibility for the safety of 
vaccines and other treatments.
    Mr. Burton. Well, I would be happy to work with the ranking 
Democrat, Mr. Waxman, to get an independent group of doctors/
scientists that we mutually agree upon to review all of your 
work to come to some kind of a conclusion if that is possible.
    So, since Dr. Wakefield and Professor O'Leary and Dr. Singh 
have all agreed, we would sure like to have yours, and I will 
be happy to write a letter, as I said before, to the 
authorities in England asking for your report, and hopefully, 
we will get that along with the others so we can review them 
side-by-side.
    Mr. Waxman. Mr. Chairman, on that point--and I want to 
agree with you.
    Mr. Burton. Sure. Mr. Waxman.
    Mr. Waxman. I drafted a letter, and I am going to share it 
with you, and I hope you will join with me on this letter to 
Secretary Shalala. We say in this letter: ``Because of the 
vital public health importance of childhood immunization as 
well as the growing concerns over the prevalence of autism in 
the United States, we urge you to convene, under the auspices 
of the National Institutes of Health, the Centers for Disease 
Control and Prevention, and the Food and Drug Administration, 
an expert panel of leading scientists and clinicians to review 
whether there is any causal association between vaccines and 
autism. Given the grave possibility that immunizations against 
life-threatening childhood diseases may decline is a result of 
unsubstantiated allegation of vaccine-induced autism, I would 
want her to act as expeditiously as possible.''
    Perhaps you will join me in this letter because I think the 
only proper thing to do is to get the experts to evaluate all 
of these conflicting claims. I would not want the American 
people as a result of this hearing to stop being immunized if 
these claims are not----
    Mr. Burton. Let me reclaim my time and say nor would I, but 
one of the concerns--the time is right there; it is on the 
clock--let me just say that the Department of Health and Human 
Services and Donna Shalala and the others have some very 
competent people over there. We have been checking into all the 
financial records of the people at FDA, HHS, and CDC, and we 
are finding that some of those people, even on the advisory 
panels, do have some possible financial conflicts, as was 
expressed in the New England Journal of Medicine just recently, 
on their front page.
    As a result, I will join with you to get an independent 
panel to review all of these studies, but I want to make sure 
they are not controlled by the health agencies of this country 
that may have some people who have some possible conflicts of 
interest. It has already been expressed in the New England 
Journal of Medicine, and we believe that that also possibly 
exists with some of the agencies of our health services here in 
the United States. So I will join with you, and we will pick 
them together, and we will try to make sure that we have some 
people who are totally unbiased.
    Mr. Waxman. Well, ``independent'' means no conflict of 
interest. I would not want a panel that had people with a 
conflict of interest, but I do want a panel of experts, and I 
think that the NIH and the CDC and the FDA can give us a panel 
that can do this evaluation. [Laughter.]
    I do not know why some people find that amusing, but I 
think----
    Mr. Burton. So long as we find there is no conflict of 
interest, we would not have any problem with that.
    Mr. Tierney.
    Mr. Tierney. Thank you, Mr. Chairman.
    I have to say that I am a bit disturbed with the nature of 
this hearing and the direction that it has gone, only because I 
have a considerable number of people in my district who have 
not only children with autism, and they deal with it every day, 
but we have a number of institutions that have been working 
hard to give people the kind of support they need to deal with 
this situation, and I find this hearing taking on a lot 
different tone than a hearing that would like to look at some 
solutions and work together in a cooperative way to find out 
just what we can do.
    I do note that Representative Michael Bilirakis from 
Florida has some legislation filed, and one of the provisions 
would authorize funding for the NIH to establish Centers of 
Excellence that would conduct basic and clinical research into 
the causes, diagnosis, detection, prevention and treatment of 
autism. I congratulate the members of this panel who are 
cosponsors on that legislation and hope that that is the 
direction in which we will proceed, because I think we need to 
find out what the causes are.
    First, Dr. Boyle, you are an epidemiologist. Given your 
background, have you examined the evidence that autism is 
increasing in the United States?
    Ms. Boyle. We do know that the rates of autism appear to be 
higher than previously thought. As I said in my testimony, they 
range from 10 to 15 per 10,000. But that is really from studies 
from other countries. We have not had prevalence studies 
conducted in the United States. There were two done in the 
eighties that found very low rates, with perhaps methodologic 
reasons for that.
    At CDC, we have begun to develop a monitoring program at 
CDC which is only for the Atlanta area. We have our first year 
of data collected, and we are in the process of reviewing the 
information on the children with autism, and we hope to have a 
rate fairly soon. And we would like to see similar activities 
in many other locations. We have a wonderful model on birth 
defects. They are many years ahead of us in terms of trying to 
understand the causes of birth defects, and there are about 35 
States that monitor birth defects on an ongoing basis. That 
does not happen for developmental disabilities, and we need to 
make that happen.
    Mr. Tierney. There are people in my district, particularly 
in the Merrimac Valley area, who seem to have at least 
acknowledged an increased number of reported cases, if not of 
autism itself, of one of the related diagnoses. Have you heard 
of----
    Ms. Boyle. It is a difficult issue because the diagnosis 
for autism has changed considerably. The first studies were 
based on fairly narrow criteria from the way it was originally 
described. The more recent studies have actually used criteria 
that are much broader, and there is increased recognition. So 
we really do not know. There have been a number of 
investigators who have tried to see whether the increase in 
rates over time, or the higher rates in more recent years, is 
really due to a real increase or sort of a redefinition and 
better awareness. It is not an easy question to answer.
    Mr. Tierney. I bring that up only because in one instance, 
at least, a group of very active parents of children with 
autism worked with the school system and some other researchers 
and heightened the awareness of identification and found a 
marked increase in the number of cases that were beginning to 
be identified in the area, so people had not really appreciated 
these symptoms, including some doctors, pediatricians, who 
looked at it.
    Does that sound right to you?
    Ms. Boyle. The one study that has addressed this is the 
study by Gilberg which I mentioned earlier, which looked at 
trends over time. If you look at the range of functioning of 
those children over time, it appeared that the increase was in 
children who were higher-functioning as well as children who 
were lower-functioning. So the classic group seemed to remain 
constant. Now, why that is happening, we do not know. That is 
what we hope to do the research to understand.
    Mr. Tierney. Well, I agree that we ought to do this 
research and do it soon. I am a little bit concerned about what 
might be the message taken from this hearing by people and what 
we want to take on this.
    Dr. Boyle, if you had young children today, would you 
vaccinate them?
    Ms. Boyle. I do have children, and they are both fully 
vaccinated, and I would vaccinate them again.
    Mr. Tierney. Dr. Offit, how about you?
    Dr. Offit. Yes. I have a 7-year-old son, Will, and a 5-
year-old daughter, Emily, and they are both fully vaccinated.
    Mr. Tierney. And you would do it again?
    Dr. Offit. Of course. I want them to be protected against 
the viruses and bacteria that can cause serious disability and 
death. I am fortunate, actually--I was a little boy in the 
early 1950's, and when I was a little boy, there were four 
vaccines--diphtheria, pertussis, tetanus and smallpox. I was 
fortunate that I was not killed by measles or paralyzed by 
polio. My son, hopefully, did not have to be as lucky, but 
hopefully, as we move into the 21st century and can develop 
vaccines against respiratory virus and para flu, children will 
not have to die from those diseases.
    Mr. Tierney. Dr. Boyle, you wanted to add something.
    Ms. Boyle. I did want to mention one thing. We do monitor 
the trend of other serious developmental disabilities in 
Atlanta, and just based on my own experience over the last 10 
or 15 years, we used to see children who were deaf due to 
congenital rubella or who had mental retardation due to 
hemophilus influenza Type B. We no longer see those children in 
our program.
    Mr. Burton. The gentleman's time has expired.
    Mr. Tierney. Thank you, Mr. Chairman.
    Mr. Burton. I just have a few more questions, and then we 
will go to the next panel--I think Mr. Waxman has a few as 
well.
    Dr. Boyle, why did the CDC ignore the pleas of the parents 
of Brick Township when they begged CDC to look at the vaccine 
issue?
    Ms. Boyle. Actually, the study of Brick Township is sort of 
our first step, which is to look at the prevalence of----
    Mr. Burton. Did you check into the vaccine issue, though? 
The parents there wanted the vaccines looked into as well. Did 
CDC----
    Ms. Boyle. The concern with the parents from Brick Township 
in a number of meetings that we had with parents was related to 
environmental concerns.
    Mr. Burton. They did not----
    Ms. Boyle. We have been working with the Agency for Toxic 
Substances and Disease Registration----
    Mr. Burton. But didn't they also ask that the vaccines that 
had been given to their children also be investigated?
    Ms. Boyle. That is not my understanding. My understanding 
is that their initial concern was to answer the question, is 
the rate of autism in their community higher than what they 
thought----
    Mr. Burton. Well, the information that we have is that the 
parents of Brick Township were very adamant that they wanted 
the vaccines checked because so many of their children had 
become autistic. And evidently, that is not one of the things 
that CDC is looking into, and I would like to pose the question 
to you and have you answer it in writing--why? Why didn't CDC 
include as one of the things they were investigating the 
possibility that some of these vaccinations may have caused the 
autism increase? Would you check that out and let me know?
    Ms. Boyle. I would be happy to.
    Mr. Burton. OK.
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    Mr. Burton. Dr. Taylor, you have shown the measles virus in 
the intestine, and you have in your laboratory--or 
``laboratory,'' as they call it in your country--you have gone 
through and checked those samples that were sent to you by Dr. 
Wakefield that show that there definitely was measles in the 
gut of these children who became autistic. I think Dr. Singh 
verified the same thing.
    Did you check any of that, Dr. Taylor, why there was 
measles in the guts of those children? Did you take a look at 
any of that?
    Dr. Taylor. I am sorry, I have not had a chance to look at 
this paper. It is interesting information. However, in terms of 
Mr. Wakefield's history, in all of his initial results, he has 
found the cure for, first of all, Crohn's disease, and he has 
found the cure for----
    Mr. Burton. Let me just ask you this--I do not want to go 
into those other things--Dr. Wakefield showed us on his slides 
that there was measles in the guts of these children who were 
vaccinated with the MMR shot. Professor O'Leary verified it in 
a separate laboratory----
    Dr. Taylor. Not in a separate laboratory; that was the same 
laboratory. That, I think, is the critical point.
    Mr. Burton. Well, it was----
    Dr. Taylor. This information does have to be verified by an 
independent laboratory.
    Mr. Burton [continuing]. It was sent to him--and Dr. Singh, 
I think, verified it as well. You have not, though, looked into 
the problem with the measles in the gut of these children, 
though?
    Dr. Taylor. I do not know quite what you mean. That is not 
my area.
    Mr. Burton. You have not checked into that; OK.
    Professor O'Leary, did you want to say something?
    Dr. O'Leary. Sir, can I make a comment, please? What I 
presented is evidence, direct evidence, cell-based and tube-
based. It was done at a separate laboratory from Dr. 
Wakefield's.
    If Professor Taylor has a beef with me, he should say that. 
My work is completely independent. I stand over it. I have come 
here to tell the truth. There is nothing for me to be gained in 
not telling the truth.
    Mr. Burton. Dr. Singh, you had some more comments, and I 
want to yield the balance of my time to you to respond.
    Mr. Singh. Yes, just a couple of things. Basically, I want 
to raise the issue that when we think about epidemiological 
studies, what are these individuals really looking at. All they 
do is they take numbers from previous, old records of what-
have-you. They do not even pay any attention to the fact that 
old-time vaccines were made based on old immunology. Today, 
immunology is so different; it is almost a difference of day 
and night. So we need to take into account that new research 
should really be evaluated by so-called expert epidemiologists.
    The second thing----
    Mr. Burton. Well, let me just say one more thing. I want to 
ask Dr. Boyle one last question, and that is do you believe 
anybody who is getting funds from Merck or any of the other 
pharmaceutical companies should be on advisory panels that are 
making judgments about pharmaceuticals coming from those 
companies, or do you believe that that is a conflict of 
interest?
    Ms. Boyle. I think that is a difficult question to answer.
    Mr. Burton. Wait a minute. Let me get this straight. You 
think it is a difficult question to answer. If somebody is 
getting funding of some type from a pharmaceutical company, for 
them to sit on an advisory panel that is approving or giving 
their approval to a new drug that is coming on the market, you 
do not see that as a conflict?
    Dr. Schwartz. Mr. Chairman, I am Dr. Schwartz. I am a 
colleague of Dr. Boyle and am the acting director of the 
Epidemiology and Surveillance Division in the National 
Immunization Program, and we appreciate your indulgence in 
allowing me to testify and to help with answering questions 
about immunization.
    The Advisory Committee on Immunization Practices is a 
chartered advisory committee under the FACA regulations. There 
are very strict guidelines regarding the participation in votes 
of members who may have conflicts of interest that will help 
assure that those potential conflicts of interest, those 
potential financial conflicts, do not affect the votes and the 
decisions of the advisory committee.
    The reason why individuals who may potentially have 
conflicts are included in the committee is to assure that we 
get the best expert advice possible so that we can make the 
best vaccine recommendations possible, and frequently, the best 
experts are those who may have done research or may have 
provided information to some of the vaccine manufacturers--but 
their role in the committee and in the voting process is very 
strictly defined.
    It is also important to point out that recommendations for 
vaccination are made independently by the American Academy of 
Pediatrics and the American Academy of Family Physicians, and 
those recommendations are virtually always in harmony with the 
recommendations from the Advisory Committee on Immunization 
Practices.
    Mr. Burton. Well, I am going to go ahead--my time is 
expired, but I am going to come back to you on that. I will 
take another round on that.
    Mr. Waxman.
    Mr. Waxman. I want to say to the parents in the audience 
and to others, family members, who are here that I do not want 
you to think that I am in any way trying to minimize what you 
have gone through or to in any way challenge the depth and 
sincerity of your feelings. I think that is a separate question 
from the scientific question of whether there is a causal link. 
And because it is so important, it is essential that through 
sound science, we determine this fact--not through emotionalism 
and not through sensationalism.
    I did not come here to say one side is right or one side is 
wrong, but I want us to have the best scientific information we 
can have.
    Now, Dr. Offit's integrity has been challenged, presumably 
because he has a point of view that does not quite fit with the 
chairman's point of view. Dr. Schwartz started to indicate why 
he thought your situation, even though you have a relationship 
with Merck, did not put you in a conflict.
    Let me ask you directly, Dr. Offit, do you have a conflict 
of interest, and if ``No,'' why not?
    Dr. Offit. No, I have no conflict of interest. What I have 
is an apparent conflict of interest, and that is why I 
disclosed that at the beginning of every ACIP meeting, and that 
is why I disclosed it in my written report.
    If I could just explain this a little bit, I have been 
doing research for 20 years on rotaviruses. What I have done in 
my laboratories is try, with my colleagues, to understand what 
the genes are that cause diarrhea and what the genes are that 
help the body fight infection. That led to a patent on a 
vaccine for rotavirus. Rotaviruses kill 13 children a day in 
this world, and rotaviruses cause 1 out of every 75 children 
born in this country to be hospitalized. It is a serious, and 
in developing countries often a deadly, infection.
    It would be an advance if we could prevent that disease. 
Merck and Company has made a commitment to developing that 
vaccine, and hopefully, if we can develop a safe and effective 
vaccine, we can prevent a lot of disease and death.
    Mr. Waxman. I think that everyone here should agree that we 
want a safe vaccine, or a vaccine that is as safe as possible. 
Merck did not hire you to come up with a particular position, 
did they? Did they tell you they wanted your research to have a 
certain outcome?
    Dr. Offit. No. This work was all done--frankly, it was 
funded by the National Institutes of Health, and it was funded 
by research that we did as a basic--I am an immunologist--that 
is my expertise.
    Mr. Waxman. There is an organization--and I am going to put 
this in the record--called the Autism Autoimmunity Project. I 
have a letter from its president urging people to give money to 
it, because this project is going to fund research that is 
going to show the connection between vaccines and autism and 
other diseases. And they proudly say they fund Dr. Wakefield 
and Dr. Singh. Is that true?
    Mr. Singh. Yes.
    Mr. Waxman. Is that true, Dr. Singh?
    Mr. Singh. Yes. I just received some money from that 
foundation, oh, about 2 months ago. My research has been going 
on on this issue for the last 15 years.
    Mr. Waxman. Yes--and I am not saying there is anything 
wrong with it----
    Mr. Singh. I just wanted to make a point on that.
    Mr. Waxman [continuing]. Although this organization seems 
to have a particular point of view. How would you think they 
would feel if your research came up with a different conclusion 
from what they wanted to achieve in their--because they have a 
position----
    Mr. Singh. Mr. Waxman, I am a very honest, decent human 
being--unlike, perhaps, some other people that you might know 
of--and I can tell you that if I found a connection which was 
not existent or if my results did not support what this 
foundation wanted, I would even return the money to that 
foundation.
    Mr. Waxman. Even though they want a particular point of 
view----
    Mr. Singh. They never asked me to do any research----
    Mr. Waxman [continuing]. You are an independent scientist, 
and you have integrity.
    Mr. Singh. What I am----
    Mr. Waxman. Just answer yes or no, because I do want to 
ask----
    Mr. Singh. I beg your pardon?
    Mr. Waxman. My question to you is they have a point of 
view, but they fund you, you have integrity, and you are going 
to do your work based on science. Is that your answer?
    Mr. Singh. My answer is that I am getting funds from 
private sources because national agencies continue to decline 
my research grant proposals when I submit. Where else am I 
going to go to get the funding?
    Mr. Waxman. Have you been turned down by NIH?
    Mr. Singh. I am trying to raise funding independently, on 
my own, not necessarily----
    Mr. Waxman. Have you been turned down by NIH?
    Mr. Singh. Three times, I have attempted--three times, I 
have written grants, and NIH has not given me a single dime.
    Mr. Waxman. I want Dr. Wakefield to be able to answer the 
same question very briefly.
    Dr. Wakefield, you acknowledge you have received money. Do 
you feel that that in any way raises expectations that your 
research come out with a result that this organization wants?
    Dr. Wakefield. We are funded to test hypotheses, and we 
present the data whether the hypothesis is correct or not. And 
we have done that, we have gone on record as doing it. We 
publish negative studies in association with measles and 
Crohn's disease. That does not mean it is not there; it means 
that our hypothesis was wrong in terms that we could not find 
it using the technology. So we have gone on record as 
publishing both positive and negative data.
    Mr. Waxman. I ask unanimous consent that those documents 
from the Autism Autoimmunity Project be put in the record, and 
I would note, Mr. Chairman, that you are also associated on the 
board of this group.
    Mr. Burton. Without objection. That is no problem.
    [The information referred to follows:]
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    Mr. Burton. I see this as a little bit different situation. 
The pharmaceutical companies who are producing jobs--and they 
do a great job for the country--but they have a financial 
interest in getting things approved.
    The New England Journal of Medicine has recognized this in 
a recent publication, on the front page. They said that they 
had some people on their advisory committees who had made some 
comments and made some recommendations that had financial 
interest, and they had not scrutinized them properly, and they 
apologized for it and said it would not happen again.
    So what I asked Dr. Boyle and what I am inferring here 
today is that there can be a bias if people are being paid or 
reimbursed by pharmaceutical companies when they start making a 
decision or a recommendation on an advisory panel.
    Now, you said that if they represent Merck or Bristol 
Meyers or some other laboratory, they will probably excuse 
themselves from voting, and there may be a requirement for 
that. That does not alter the fact that they are sitting on 
that panel, and they are talking to everybody else on that 
panel, and they have influence on that panel, and they do have 
a tremendous impact on whether or not certain things are 
approved or disapproved. And I think that that is a conflict of 
interest. I do not see why we cannot have people on advisory 
panels who have no financial interest whatsoever with 
pharmaceutical companies when they are approving those, because 
we are talking about the health of the Nation. And that is 
something which ought to be investigated very thoroughly by 
this Congress.
    We are talking today about autism, but there is something 
of as great stake here as the autism question and whether or 
not the MMR vaccine and other vaccines may be contributing to 
autism, and that is are we letting pharmaceutical companies 
have too great an influence on the decisionmaking process that 
affects very one of our lives?
    Right now, we are talking about the anthrax vaccine. They 
are going to inoculate every one of our military personnel, and 
there are all kinds of questions about the anthrax vaccine, all 
kinds of them. We have had all kinds of side effects that we 
have talked about, and I have talked to people who have had 
them. And the former chairman of the Joint Chiefs of Staff is 
on the board of that company that makes the anthrax vaccine. 
They are manufacturing millions of doses of this vaccine, and 
every member of the service will have to get six shots of that. 
If the decisionmaking process involves people who have a 
financial interest in it, and that outweighs the potential side 
effects of any drug, then I think there is something amiss.
    So I have great concerns about that, and I would just say 
to you that HHS and CDC and FDA and all of them ought to take a 
hard look at whether or not they have people on their advisory 
panels who have a potential conflict of interest by getting 
money or something else from a pharmaceutical company that they 
represent.
    Now, I was not trying to impugn the integrity of Dr. Offit, 
but I did want to point out that he does get money from Merck 
and gets some benefits from Merck. So for anybody to say that 
he can be totally unbiased is questionable. Maybe he would be 
totally unbiased, but it is questionable.
    So I think that this whole issue of whether or not the MMR 
vaccine is a problem--the measles vaccine has been found in the 
gut, it has been verified, and we still have this problem, and 
the question was whether or not it goes from the gut up to the 
brain and is a contributing factor to autism--but the companies 
that make the MMR vaccine have people on the advisory boards 
who are participating in the decisionmaking process.
    So it makes me wonder whether we are going to really get to 
the bottom of it unless we go to outside entities--and that is 
not questioning anybody's integrity. It is just saying that if 
I am paying somebody money for some product or something, and 
there is something else that I am going to make money off of, 
and they are on a board that is going to participate in a 
decisionmaking process, to say that they do not at least think 
about me and think about where the money is coming from just 
boggles my mind, and I think it would most people.
    With that, do I have any further questions? Let us see what 
else we have here.
    [Pause.]
    Mr. Burton. OK. Dr. Boyle, for your information, at a 
public meeting in Brick Township in January 1997--and you 
should know this--with CDC and others present, several audience 
members asked about the vaccines and the possible autism link, 
and they asked that vaccines be checked. That is from Andy 
Napoli, the legislative director of Representative Chris Smith.
    So, I again want to stress that we want to have an answer 
from CDC. If parents from that township were wondering about 
the possible connection between these vaccinations and autism, 
why didn't CDC check on it? Why not? You are checking on 
everything else, the other environmental concerns around there. 
Why not check on the vaccine?
    And I submit that maybe, just maybe, it is because the 
pharmaceutical company that manufactures it had some influence 
on the people who were in that meeting, and they said, Hey, we 
do not want to get into that. And if that is the case, that is 
damned near criminal.
    With that, I will be happy to yield back the balance of my 
time and let Mr. Waxman have his 5 minutes. Then we will go to 
the next panel.
    Mr. Waxman. Thank you, Mr. Chairman.
    I would like to have Dr. Spiker come forward, if he would.
    Dr. Spitzer. Spitzer. S-p-i-t-z-e-r.
    Mr. Waxman. Oh. I am sorry. Dr. Spitzer, where are you----
    Dr. Spitzer. I am a professor of epidemiology with the 
Faculty of Medicine at McGill University in Montreal.
    Mr. Waxman. When you came forward a moment ago, you 
appeared to be reading from a prepared statement. Did you have 
a statement written out that you read from?
    Dr. Spitzer. Yes, I did. The circumstances are that I 
personally learned of this hearing, and of related activities 
very late in the game. I have been an honorary assistant to 
2,100 families in the United Kingdom who have great difficulty 
getting scientific help and cannot afford it. I have chosen on 
this issue----
    Mr. Waxman. Excuse me. Did you prepare that statement 
yourself before the hearing?
    Dr. Spitzer. Yes, I did.
    Mr. Waxman. OK. And were you contacted or did you contact 
Chairman Burton's staff before your testimony?
    Dr. Spitzer. I did so indirectly, to the best of my 
knowledge, through a person named Ms. Barbara Fisher.
    Mr. Waxman. And could you identify Barbara Fisher? Is she 
here?
    Dr. Spitzer. She is here in the audience.
    Mr. Waxman. Is she a staffperson for the committee?
    Dr. Spitzer. No. She is in the vaccination----
    Mr. Waxman. When did you talk to her? Was it today or 
earlier than today?
    Dr. Spitzer. I spoke to her yesterday and the day before 
yesterday by telephone and met her here----
    Mr. Waxman. And you met her here?
    Dr. Spitzer. I met her this morning.
    Mr. Waxman. But you talked to her yesterday and the day 
before about coming here to testify?
    Dr. Spitzer. Yes.
    Mr. Waxman. Thank you very much.
    Dr. Offit----
    Dr. Spitzer. I am sorry. It was primarily for the press 
conference, but with the possibility of being able to testify 
as well.
    Mr. Waxman. Yes--some extenuating circumstances for which 
the rules did not have to be observed.
    Dr. Offit, the chairman says he is not impugning your 
reputation, but it sounds to me like your reputation has been 
impugned. You get money from Merck. They make the vaccine. You 
are on an advisory committee for the CDC about vaccines. That 
is an apparent conflict of interest. Again, why isn't it a 
conflict of interest?
    Dr. Offit. Because as I sit on the Advisory Committee on 
Immunization Practices and make recommendations for children in 
this country, the only thing I consider is exactly how I would 
treat my own children. I mean, I take the job very seriously. 
So the recommendations that I make are based solely on a 
careful review of the data that are presented to us, period. I 
do not have any conflict with regard to that decisionmaking 
process. It is simple in that sense.
    Mr. Waxman. Dr. Boyle and Dr. Schwartz, what would happen 
if you excluded people from your advisory committee who worked 
in the area of research on vaccines or in some other area for a 
pharmaceutical company?
    Dr. Schwartz. Those with the greatest expertise on vaccines 
and those who are best able to make recommendations that will 
protect the health of American children have frequently done 
research in vaccines. They are the ones who know the issues 
best and who can make the best recommendations. By including 
them on the advisory committee, but implementing appropriate 
controls to make sure there are no apparent conflicts of 
interest, the CDC feels that they get the best advice to make 
the best public health recommendations.
    Mr. Waxman. How about people who are funded by the Autism 
Autoimmunity Project--have you ever heard of that group?
    Dr. Schwartz. The ACIP meetings are all open public 
meetings. They are all----
    Mr. Waxman. What is ``ACIP?''
    Dr. Schwartz. The Advisory Committee on Immunization 
Practices meetings are all open meetings and are announced in 
the Federal Register. If someone from that particular institute 
wanted to come and share information or present to the ACIP, 
they would certainly be welcome to do so.
    Mr. Waxman. And would you feel they have a conflict of 
interest if they are funded by an organization that wants to 
have scientists establish a certain conclusion?
    Dr. Schwartz. I think the most important thing that we need 
to consider is the quality of the scientific data and whether 
those data have been peer-reviewed, whether they have been 
considered by other scientists, and whether they have been 
replicated in other laboratories.
    Mr. Waxman. So you think the most important thing is that 
Dr. Wakefield and Dr. Singh ought to disclose if they are 
funded by this group, and Dr. Offit ought to disclose if he is 
funded by Merck.
    Dr. Schwartz. I think disclosure is important, yes.
    Mr. Waxman. And then you evaluate their science?
    Dr. Schwartz. Yes.
    Mr. Waxman. Because ultimately what is at stake are the 
scientific questions that we want answered.
    Dr. Schwartz. That is exactly correct, and preserving the 
health of American children.
    Mr. Waxman. Well, that, it seems to me, should be the goal 
of all of us, and I hope that hearings like this are to try to 
get to that result and not simply to further a particular point 
of view which could well be wrong, and if it is wrong, as I 
fear it may be, by advertising this particular point of view 
and scaring the public, we could see a drop in immunization 
rates. And we do not know if autism will drop--in fact, we have 
evidence from Great Britain that it did not drop when 
immunizations did----
    Mr. Burton. I am allowing you extra time because I have one 
more question. I am allowing you extra time.
    Mr. Waxman [continuing]. I am getting extra time--for good 
behavior--that when we do have an example in the real world of 
sensational press about the link between autism and 
vaccinations, vaccination rates dropped, and we knew that 
caused an increase in measles, but we saw no decrease in 
autism.
    It is troubling to me. I appreciate all of the views that 
have been expressed here, and I hope that we can get an 
independent group to look at this, because I do not think this 
committee is an independent group trying to reach an honest 
conclusion.
    I yield back the balance of my time to the chairman.
    Mr. Burton. Let me just make one final comment, and that is 
that the people who are doing the independent studies here do 
not sit on any advisory boards that are making decisions on 
what kinds of vaccinations we are going to be giving to the 
people of the United States of America. The people who 
represent the pharmaceutical companies and sit on those boards 
do. That is the difference.
    And let me just conclude by saying that I really appreciate 
all of you being here. This is a very difficult issue. I think 
it was unavoidable that there would be this kind of contention 
today because we have a lot of parents and grandparents, like 
myself, who feel very strongly about the life that our kids and 
grandkids are going to have to lead; and on the other side of 
the issue are the people who are saying there is no impact from 
the shots that are being given to our kids.
    So the bottom line is that there are going to be strong 
differences of opinion, and we want to get all those 
differences of opinion on the record, and then we will all go 
out and have a cup of coffee together and debate it in private.
    The American people need to know the facts. Lincoln said, 
``Let the people know the facts, and the country will be 
saved,'' and I think that is just as true today as it was at 
the beginning of this Republic. So that has been our goal--not 
to fight with everybody, but to get the facts out. And we are 
all for vaccinations. It is just do we want to give a child 
nine vaccinations in 1 day; do we want to give them 31 or 32 or 
33 vaccinations between the time they are born and age 6? Isn't 
that maybe a little bit of overload? That is the whole 
question.
    I want to thank this panel. We have one more panel. I 
really appreciate all of you being here, even though we may 
have some differences with some of you.
    Thank you.
    I apologize to the next panel for having to sit there for 
so long.
    While the next panel is coming up, we will take a couple-
minute break. The next panel consists of Dr. Bernard Rimland, 
Dr. Michael Goldberg, Dr. Mary Megson, Dr. John Upledger, Dr. 
Catherine Pratt, Dr. Deborah Hirtz, and Dr. Edward Cook.
    We will start in just 1 minute.
    [Recess.]
    Mr. Burton. The committee will reconvene.
    Would everybody please take their seats and shut the doors, 
please?
    I appreciate very much your patience today. Would the panel 
please rise?
    [Witnesses sworn.]
    Mr. Burton. Have a seat, please.
    We will start with you, Dr. Rimland.

     STATEMENTS OF BERNARD RIMLAND, Ph.D., AUTISM RESEARCH 
 INSTITUTE, SAN DIEGO, CA; DR. MICHAEL J. GOLDBERG, DIRECTOR, 
 NIDS MEDICAL ADVISORY BOARD, TARZANA, CA; DR. MARY N. MEGSON, 
 PEDIATRIC AND ADOLESCENT ABILITIES CENTER, RICHMOND, VA; DR. 
JOHN E. UPLEDGER, THE UPLEDGER INSTITUTE, CLEARWATER, FL; CATHY 
 L. PRATT, INDIANA RESOURCE CENTER FOR AUTISM; DR. DEBORAH G. 
 HIRTZ, NATIONAL INSTITUTES OF HEALTH; DR. EDWIN H. COOK, JR., 
                     UNIVERSITY OF CHICAGO

    Mr. Rimland. Thank you very much for the opportunity to be 
here. It is a great honor and a great privilege.
    I want to start by commenting that there has been a lot of 
discussion during the past few hours about the supposedly 
unproven hypothesis that vaccines may cause autism. There is 
another unproven hypothesis which has been unchallenged and 
unquestioned, at least relatively so, and it is really a very 
important hypothesis, and that hypothesis is that vaccines are 
safe.
    The real hypothesis which should have been tested years and 
years and years ago by much more scientific research than has 
ever been devoted to it is the proposition that vaccines do not 
cause damage. The Vaccine Information Adverse Reaction 
Reporting System has not been studied; it has not been looked 
at at all carefully, and therefore, the assumption that many 
people are making is that the vaccines have been looked at 
carefully for adverse reactions, and they have not been.
    The other point I want to make has to do with the testimony 
of Dr. Brent Taylor, who spoke here on the last panel. I was 
very bothered by the lack of information and the confusing 
information in his paper. My entire life has been spent as a 
professional researcher--almost 50 years of my life has been as 
a full-time professional researcher. I am a fellow of the 
division of statistics, measurement and evaluation of the 
American Psychological Association.
    I wrote a friendly letter to Dr. Taylor indicating that I 
would very much like to take a look at his data, because I did 
not understand part of it, and there were some questions that I 
wanted to raise. He ignored my first letter. I sent a second 
letter, and he responded to that by saying no, I could not have 
a look at his data.
    I then wrote to the editor of the Lancet urging that a 
blue-ribbon committee be appointed to take a very close look at 
the data of Dr. Taylor. So I am delighted that you have asked 
for it as well.
    My own son Mark was born in 1956 as a severely autistic 
child from birth. Our pediatrician, who had been in practice 
for 35 years at that time, had never seen such a child or heard 
of such a child.
    When Mark was 2, my wife and I found the word ``autism'' 
for the first time in a textbook. I was at that point 5 years 
beyond my Ph.D. in psychology, never having heard of or seen 
the word ``autism'' before. It obviously was a very rare 
disorder, extremely rare. None of us had heard of it.
    Today it is extremely common. There is hardly a high school 
kid in the country who has not heard of autism. It is a 
household word now, and that is not because of the movie ``Rain 
Man,'' but because it is extremely prevalent.
    Despite denials from some experts, there is a terrible 
worldwide epidemic of autism. In the mid-1960's, after my book 
``Infantile Autism'' was published, I began hearing from 
parents throughout the world whose children had been normal 
until given the DPT shot. I began to make note of it and ask 
questions about it in the form letters I sent out to parents 
seeking information about autism.
    In the past few years, the Autism Research Institute, which 
I direct in San Diego, has been flooded with letters and faxes 
about children whose parents say and can prove very well with 
videotapes and photos that their kids were normal until getting 
another triple vaccine, the MMR shot. In my view, the evidence 
is overwhelming that vaccines, especially the triple vaccines, 
and among the triple vaccines especially the MMR, can and do 
cause many cases of autism.
    It is also alarming but true that 90 to 99 percent of 
adverse reactions to vaccines are never reported. There is no 
penalty for a doctor's failure to report a bad vaccine 
reaction, so they simply do not do it. Why should they engage 
themselves in paperwork if there is no requirement that they do 
it and no penalty for not doing it?
    This being so, how can the authorities claim that the 
vaccines are safe, given that only 1 to 10 percent of adverse 
events are ever reported? Doctors must be trained to recognize, 
and required, not just requested, to report adverse events.
    With regard to the question of genetics, they say that 
autism has a large genetic component, and therefore, vaccines 
must play a minimal role. My book, ``Infantile Autism,'' 
published in 1964 was the first systematic attempt to marshal 
the evidence for a genetic relationship to autism, so I am 
certainly not hostile to that idea. However, genes do not begin 
to account for the huge increase in the incidence of autism. 
There is no such thing as an epidemic due to gene problems. The 
increase ranges from 250 to 500 percent in various places, as 
other people have pointed out here.
    As the editor of the Autism Research Review International, 
I have just reviewed a very large number of studies on the 
genetics of autism. The next issue of the Autism Research 
Review is going to contain our review study. The results of our 
review are spectacularly inconsistent. The best guess is that 
there are at least 20 different genes that may be involved in 
the causation of autism. Genes are not the answer to the 
question, even though, at one time, I was very much in favor of 
looking at that hypothesis. I am still interested in the 
hypothesis, but it is certainly not responsible for the 
increase in autism.
    The people who claim that the vaccines are safe claim that 
autism naturally occurs at about 18 months, when the measles/
mumps/rubella vaccine is routinely given, so the association is 
merely coincidental and not causal. But the onset of autism at 
18 months is a recent development. Autism starting at 18 months 
rose very sharply in the mid-1980's, when the MMR vaccine was 
introduced. For the previous 30 years--we have been collecting 
information from children born in the fifties, sixties, 
seventies, and so forth--there were twice as many kids reported 
with the autism started at birth as there were kids whose 
parents reported that the autism started at 18 months.
    Starting in about the 1980's, when the MMR vaccine was 
introduced, those two curves converged. Over a period of 
several years, the number of kids whose autism started at 18 
months rose to twice as high as the number starting at birth. 
On the last page of my handout, I have a graph that shows those 
curves based on the records of over 31,000 children in our San 
Diego institute. So that particular argument against the MMR 
hypothesis is obviously a very poor one.
    Autism is not the only severe chronic illness which has 
reached epidemic proportions, as the number of very profitable 
vaccines has rapidly increased. Children now receive 33 
vaccines before they enter school--a huge increase. The 
vaccines contain not only live viruses, but also very 
significant amounts of highly toxic substances such as mercury, 
aluminum and formaldehyde. Could this be the reason for the 
upsurge in ADHD, asthma, arthritis, Crohn's disease, lupus, and 
other chronic disorders? It seems as though we are trading 
protection against acute diseases such as measles and mumps for 
a huge epidemic of chronic diseases like autism, asthma, and 
the others I mentioned.
    As a parent and a full-time professional researcher, I am 
bitterly disappointed with the medical establishment's dismal 
record with regard to autism over the past 60 years. The 
medical schools as well as the Government agencies have 
consistently supported outmoded, unproven and even disproven 
ideas, including the one that autism was caused by 
``refrigerator mothers'' who did not love their children, thus 
causing autism. The medical establishment was opposed to 
behavior modification, or what is now called the ABA approach. 
They said that this was not a way to treat autism, because 
autism was based on deepseated emotional problems, so a 
technique that is used to train animals cannot be used to 
improve autistic children. That was untrue. They have ignored 
and continue to ignore the long series of studies conducted 
both in the United States and Europe showing that the 
elimination of foods containing gluten and casein from the diet 
brings about marked improvement in many autistic children. They 
have consistently ignored the series of 18 consecutive studies 
conducted by researchers in six countries which show that 
almost half of all autistic children and adults respond 
favorably to high doses of Vitamin B6 and magnesium, with no 
adverse reports from any of these studies. Eleven of these 
studies were double-blind placebo-crossover experiments. There 
is no drug which comes even close to B6/magnesium in terms of 
safety, efficacy, and positive research findings, yet it is not 
being explored at all.
    Tens of millions of dollars have been spent on 
nonproductive lines of research while virtually no money at all 
has been given to research on methods of alternative medicine 
which are far more promising in terms of both safety and 
efficacy.
    The most interesting questions are not being asked. Why 
does the majority of any population survive such epidemics as 
autism, the bubonic plague, Legionnaire's disease, polio and 
AIDS, while relatively few succumb?
    The very obvious answer and the most probable answer is 
that the survivors have healthy, effective immune systems. 
Would enhancing the immune system decrease the likelihood of 
adverse reactions to vaccines--including, by the way, the 
anthrax vaccine. I hope that DOD will pay some attention to 
that. There is good reason to think about anthrax in this 
context.
    It is well-known that the immune system must be adequately 
supplied with many nutrients if it is to function properly, 
including especially Vitamins A, C, E, B6, and a number of 
minerals, including zinc, magnesium, and selenium. Nutritional 
levels of these substances are not only harmless, but they are 
essential to good health.
    Since people do not change their diets readily, I believe 
that foods should be fortified with these nutrients, especially 
foods which will be consumed by infants and children. Research 
along these lines, as well as on the safety of the vaccines, is 
desperately needed.
    Recently, Professor Clementson published a paper--he is the 
author of a three-volume treatise on Vitamin C--reviewing the 
evidence showing that individuals who are vaccinated without 
having adequate supplies of Vitamin C in their bodies are far 
more likely to suffer an adverse reaction to the vaccine than 
those who have higher levels of Vitamin C.
    Dr. Archie Kalokerinos of Australia, a pediatrician 
assigned by the Government to the outback people there, found 
an infant death rate of 50 percent among the children he cared 
for. They died soon after the vaccines. He found that they were 
extremely Vitamin C-deficient, and he learned that by giving 
them some extra Vitamin C, he could prevent their deaths. The 
death rate went from 50 percent to zero in a very short time. 
Dr. Kalokerinos was given a medal by the Australian Government.
    We should be giving our children Vitamin C as well as other 
nutrients to make sure that their immune systems are well-fed 
and function well. I think we would see a lot fewer of the 
problems that we are experiencing today.
    As a parent and as a researcher, I believe there should be 
a marked redirection of effort and funding along the lines 
suggested above.
    Thank you.
    Mr. Burton. Thank you, Dr. Rimland. I appreciate your 
comments.
    Dr. Goldberg.
    [The prepared statement of Dr. Rimland follows:]
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    Dr. Goldberg. Mr. Chairman and members of this committee, 
thank you for allowing me the opportunity to speak here today. 
I wish to take a moment to examine the urgency of this 
epidemic.
    I am Dr. Michael Goldberg, a practicing pediatrician for 
over 20 years in Los Angeles, and I am on the clinical teaching 
staff of UCLA. I am also the founding member of the NIDS 
Research Institute, a parent-physician partnership developed to 
expedite research on behalf of children with special needs.
    Out of necessity and a desire to help, my practice is 
comprised primarily of children with autism, ADD, and other 
special needs. I am here before you today to share my 
frontline, everyday experience with these children, experience 
that has overwhelmingly convinced me and my colleagues that 
this is a disease that can be treated.
    In turn, I hope to propose a unique medical research model 
that combines the tenets of basic science and strong academics 
with an unprecedented sense of clinical urgency.
    To understand this new autism that everyone keeps speaking 
about, one must actually step back and look at the increased 
understanding and incidence of autoimmune diseases across the 
board from the mid-1970's to the present date. All that one has 
to do is look at the medical literature to realize that every 
disorder we have associated as an immune-connected, immune-
mediated defect of the immune system--lymphomas, multiple 
sclerosis, Alzheimer's, lupus, ulcerative colitis, irritable 
bowel syndrome, rheumatoid disease, and even aging--have all 
become recognized as in part an autoimmune process or illness. 
As Dr. Galpin, an authority in infectious disease immunology 
and a pioneer in the application of immune-modulators and a 
member of the NIDS Medical Board likes to say: The friendly 
fire of our own bodies causes the damage.
    We either have to assume that the increase in these 
disorders in the human population is mass hysteria, mass 
psychosis, schizophrenia and/or behavioral-developmental 
disorders, as was thought in the old days, or we need to step 
back and realize that maybe we have a large number of adults 
and children suffering a disease process that is affecting how 
their brain and nervous system functions. I have family after 
family within my new practice in which there is a mother or a 
father with chronic fatigue syndrome, an older child with ADD/
ADHD, and a young child or two with autism/PDD.
    Unless we assume that this is all random, unfortunately, 
there is a logical connection between the above disorders and 
the rapid emergence of this crisis. We must rapidly realize 
that almost all of these disorders result from a treatable 
disease process.
    When you look at the factors among the children that I am 
seeing, many of them have low natural killer cells. These are 
part of the findings being reported in many of those other 
disorders. Another frequent finding is the presence of active 
HHV-6 virus and other related herpes viruses in some of these 
children. Similar findings are being reported for various adult 
autoimmune disorders, and recently, even the Centers for 
Disease Control published an article focusing on our emerging 
knowledge of HHV-6 and related disorders.
    Fortunately, while people talk about the unknown entity of 
autism, I can show you picture after picture after picture that 
has allowed me with the help of researchers, Dr. Ismael Mena 
and Dr. Bruce Miller, to look at NeuroSPECT scans and 
understand what is going on in the brains of these children. 
For the majority, there is a decrease of blood flow and 
function of the temporal lobe of the brain, areas that are 
consistent with that predicted by neuro-anatomists.
    We have a large collection of scans that show a decrease in 
blood flow that is reproducible, quantifiable. Blood flow 
corresponds directly to function. When compared to MRIs and 
CAT-scans, they help to confirm no pre-existing damage but 
rather point toward a neuro-immune direction etiology. In fact, 
as we learn more through imaging and scans and technology about 
the brain, in a recent New England Journal of Medicine article 
a year ago, they discussed the immune-brain-endocrine 
connection in the hippocampus, a system that, with the CA1 and 
CA2 nuclei and neuron, affects cognitive function, fatigue, and 
memory.
    Today I have come to look upon this as a reversible 
condition. Thankfully, many children return to normal/above 
normal functioning by combining steps reflecting diet control, 
a combination of antivirals, antifungal, and low-dose SSRIs.
    Parents who are told that their children will never be 
independent, will never be able to earn a living, will 1 day 
might have to be placed in an institution, have seen their 
children become top of their class academically. I have 
children within the practice scoring in the 97th and even the 
99th percentile in California and Illinois State testing. This 
past week, a mother came to me with her 5-year-old child, who 
has been with me in the practice for about 8 months. She 
related an instance where the child said, ``Mom, do you want me 
to pretend I cannot talk? Remember when I could not talk?''
    We have so misunderstood and misjudged these children. What 
harm are we doing to these children as a result?
    Hopefully, tomorrow, we will see new agents which will let 
us work better with the immune system. If we can focus a 
unified effort to identify a subspecialized set of immune 
markers, that will let us understand which patient is the most 
likely candidate for which immune agent, separate out this 
mixed group of children into logical subgroups.
    In my written submission to the committee, the NIDS Medical 
Board outlines a hypothesis which is supported by over 60 
journal references on children with autism and the neuro-immune 
disease process that is potentially reversible.
    It is interesting to note that that hypothesis has been 
reviewed by at least four pharmaceutical companies, and there 
are no holes or deficits in that hypothesis.
    Within the NIDS Institute, our researchers are all heavily 
credentialed, and many are involved in current NIH projects and 
other activities at the NIH and the FDA. Using this technology, 
their past experience, and a computerized data base, we can 
unify researchers in institutions across the country. We can 
literally pick and choose top physicians and researchers around 
this country and around the world to focus on the crisis it has 
become.
    For instance, I am pleased to announce that members of the 
Mind Institute are hopefully looking at joining and combining 
efforts, and my hope would be that many independent groups can 
focus in a scientific manner on answering the questions being 
raised by this committee today.
    Another significant benefit of exploring this disease 
process with a sense of urgency would be the unprecedented 
ability to screen children who might be susceptible to vaccines 
or any other factors which have been implicated as potential 
roles in subsets of these children. Any injury or loss of a 
child that could have been prevented remains unacceptable. 
There is no way to adequately console the parent of a lost or 
damaged child.
    If focused correctly, we do have the ability to accelerate 
understanding and identification of potentially high-risk 
children. If we can identify these children, adjust their 
vaccine schedule appropriately, we have begun the process of 
stemming this epidemic and will have created a preventive 
health policy which would be part of a collective legacy for 
generations to come.
    In 1996, I was a speaker at the Autism Society of America, 
attended by over 2,000 parents and professionals. My wife made 
the comment: ``Where are the M.D.s?'' The medical community had 
essentially abandoned these children once they became labelled 
as autistic.
    The NIDS Medical Board is designed to help logically, 
academically, scientifically circumvent the expected learning 
curve as we see physicians coming back into this field make a 
radical shift in direction and orientation from what we might 
have been taught as physicians.
    I plead with you, Mr. Chairman and members of the 
committee. These children are supposed to be a productive part 
of this country's future, not a health cost and burden. These 
children have the potential for full, productive, intelligent 
lives. Contrary to the old idea, their genetics are not the 
determining factor. A child cannot develop normally, develop 
some language, and lose it all, except in a disease process. We 
can apply good, sound science and logic to help solve the 
crisis now.
    We must embrace what is literally a paradigm shift in the 
world of medicine and begin to view autism and other related 
classifications like we do Alzheimer's disease, cystic 
fibrosis, childhood cancer, and multiples sclerosis. 
Tragically, if we accept the status quo, we will be sacrificing 
millions of kids and will likely lose more in subsequent 
generations.
    I implore you to investigate the concepts I have 
introduced, evaluate them, test them--do whatever it takes to 
convince you that we have a crisis for which inaction is 
politically and medically more risky than action.
    I am extremely fortunate to have three healthy children and 
one healthy grandchild. I selfishly want the rest of my future 
grandchildren, all of yours, and others out there to have the 
same chance.
    Thank you.
    Mr. Burton. Thank you, Dr. Goldberg. As I think you can 
probably guess, we are going to pursue this for a long time.
    Dr. Goldberg. I hope so.
    [The prepared statement of Dr. Goldberg follows:]
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    Mr. Burton. Dr. Megson.
    Dr. Megson. Mr. Chairman, members of the committee, my name 
is Mary Megson. I am a board-certified pediatrician, 
fellowship-trained in child development, a member of the 
American Academy of Pediatrics and on the clinical faculty at 
the Medical College of Virginia.
    I have practiced pediatrics for 22 years, and the last 15 
years, I have worked only with children with developmental 
disabilities, which include learning disabilities, attention 
deficit hyperactivity disorder, mental retardation, cerebral 
palsy, and autism.
    In 1978, as a resident at Boston Floating Hospital, I 
learned that the incidence of autism was 1 in 10,000 children. 
Recent surveys have suggested an incidence in several parts of 
the country of between 1 in 300 and 1 in 600 children.
    Over the last 9 months, I have charts now in an office that 
I opened last June on 1,900 patients, well over 1,200 of whom 
have fullblown criteria for autism. I have 70 autistic children 
in a clinical trial and I am beginning a second clinical trial 
to look at treatment on these children.
    At the same time, the State Department of Education says 
there are only 1,522 children with the diagnosis of autism in 
the State of Virginia.
    Mental health and mental retardation agencies have 
scrambled to set up infant intervention programs and have had a 
hard time keeping up with the numbers of delayed infants and 
toddlers. I have served as an advisor for the city of Richmond 
and the surrounding counties as they set up these infant 
programs and also set up special education programs for 
children with autism. Now there are autistic classes in each 
county and several classes in several schools. There has been a 
very rapid rise over the last several years, The segment of 
children with ``regressive autism''--who develop normally and 
then regress usually between 18 and 24 months--has increased 
dramatically. This past week, I was involved in four cases of 
children who were perfectly normal in their development until 
they had their school-age shots at age 5--DPT, hepatitis 
vaccine, MMR. Within weeks, they were autistic. In the past, 
this was unheard of.
    In the vast majority of cases, I have discovered that one 
parent or another reports night blindness or other rare 
disorders associated with a defect in something called a G 
protein. G proteins are proteins inside the cell that join 
receptors that sit in the cell membrane. They are cellular 
proteins that upgrade or downgrade signals in their sensory 
systems all over the body that regulate touch, taste, smell, 
hearing, and vision. They are important also in turning on or 
off multiple metabolic pathways, including those for glucose, 
lipid, protein metabolism. They also turn on and off pathways 
for cell growth differentiation and survival.
    Close to the age of autistic regression, we are adding a 
second defect to the G protein--namely, pertussis toxin--which 
completely disrupts these G protein pathways. The opposite G 
protein pathways are on without the off switch.
    In my research, I have discovered that some children are 
protected if they have the lipid-soluble form of Vitamin A, 
that's found in natural sources. Those children, especially 
those who are breast-fed--get the early vaccines in spite of 
having the genetic defect and do fine. However, the measles/
mumps/rubella vaccine at 15 months of age depletes the body of 
all Vitamin A. When they get the DPT the same day or several 
months later, many of these children disconnect.
    There are several metabolic problems that I am seeing 
repeatedly in these children. The pathway to break down the 
storage form of glucose in the body is on without opposition. 
These children have elevated blood sugars. In the past week, I 
have been made aware of four cases of autistic children who 
developed juvenile onset diabetes. There is a 68 percent 
incidence of diabetes in the parents or grandparents.
    Lipid breakdown is turned on without opposition. I have 
diagnosed many 2\1/2\-year-old children with autism who have 
serum cholesterol of 240 and above. There is an incidence in 
one of three of these families of heart attack of a parent or 
grandparent under age 55 and diagnosed with hyperlipidemia.
    Of great concern, cell growth, differentiation, and 
survival is turned on, which leads to uncontrolled cell growth. 
In the first 60 families I examined, there were 62 cases of 
malignancies associated with the RAS oncogene.
    I have also discovered that the measles antibody that the 
body makes, once they are exposed to the measles vaccine, 
cross-reacts with intermediate filaments. Intermediate 
filaments are the glue that hold the cells that line the gut 
wall together, so when they get that MMR vaccine, they develop 
a leaky gut. Intermediate filaments are also important in areas 
of high stress. One of the areas of highest stress in the human 
body is the upper small intestine right below the stomach. They 
develop a chronic autoimmune disorder at that point.
    The loss of the cell-to-cell connection also occurs in the 
blood-brain barrier and in the cells that surround the bite 
annicul: where toxins are excreted from the body. So any toxins 
that they are exposed to, leak through the gut wall, and they 
cannot pump them out of the body.
    The loss of cell-to-cell connection interrupts another 
process in the body which is very important called aproptosis, 
or the ability of neighborhooding cells to get rid of abnormal 
cells. The MMR vaccine at 15 months precedes the DPT vaccine, 
which turns on uncontrolled cell growth differentiation and 
survival.
    Most families have reported cancers in parents or 
grandparents. The genetic defect found in 30 to 50 percent of 
adult cancers is a cancer gene, the RAS oncogene. This is the 
same defect that is the defect for congenital stationary night 
blindness.
    In Harrison's Textbook of Internal Medicine, which is the 
standard textbook in medical schools all across this country, 
it is stated that it is absolutely contraindicated to give the 
MMR vaccine or a measles vaccine in the face of Vitamin A 
deficiency. I am afraid that some of these children are facing 
that vaccine when they are already deficient in their Vitamin A 
stores, and then they cannot reconnect pathways.
    Most of us in our current diets have the lipid-soluble form 
of Vitamin A taken out. This lipid-soluble form is found in 
liver, kidney, milk fat and cod liver oil. In lowfat milk 
products, however, it is taken out, and another, water-soluble 
form is added which they are unable to absorb.
    Mr. Burton. Pardon me, Dr. Megson.
    You heard all those buzzers. That means that I have to run 
to the floor and vote or else I will be voted out of office, 
which I do not want to happen.
    Dr. Megson. OK.
    Mr. Burton. So if you will please bear with me, I will get 
over there and vote and get back just as quickly as I possibly 
can, because I am very interested in everything that you folks 
are saying, and I do want to get answers to a number of 
questions.
    We have two votes, and I will be back just as quickly as 
possible, so we will stand in recess--there are how many 
votes--I think everybody had better get a cup of coffee, 
because there are four votes. It is probably going to be half 
an hour before I get back. I apologize.
    We stand in recess.
    [Recess.]
    Mr. Burton. I really want to apologize to those of you who 
have been so patient today hearing all the debate. It must have 
been difficult for you, but I am sure it has also been 
entertaining.
    Would you close the doors in the back after everyone comes 
in?
    OK. We left off with Dr. Megson in a very impassioned 
moment of her talk.
    Dr. Megson. Briefly, I was saying that in the vast majority 
of these children, I get a history from one parent or another 
of a disorder associated with a defect in these major 
signalling proteins, the G proteins.
    As I approached my research, I looked through the eyes of 
these children and tried to figure out what their world was 
like. Now that I have talked with them and know what questions 
to ask these children, I understand how these G protein defects 
affect their perception.
    They have a severe loss of rod function in their eyes. 
There are four beautiful studies that have been published and 
out there for several years that show this. They are then left 
with cone function in which to see their world. Cones give us 
color and shape in our environment. The only situations I could 
imagine having only color and shape to organize my world are 
those ``magic eye puzzles,'' where you look beyond and back up, 
and then you get a box of 3D. That is the only place in their 
visual field where they get a 3D impression of objects.
    Mr. Burton. Everything else is flat?
    Dr. Megson. Correct.
    Only then, when they look at a box, like television or a 
computer, or a therapist who is sitting right in front of them, 
do they consistently hear the right words for what they are 
looking at. So that most of the day, they are not hearing the 
right words for what they are looking at, because they only 
have one area of their visual field where they see 3D.
    I have treated some adults, and one adult I am treating in 
Alabama calls me every week and gives me the measurement of his 
``box'' as it grows, and he gets better, which is really fun.
    The other areas of perception and sensory perception are 
controlled by G protein pathways as well, and adding a second 
defect to these children, who on a genetic basis probably have 
a first defect, changes multiple sensations. Their avoidance of 
eye contact is an attempt to have light land off-center in the 
retina, where they have some rod function. So when they look 
away from Mom, they are actually looking at Mom. When we make 
them force their pupils directly in front of us, we are making 
them look away from us. With this form of natural Vitamin A 
treatment, within days, they look right at you.
    The other things that happen in these children--suddenly, 
Mom's touch starts to feel like sandpaper on their skin because 
of modulation of touch; common sounds sound like nails scraped 
on a blackboard. These are words that autistic children have 
given me as they have gotten better.
    We think these children cannot abstract, when actually, we 
are sinking them into the middle of an abstract painting at 18 
months of age, and they are left trying to figure out if the 
language they are hearing is connected to what they are looking 
at at the same time.
    This defect for congenital stationary night blindness is on 
the short arm of the X chromosome, which explains the male-to-
female ratio autism, and it affects cell membrane calcium 
channels that Dr. Goldberg just referred to in the hippocampus. 
These are the NMDA/glutamate receptors in the hippocampus. 
These pathways are where major pathways processing language 
cross from the left side of the brain to the right. The 
pathways then go back through the hippocampus. The frontal lobe 
is where attention is added, executive function, inhibition of 
impulse, and all social judgment.
    When stimulated, these NMDA receptors through their G 
proteins stimulate other receptors in the nucleus of the cell, 
right there at the hippocampus. These receptors were discovered 
by Ron Evans in December 1998. In the animal model, when they 
are blocked, the mice are unable to learn or to remember 
changes in their environment; they act like they have 
significant visual perceptual problems, and they have 
significant spatial learning deficits.
    Of great concern to me is that when the hepatitis B virus 
was initially isolated, the protein sequences were isolated and 
inserted into the gene for one of these Vitamin A receptors, 
RAR beta. This is the critical receptor important for 
plasticity and retinoid signaling in the hippocampus in this 
area of major pathway intersection. We will have to look at the 
vaccine and see if there is any defect being produced by that 
related to the recent increase in autistic spectrum disorders.
    What I am treating these children with is the natural, 
lipid-soluble form of Vitamin A. I am giving them their 
recommended daily allowance only of Vitamin A in the form of 
cod liver oil to bypass these blocked G protein pathways and 
turn on these central retinoid receptors.
    In a few days, a lot of these children look at me, focus, 
they regain eye contact, and they talk about their box of 
vision growing. After 2 months on this Vitamin A treatment, I 
give them a single dose of a medicine called bethanechol, which 
stimulates pathways in the parasympathetic system in the gut. 
What I have discovered is that there are nerve receptors in the 
gut called acetylcholine receptors, or muscarinic receptors 
which are blocked in these children. This medication mimics 
acetylcholine. It does not cross the blood-brain barrier. I 
give it to these children in the office, and sometimes, 30 to 
40 minutes after the initial dose, after having pathways 
corrected for several months of Vitamin A, when I bring them in 
and give them this medicine and observe them, they connect in 
the office. I have had children look at me, talk, act out, talk 
back to their mothers, and use vocabulary above their 
chronological age. This is a disconnect, and I have seen this 
again and again and again. Bill Walsh in Chicago has seen it; 
Woody McAinnis in Arizona has seen this change.
    In one child I have treated beginning last April, her IQ 
score has gone up 105 points, from 60 to 165.
    This treatment improves cognition, but these children are 
still really physically ill. Their Vitamin A stores are 
depleted, oftentimes before and if not before, at the time of 
the MMR vaccine, and they cannot compensate for these blocked 
pathways.
    Vitamin A has been called the anti-infective agent. It 
leaves them immunosuppressed when they are depleted. They lack 
cell-mediated immunity. Adding a second defect to this GI alpha 
protein blocks a very important pathway in the body where you 
convert retinol into something called 14-hydroxy retro-retinol. 
14-HRR is needed to turn on T-cells.
    I give these children cod liver oil--cold water fish oil is 
the only natural source of 14-HRR--and the children get well.
    The parasympathetic nervous system which is blocked in the 
gut is part of what I call the peripheral nervous system. We 
think of the nervous system as having two major parts. The 
central nervous system is the brain and spinal cord. The 
peripheral system is divided into two parts. The sympathetic 
nervous system is your fight-or-flight response--everything 
that happens to your body when you run away from danger--you 
dilate your pupils, increase your heart rate, and increase your 
blood pressure. The parasympathetic side of the peripheral 
nervous system allows us to sit back, relax, focus, and digest 
our food. We are blocking the parasympathetic side of the 
nervous system, and these children are in fright or flight all 
the time.
    I have asked someone to bring these panels out so you can 
look at these children and see their faces.
    I live in a small middle-class neighborhood with 23 houses. 
I recently counted 30 children who were on stimulants for 
attention deficit hyperactivity disorder. One week ago, my 
oldest son, who is gifted but dyslexic, had 12 neighborhood 
friends over for dinner. As I looked around the table, all of 
these children but one had dilated pupils. After 2\1/2\ months 
of taking his recommended daily allowance of Vitamin A and D in 
cod liver oil, my son announced: ``I can read now. The letters 
do not jump around the page anymore.'' He can focus, and his 
handwriting has improved dramatically.
    In a survey in his private high school for dyslexic 
students who are bright enough to go to college, 68 out of 70 
of those children reported night blindness. They see headlights 
like starbursts, and they get a whiteout when their picture is 
taken.
    I think we are staring a national disaster in the face 
which is affecting thousands of American children. The children 
with autism, ADD, dyslexia are lucky in a way, because they are 
identified. There are many other children out there who are not 
identified and who have just been disconnected.
    We must direct all of our resources and efforts to 
establish multidisciplinary centers to treat these children. 
Insurance companies should pay for evaluations, both medical 
and psychiatric, and treatment.
    For over a year, I have been paying for speech therapy for 
these children. They are able to talk, but they do not know 
what to do with their mouths. I have had 10-year-olds wake up 
and talk. Insurance companies do not pay for rehabilitative 
services for these children. These children are physically ill, 
immunosuppressed, have a chronic autoimmune disorder affecting 
multiple organ systems. We must get funding to look at the 
etiology of autism and identify these children prior to 
autistic regression and prevent this disorder. Implementing 
vaccine policies which are safe for all children should be our 
first priority.
    Mothers from all over the country have brought pictures of 
their autistic children to Washington this weekend. Most of 
these children were born normal and lost to ``autistic 
regression.'' Look into their eyes, and you will hear their 
silence.
    Mr. Burton. Thank you very much. We are going to read the 
text of your comments very thoroughly.
    Dr. Megson. Thanks.
    Mr. Burton. Dr. Upledger.
    [The prepared statement of Dr. Megson follows:]
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    Dr. Upledger. Thank you.
    I am John Upledger. I am an osteopathic physician, and I 
thank you for inviting me to come and present today.
    I should probably tell you a little bit about my background 
first, because you will understand that I am coming at autism 
not in disagreement with anyone but by adding another parameter 
to it.
    First of all, I used to teach biochemistry, so the 
molecular things are not new to me. I practiced general 
medicine and surgery for about 11 years in Clearwater, FL and 
then got into the rather avant garde things, and they invited 
me up to Michigan State University, where I became a clinician 
researcher in the Department of Biomechanics.
    Being a researcher in biomechanics, I was researching a 
system which ultimately became called the craniosacral system. 
The craniosacral system is simply a semi-closed hydraulic 
system. The boundary of the hydraulic system is the dural 
membrane which encases the brain and spinal cord and provides 
sleeves for all of the cranial nerves and for the spinal nerve 
roots. The fluid inside it is cerebrospinal fluid, essentially. 
Of course, there is blood flowing and so on and so forth within 
vasculature, but it is not really part of the system. And it is 
called ``semi-closed'' because the inflow of the volume is 
controlled, and it is rhythmical, and the outflow is rather 
constant and reabsorbs the fluid; so you have a circulation of 
fluid with a rhythmical rise and fall of fluid volume and 
pressure within the system.
    If one looks at advances as we go along, we used to think 
that cerebrospinal fluid bathed the surface of the brain, and 
that is what it did. About 8 years ago, it was very definitely 
shown using radioactive tracers that cerebrospinal fluid is 
formed in the ventricles of the brain, and within seconds of 
its formation, it not only bathes the surface but it penetrates 
all the spaces between all the cells that form the brain; it 
also goes down the spinal cord internally as well as 
externally.
    More recently, in a symposium called ``Neuroprotective 
Agents'' by the New York Academy of Science, I came across a 
piece that had just been discovered, that is, that 
cerebrospinal fluid not only circulates nutrients and carries 
away waste products, but it also has chelating agents in it, so 
it cleanses the brain of metallic deposits, which would be the 
mercury, the aluminum and that kind of thing.
    So it is very important, and if you look at it this way, it 
is extremely important, that cerebrospinal fluid flow be kept 
moving. Stagnation of cerebrospinal fluid is going to lead to 
brain dysfunction.
    In my work at Michigan State in developing this department, 
developing this whole system, what happened was that it was 
decided that I would be working with brain-dysfunctioning 
children to see the applications. Autism happened to be one of 
the things that I was assigned to, so for 3 years, I spent 2 
days a week at the Genessee County Center for Autism, and I 
went in there not even understanding the first thing about what 
autism was.
    We did work with what was called hyperkinesis in those 
days, and we found out on a structural level that the 
hyperkinetic child could be relieved of his hyperkinetic 
activity if we released a compression at the base of his skull 
between the first cervical vertebra and the occiputal base. 
Tracing this backward, this happens a lot during delivery. The 
baby is face down, the obstetrician assists the baby coming out 
under the pubic bone, the head comes base or forward, and the 
cervical vertebra goes that way, and they jam together. You 
release that jamming, and you get rid of your hyperkinesis in a 
matter of minutes many times.
    That is not the only cause for hyperkinesis, but when it is 
there, and you release it, it is very definitely going to show 
you clinically that it is over.
    We also found out that in newborns we could treat colic 
this way.
    When I got into looking at autistic behaviors, there were 
several things that we noticed, and being a novice, I was not 
about to accept anybody's word for anything. I went over there 
with a neurophysiologist and another fellow who was a 
generalist in science, a design specialist, and we started 
going every week, Thursday and Friday.
    Our observations showed first of all that a lot of the kids 
were banging their heads. There were 28 kids in that first year 
we went there. I noticed their head-banging, and they were 
chewing on their wrists; they would get all the way down to the 
tendons sometimes. We were also told they sucked on their 
thumbs, and I saw that, but they were not making an airtight 
things with their lips; what they were really doing was pushing 
up on the base of their skulls.
    So we thought about this a lot, and one would say, OK, they 
are banging their heads, and this happened at a behavior 
modification center that we were working at, so I had them take 
the helmets off, and we let them bang their heads and watched 
very carefully, and it looked like they were trying to knock 
something loose in their heads, as if something was jammed 
together.
    When we started looking at their wrists and everything, I 
thought, OK, maybe they are inducing a controlled pain for a 
pain they have in their head that is uncontrolled, because I 
think anybody here would agree that sometimes when something 
hurts, and you just cannot get to it, you will give yourself a 
pain somewhere else, and it at least gives you some sense of 
comfort. And the other thing that might be happening is when 
they are chewing, they are inducing endorphin production and 
getting that natural analgesia, because endorphins are like a 
natural morphine.
    The thumb-sucking clearly, to the point where it was 
causing the teeth to protrude forward over a period of time, 
the thumb-sucking clearly was an attempt to mobilize the base 
of their skull.
    Anatomically--and now I am in biomechanics, so I am 
thinking anatomically, and what I am doing a lot of on the 
other days off is getting very fresh cadavers, dissecting them, 
studying membranes and all of that kind of thing on the inside 
of the head, so I am tying these two things together. So we 
began to get the idea that the cranial rhythm or the movement 
inside that head was not giving the amplitude that we were 
looking for in other children. The autistic head just did not 
have the craniosacral rhythm, the activity, so it was not 
pumping cerebrospinal fluid.
    Hence, you would get an accumulation of toxic metals. You 
would also get a deficit in the delivery of fluid carrying 
nutritional agents and carrying away metabolic byproducts. You 
would also get a thing that we began to understand clearly, and 
this became the model we put forth after about the second year, 
and that is that something occurred to denature the membrane 
biochemically so that it would not expand and accommodate the 
normal growth pattern of the skull as it was trying to expand 
in the brain and trying to grow. If the brain is trying to grow 
against the resistance of a membrane that is having difficulty 
expanding, you are going to cut down cerebrospinal fluid 
exchange and you are going to cut down blood flow.
    We finally got into it and started decompressing heads 
forward to backward in this direction--forehead forward, back 
of the head backward. We would just sit there and hold it, a 
small force over a long period of time, and ultimately, the 
head would begin to expand in that direction. When it did, 
those things that looked like they were trying to create their 
own pain--the thumb-sucking stopped, the head-banging stopped, 
and the wrist-chewing and that kind of thing stopped--they 
stopped spontaneously after we released that particular 
forward-to-backward compression.
    That was probably very close to 100 percent response. Now, 
you had to spend a lot of time to get an autistic kid to lie on 
a table in an autistic center and let you work on them and have 
them be quiet, but after we saw them three or four times, they 
would actually come in, lie down on the table, take your hands 
and place them on their head where they wanted them. And I 
would go along with that.
    The next thing I wanted to do was expand the head side-to-
side. I had a lot of graduate students with me all the time and 
did not know what to do with them, so I would put one student 
on each leg and one student on each arm, and I would just start 
expanding the head laterally. Well, we found out that after we 
got that expansion done laterally, first of all, the child 
would very, very much relax, and the body would go into all 
kinds of contorted positions and stay there. As they stayed in 
that contorted position, you could feel energetic changes going 
on throughout their body, and when they finished that 
particular thing, they were very liable to turn around and kiss 
you and give you a hug. And after that, they became sociable.
    So what I am looking at is a model here that says, OK, 
decompress these membranes. What caused the membranes not to 
expand? And then, historically, we started looking at it. 
Febrile episodes were extremely common. The fever could be due 
to a vaccine reaction, it could be due to a viral infection, it 
could be something in utero that occurred when Mom had a little 
fever when she was still pregnant. And it seemed as though it 
was taking about 2 to 3 weeks historically for most parents to 
discover the signs of the changes occurring which were later 
called ``autism''--after the febrile episode.
    So we chalked up the idea that most likely febrile episodes 
could cause a change in the biochemistry of the membrane so 
that it did not accommodate the growth process as readily as it 
could. Now, that does not fly in the face of genes at all, 
because I am sure that genes control some of the accommodative 
process of the dural membrane, and therefore, if they have a 
genetic predisposition to a membrane that is vulnerable, it 
takes a smaller shock to make the membrane become less 
accommodative. That does not bother me at all.
    We also found--after I got this going, I was invited to 
London to start an autistic treatment program for children in a 
craniosacral therapy clinic, and again, in Brussels. And in 
London, I have to tell you that I wound up evaluating children 
that I thought were autistic from a craniosacral evaluation 
perspective--I wound up with 42 children in that clinic, and I 
was there for about 4 days evaluating them--and 38 of the 
parents out of the 42 said the febrile episodes were subsequent 
to a vaccine. And most incriminating--and this would be in the 
late seventies--the vaccine most incriminated by the parents in 
their opinion was pertussis.
    When I went to Brussels, it was an entirely different 
thing. The feel of the head, the energy patterns in the head, 
everything was different. Almost all of the autistic kids I 
picked up there had been delivered by vacuum extraction--that 
is where they put the suction cup on the head and just pull. If 
you consider a plumber's tool, and you clamp it on the top of 
the head and pull, what you are going to do is extravasate a 
lot of capillary blood, and when blood breaks down and 
deteriorates, it becomes bile in one of its stages, which is 
extremely irritating, so the tissue that has these red blood 
cells that are deteriorating begins to contract and cause 
scarring and lose its accommodative ability. In Belgium, that 
was the main cause we came across.
    In this country, there is a great variation. At the 
autistic center where I spent the first 3 years of my 
experience, I would have to say that two-thirds of those kids 
were in foster homes, so we did not know much about their 
backgrounds. But when I finished the contract for autism at the 
Genessee County Center in Flint, we opened a clinic at the 
university, and there, I have to say that probably 50 percent 
of the parents were totally convinced that the autism was 
secondary to a febrile episode which more often than not, they 
related to a vaccine reaction. And I do not say that that is 
yes or no, but I say it certainly does deserve a healthy look.
    Some of the things that I would like to share with you that 
we did--and it is interesting that Dr. Megson talked about 
parasympathetic, because one of the pieces of research we did 
on our autistic children was to monitor with a thermograph the 
hand as we were stretching the membranes in the head. And as we 
got some releases, the temperature of the hand would go up 2 or 
3 degrees Fahrenheit, which indicates that the blood vessels in 
the hand are relaxing; you are getting better blood flow. And 
in order to get better blood flow, you have to reduce the 
activity level of the sympathetic nervous system which she was 
referring to, and that is the flight-or-fight system.
    So we were able to reduce their sympathetic activity by 
working on their head and stretching their membranes.
    Now, the whole thing begins to make a lot of sense if you 
consider, then, the things that we were watching happen. If we 
got a child's membrane stretched in all directions, and he was 
feeling pretty good, he would take on a lot of good behaviors; 
and if we got that to happen and then--our research was always 
held up from June until September when school was out, getting 
the contract renewed and all that kind of thing, so we had a 
lot of children who did not receive treatment for 2 or 3 
months, and they would regress. I look at it this way--their 
head is trying to grow, and their brain is trying to grow, but 
they need a mechanical stretching activity which is 
craniosacral work to keep the membrane spreading enough so that 
it will accommodate that intended growth process. And if you do 
not have that for a while, then you begin to regress because 
the pressure on the brain and the reduction of fluid activity, 
the reduction of blood flow, all begin to recur.
    So the next thing we try to do--and we have done this 
successfully I would say with 30 percent or so of our parent 
groups, and I did not have the opportunity to do it the way I 
would really like to--but we taught them to do this treatment 
process once a week and maybe see a therapist every 6 weeks or 
so. That seemed to work if the parents were willing and able to 
learn how to do it. It is not hard once you get the initial job 
done; then it is a question of maintenance, which is not too 
difficult. And that is one of the things we look for.
    I left the university in 1983 and took time out to develop 
a prototype for a holistic health center for Unity Churches, 
and then we started our own institute in 1985, at the end of 
1985. Since that time, the way we handle the problems is, first 
of all, we do not always focus on autism, because the kind of 
difficulties we have with the craniosacral system can involve 
anything from autism to hyperkinesis to chronic pain--seizure 
activity is a big one we work with--and all those kinds of 
things, but about four times a year, we will have a special 
intensive program for just autistic children. That is what we 
do, and we try to help the parents learn how to work with it. 
And when I say ``intensive,'' it is a week, and it is from 10 
a.m., until 6 p.m., and it is hands-on work almost all the 
time. During that week, we get things pretty well taken care 
of. And I do not think we have had a child yet who did not show 
at least 50 percent improvement during that period of time, and 
most of them do significantly better than that.
    That is about where I am.
    Mr. Burton. Very good. That was a very good lecture. I 
enjoyed that, and we will have some questions about whether or 
not any of our health agencies have picked up on your 
procedures.
    Dr. Upledger. Thank you.
    Mr. Burton. Dr. Pratt.
    [The prepared statement of Dr. Upledger follows:]
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    Ms. Pratt. Mr. Chairman, thank you for the opportunity to 
present testimony today concerning autism treatment options and 
research. I am here today kind of in multiple roles, first as 
director of the Indiana Resource Center for Autism, located at 
Indiana University's Indiana Institute on Disability and 
Community, and as a board member of the Autism Society of 
America.
    I would like to commend you and thank you for holding this 
hearing. I think that for too many years, the voices of some of 
the children you see on the posters have not been heard; this 
gives them a wonderful opportunity to be heard.
    While I have your attention, I would encourage you to do 
two things. One is to continue funding the Centers for Disease 
Prevention and Control in terms of looking at the incidence and 
prevalence of autism. As I was working with your office on 
providing testimony for today, it is clear that we do not have 
a true idea of the incidence and prevalence of autism across 
the United States.
    The other thing that I would encourage you to do is to work 
with your colleagues on supporting H.R. 3301, which is the 
omnibus children's health bill, which would provide clear 
direction to the CDC and the National Institutes of Health.
    I am probably the oddity on this panel. I am not a 
physician. I spend a lot of time in classrooms and in homes and 
around the State of Indiana, visiting children and their 
families and their educators and other professionals who 
support them. And while I know that there is broad disagreement 
about whether there really is an increasing incidence of 
autism, I know that we are incredibly busy. I know that I hear 
from professionals out in the field and from family members 
that they truly are seeing many more children than they ever 
saw in the past. So I have to listen to their words.
    In terms of the potential causes of autism, I hope you 
realize that autism is referred to as a ``spectrum disorder,'' 
and along with that, that probably reflects the idea that there 
is a spectrum of reasons why children do develop the 
characteristics associated with autism and that each of the 
professionals and family members who are here today are 
painting just a piece of that picture for you. I would really 
encourage you to propose legislation and funding that will look 
at the possible multiple causes of autism, and along with the 
vaccination issue, the issues around environmental situations 
and other issues which parents keep reporting as being possibly 
related to the occurrence of autism.
    I have never heard from any of the families an issue about 
whether they want to vaccinate their children or not. I think 
the issue is in terms of safe vaccinations. As a professional 
in the State of Indiana, I know there is broad disagreement 
about whether there is a link between autism and vaccinations.
    As a professional who works with families every day, here 
is my position. If I could have helped those four families who 
are here today to avoid having a child diagnosed with autism by 
giving them accurate information, I would have done so in a 
heartbeat regardless of what the research tells us. I think 
that is the issue that all of us face, that when the research 
may not be proving it, when we hear the stories, we want to 
avoid further stories being told.
    In addition to looking at the research behind causes, I 
would also encourage us not to forget about the 500,000 other 
individuals and their families who currently have a diagnosis 
of autism and the needs that they have. The families and 
several of the panelists today have talked about some of those 
needs.
    The first one is in terms of early intervention. I really 
applaud the National Academy of Sciences and the National 
Institutes of Health for starting to look at the essential 
components of early intervention programs that are most 
effective. I think we have focused a lot of effort on looking 
at specific programs, and while there is some broad 
disagreement about which of those specific programs is most 
effective, I think there is some general agreement arising 
about the components of those programs, and I hope that those 
things will really be looked at.
    Based on the testimony that I have heard during the 
National Academy of Sciences meetings, it is very clear that 
additional research is needed to try to really build a case for 
the various components of effective programming.
    The next issue that I would like to cover is full funding 
for IDEA and the professional development efforts. In a recent 
report, it was noted that 44 out of 50 States are not in 
compliance with the ``free and appropriate education'' mandate 
of the Individuals with Disabilities Education Act. While those 
reasons may differ from State to State, I believe part of the 
reason is due to funding.
    In addition to that, there is a tremendous need for trained 
professionals in the field. Sometimes, professionals are placed 
in the role of supporting challenging individuals, and they do 
not receive any training or guidance or assistance in being 
able to do so. So I would really encourage that we look at 
providing funding support to States for continued professional 
development.
    In addition to that, you have heard from many of the 
parents about the need for accurate information to 
pediatricians and other physicians who play a critical role. 
They are oftentimes the first people that parents talk to when 
they think their children may have a diagnosis of autism. The 
information that they can provide to families can help to set 
them on either the right track or the wrong track. So I really 
encourage education for them.
    Another issue that I hear a lot from families is in terms 
of insurance coverage and funding sources. In my written 
testimony, I provide the example of a family in Indiana that 
was denied coverage for their child's appendectomy because he 
had a diagnosis of autism. Autism is considered a pre-existing 
condition by some insurance companies, so these children are 
excluded from insurance coverage.
    I hope you realize the tremendous accommodations that the 
families that you saw today have had to make to be here today, 
and in their lives on a daily basis. The tremendous financial 
devastation that many of them face, the stresses on their 
marriages--and I am so glad to see that many of them are here, 
fathers and mothers together--the stress on their entire lives 
is just unbelievable. You know first-hand as a grandparent how 
tremendous the stress can be.
    I also need to tell you that your support is greatly 
appreciated by the autism community. Your support is even more 
greatly appreciated by your daughter today.
    I also hope you realize that when insurance companies turn 
families away, they look to other funding sources, whether 
State or local agencies, and in many cases, that money, that 
funding, is nonexistent or is inadequate for the family support 
needs. Families are told that they have a window of opportunity 
for their children, and at that point, they have run to get 
those services and supports that they need; and when they are 
denied the funding they need to be able to provide those 
services, they will do anything and risk tremendous devastation 
to be able to reach those goals.
    A population that I hope we will not forget is the adults 
who have autism. We have a high percentage of individuals who 
remain unemployed, who are very competent, talented individuals 
with autism; others who are underemployed or in jobs which 
really do not match their talents and skills and interests.
    In addition, many of them choose living options that are 
only a far-off dream--to live in a community, to have access to 
the same rights and privileges as every other citizen of the 
United States. While progress has been made in this area, much 
is still left to do.
    While I commend the committee for taking this opportunity 
to listen to families today, I also urge you to support 
authorizing legislation and appropriation provisions that will 
further the state of autism research. While much progress has 
been made, remember that there is still much to do.
    Thank you.
    Mr. Burton. Thank you very much, Dr. Pratt.
    Dr. Hirtz.
    [The prepared statement of Ms. Pratt follows:]
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    Dr. Hirtz. Mr. Chairman, I am Deborah Hirtz of the National 
Institute of Neurological Disorders and Stroke [NINDS], at the 
National Institutes of Health.
    I have been asked to appear before you today to give the 
committee and the families of autistic individuals who are here 
a sense of what we have learned from research, what we hope to 
achieve, and I want to explain that we at the NIH share the 
sense of urgency that autistic individuals and their families 
and advocates feel with regard to unlocking the mysteries of 
this devastating disorder.
    As a physician who takes care of children with neurological 
disorders including autism, this urgency has a particular 
intensity for me as well. By presenting information about a 
broad array of NIH autism research activities, I will try to 
convey to you the strong commitment of the NIH to increasing 
our knowledge about autism, what causes it, how best to 
diagnose and treat it, and we hope not too far in the future, 
perhaps even how to prevent it.
    I would also like to tell you that over the last 5 years, 
the total NIH funding for autism research has nearly 
quadrupled. It was $10.5 million in fiscal year 1995 and $40 
million in fiscal year 1999.
    We now know that autism is much more common than we 
previously thought. Estimates vary widely, but recent studies 
suggest that as many as 1 in 500 people may be affected by some 
form of autism. Recent reports suggest that the number of 
children with autism may be increasing substantially. It is not 
clear whether the reported increases can be accounted for by 
improved or expanded diagnosis, or by the increasing 
availability of services for autism and it would be necessary 
to study the trends of that prevalence over time.
    The NIH recognizes the pressing need to look into these 
issues and to do this work and is actively working to design 
studies that can give us knowledge in these areas. Accurate and 
consistent diagnosis of autism is one of these difficult areas. 
To address this problem and in response to the requests of 
concerned parents, the NIH sponsored a 1998 meeting of major 
medical and professional societies, parent advocacy groups and 
Federal agencies to review existing evidence for autism 
screening and diagnosis. Based on the assembled research and 
evidence, a consensus statement is near completion as a 
practice parameter, which is a professional guideline for 
recommended procedures, criteria and timing for screening and 
diagnosis in autism. This will be the first time that such a 
multidisciplinary group has reached consensus on screening and 
diagnostic procedures in the area of autism. The specific 
practice parameters or clinical recommendations, once approved, 
which we expect to be shortly, by the boards of various 
relevant professional societies, will be published in widely 
read medical journals.
    In the vast majority of cases, no specific underlying cause 
of autism can be identified. A variety of genetic, metabolic, 
infectious and unknown factors may be important. The NIH 
supports research directed at exploring the possible role of 
these various factors and is exploring the feasibility of a 
very large, multi-agency, prospective study that could shed 
light on some of these questions.
    A working group convened by NIH in 1995 reached a consensus 
that for at least a significant subgroup of people with autism, 
there appears to be a genetic susceptibility that most likely 
involves multiple genes, and the NIH has conducted two major 
meetings on the genetics of autism.
    An exciting development this past year has been the 
identification of the gene for Rett syndrome, an autism 
spectrum disorder. In addition, genetic ``hot spots,'' 
potential chromosomal locations, for more classic forms of 
autism have been identified. In another area, NIH is supporting 
a major pediatric brain imaging initiative to learn how the 
brain develops in normal infants, children and adolescents. 
This will provide important data for comparison in studies of 
developmental disorders such as autism.
    Although there is currently no known cure or treatment 
which can reverse all the symptoms of autism, interventions 
designed to alleviate specific symptoms are available. In 
November 1999, the NIH held a workshop in conjunction with the 
Department of Education on treatments for people with autism 
and other pervasive developmental disorders. The purpose of 
this workshop was to evaluate the current biological, 
behavioral, psychopharmacological and biomedical treatments in 
autism and to identify critical research needs in autism 
treatment. The written reports and recommendations from the 
working groups at this meeting have recently been assembled and 
are currently being reviewed by the members of the NIH Autism 
Coordinating Committee, which is a group from various 
institutes involved that coordinates the NIH research 
activities, and also by the representatives of autism advocacy 
groups to see where we go from here in pursuing various avenues 
of treatment research.
    I have just very briefly described some of the NIH autism 
research activities. There are several more presented in my 
written testimony.
    I would like to add that autism research is a major 
priority for the NIH, and we are committed to continuing to 
work to expand our efforts.
    I have tried to stick as closely as I could to the 5-minute 
limit, Mr. Chairman, so that concludes my prepared statement, 
but I would be pleased to respond to any questions you might 
have.
    Mr. Burton. And your full statement will appear in the 
record.
    Dr. Cook.
    [The prepared statement of Dr. Hirtz follows:]
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    Dr. Cook. Thank you, Mr. Chairman, for the opportunity to 
testify on the topic of autism. I am, as some have before, 
speaking as someone wearing three hats--actually, first, as the 
brother of the late Kenneth Wade Cook, who had many of the 
problems of children and adults with autism; I am also speaking 
as a child and adolescent psychiatrist who cares for many 
patients with autism, and as a biomedical researcher trying to 
increase our knowledge of the causes of autism and, above all, 
to try to increase our ability to treat this devastating 
disorder.
    It starts with me recalling being an 8-year-old boy with a 
2-year-old brother who my family had just realized was not 
developing normally. I remember vividly the pain of my parents. 
I further recall that we went to a meeting where, to my 
recollection--I will not speak for my parents--we were told 
that it was known from theory about what was known of the brain 
at that point that ``patterning,'' a way of moving the arms and 
legs, a special diet, re-breathing through a mask, and related 
methods still practiced today in various forms, would cure his 
problems.
    I remember our family being skeptical from the beginning of 
that meeting. However, by the end of the meeting, we and the 
other families in the group were sold on this treatment because 
it was too painful to accept what we knew was happening.
    If there is anything I have not forgotten, it is that hope 
is something essential in working with children with severe 
challenges--for the children, for the families, and for all of 
us.
    I am very thankful to those who were interested enough that 
far back in children with developmental problems to have spent 
so much time with my brother and my family and to be with us. 
They knew that providing us the tools to work to teach my 
brother the basics of communication and motor skills was very 
helpful, and I suspect that many of them were practicing this 
method for the same reason we were--they simply had to try.
    I could complain about the 5 a.m. mornings in which as a 
child, it was physically exhausting to perform the patterning, 
but I am sure it was good training for being a physician-
scientist, or perhaps a Congressperson.
    However, I am not pleased that there was not more time 
spent teaching me to play with my brother instead of trying to 
teach him to read just to show that their method was working, 
when it was not even close to being an appropriate next step.
    Our family learned to accept and love my brother deeply. I 
would like to add that at this time, the preferred professional 
response was to tell you to put your child away at birth. And 
some of our increased awareness, I am afraid, actually 
positively, is that we do not simply ship the kids away. We 
felt sort of like we were going against advice to keep him in 
our home, which we did for 10 years.
    I am very thankful that children today have more 
opportunities for education due to congressional legislation. 
Excellent community support and model community support in St. 
Louis was vital to my family during my brother's last year. 
Mostly, I miss him deeply, since his death remains as 
unexplained as his original problem, although the two are 
certainly related. It reminds me that not only is there much 
suffering, there is also death with this disorder.
    Obviously, I am also a physician-scientist because I cannot 
accept this, even after he is gone. Having several hats, as 
brother, physician and scientist can be extremely painful. I 
recall my anger as a child when investigators found that 
patterning was not effective. As it turns out, I collaborate 
with people at the same institution at Yale today--but I 
wondered how could they do such a thing, and how could I now be 
in their shoes, now that I have studied secretin and have 
failed to find that it is working as much as initially claimed.
    The only thing in my defense, frankly, fighting myself 
here, is to say that I actually shed a tear when the data were 
analyzed for secretin, because even though at the bottom of it, 
there is not a lot of plausibility, I do not care--I deeply 
wanted this to work. And that is probably what my anger is, 
that all these things have not provided what they say they 
will, and I am the first one who wants them to work.
    So our laboratory, not being satisfied with the status quo, 
has worked on neurochemistry, neuroendocrinology, neuroimaging 
and neurogenetics of autism. The reason for our current focus 
on genetics is the data, not our impressions or our wishes, 
show it to be the most powerful influence on the etiology of 
autism--and many have been studied carefully--maybe not 
carefully enough.
    It is not the only influence--I would agree with what has 
been said several times--it is certainly not the only influence 
in autism, and it is certainly not a simple, single-gene 
disorder. If it were, we would know for sure what that single 
gene was.
    However--and this is very important--it is a rare event in 
my lifetime to realize that suddenly, molecular-genetic study 
of autism spectrum disorders provides one of the best 
scientific opportunities in medicine. I must say that usually 
throughout my career, I have had my passion, and my colleagues 
say, yes, it is very important, but there is no scientific 
opportunity; we cannot learn anything there. In genetics, we 
are actually ahead of most other medical disorders when we 
study autism.
    In terms of why study genetics of autism, I think it is 
unlikely--and I would have said this before recent events--that 
gene therapy will be the result of genetic research in autism. 
It is also unlikely that genetics of autism will explain a 
relatively recent increase in measured autism prevalence.
    The point of genetic research is to develop treatments that 
will correct the missing or abnormal signals for a small set of 
nerve cells in the amygdala, hippocampus and cerebellum so that 
the nerve cells mature. I very much agree with those who are 
optimistic on this point. These are not children who have 
brains that cannot further develop. That is my view, but it is 
a view as a scientist. You do not see the kinds of changes in 
the brain that would make things not able to move forward.
    If we knew the signals, what has long been a too 
complicated puzzle of autism would become simple enough for us 
to understand. We are all challenged in a sense in trying to 
make sense of this. So although the simple idea is to provide 
gene therapy, oral delivery of more traditional small 
molecules, which we usually refer to as ``medications,'' is 
likely to be more feasible and preferable, partly because there 
are few treatments that we have not wanted to take back. That 
is certainly something that I have learned as a physician--I 
try things, and they make sense, but if they do not work, it is 
time to stop them.
    Two recent developments in the broader field of 
developmental disorders show that complex situation may be 
better understood through molecular genetics. The first is the 
finding of the gene for FRAXA, or Fragile XA mental 
retardation. This is very relevant to autism since a 
substantial proportion of children with FRAXA have autism 
spectrum disorders. Although one wishes knowledge of a gene 
will lead to new treatment sooner, the results of a decade of 
research in FRAXA to understand the mechanism of this disorder 
is leading to an almost exponential growth in understanding 
complex interactions of molecules in the process of learning.
    Mentioned earlier, which is actually quite historic, was 
the recent finding of the gene for Rett syndrome, because this 
is actually finding a specific gene for an autism spectrum 
disorder. It is notable that it is caused by a single gene, 
MECP2, but that it has a course of regression in social 
behavior and communication between the first and second 
birthdays. Knowing the gene has led to a breakthrough in the 
systematic approach to investigation of Rett syndrome in terms 
of how it affects the development of the brain, and this is 
already moving us forward.
    Although we do not know the specific genes involved--and I 
would agree with that, and it is definitely something that is 
personally frustrating today--several groups have been finding 
evidence that an extra part of chromosome 15 leads to a high 
risk for autism, especially if inherited from the mother. 
Believe me, based on the history of autism, if I could have it 
come out another way, I would; but this is simply the origin of 
the chromosome and has nothing to do with the mother's 
behavior, as the theory went in the past.
    Although this is responsible for less than 4 percent of 
cases of autism, these 15q11-q13 duplications, like Rett 
syndrome and FRAXA, are helping us understand autism with 
regression, because all three of these often have this as a 
component, more generally.
    Several laboratories including our own are searching for a 
gene in this region. As an example of our concern in genetics 
about not wanting to waste precious resources, the probability 
at this point of there not being a gene in this region is about 
5 in 100,000 with the most rigorous blinded studies. But we are 
not sure yet, and that is just the way it has to be, because we 
may expend our resources in the wrong direction. We are close 
to sure at that level.
    Of course, the problem is that we will have to get beyond 
regions with likely autism genes to actually finding the 
specific changes and then getting on with the work of using the 
information to improve treatment, because that is the point.
    So it is a good thing there are people doing excellent 
clinical research and trying to improve educational and other 
interventions while we are working out the fundamental causes, 
with many others. However, it is important not to think we have 
more of an effect than we can back with controlled data.
    The history of autism teaches that zeal without skepticism 
may have negative consequences. The first was blaming mothers, 
and the second was false accusation of fathers of children with 
autism of abuse when their children were undergoing facilitated 
communication. That was probably the biggest problem that we 
had last decade in terms of things that, on their face, should 
not have bad consequences but did.
    The challenges of autism research are obvious. In terms of 
needs, I mostly want to thank Congress for the appropriation of 
increased funds for biomedical research generally. All of the 
pertinent NIH institutes are now actively engaged in the 
support of autism research.
    A simple statement of needs is that there are many 
important and feasible questions about autism not able to be 
asked with current resources. There are not enough well-trained 
researchers in the field, partly because, in spite of the 
figures that they have increased, I question that it was much 
more than zero 5 years ago. Most importantly, questions that 
are being asked efficiently, such as in the area of molecular 
genetics and others, are not being answered at an optimal rate 
given current funding in this area. That is not OK for me, 
because my patients are aging with me, and more are being born. 
Again, I am not criticizing the funding but appointing a 
statement of scientific opportunity that we do not want to 
miss.
    I thank you for the opportunity to communicate.
    [The prepared statement of Dr. Cook, Jr., follows:]
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    Mr. Burton. Thank you, Dr. Cook.
    Let me start the question with you. Do you subscribe to the 
theory that part of the problems of kids getting autism is 
caused by the vaccine?
    Dr. Cook. I guess that is a direct question to me, having 
evaded that.
    Mr. Burton. Yes.
    Dr. Cook. I have heard more today than I knew before I 
came. I did not specifically address that because I have not 
directly studied the question.
    As I see the data at this point, the data do not support 
the idea that vaccines cause autism. As someone who studied 
secretin as an example, I realize that I cannot prove the 
absence of something. For example, on secretin, all I can say 
is that I have proved the absence of it for myself; if someone 
else wants to come and only treat a certain kind of child in a 
certain kind of setting, then perhaps our work will have helped 
them.
    Mr. Burton. What would you think, Doctor, of taking a hard 
look at the conclusions that Dr. Wakefield and Professor 
O'Leary and Dr. Singh came to with their research? I know you 
work on genetics, but what would you think about looking at 
their research?
    Dr. Cook. Well, in some ways, I work in the area of 
clinical trials, so I can comment on why they fail to convince 
me that there is a connection. They have raised the possibility 
of a connection, but there are several areas in their logic 
that do not come together. It may be that if they were up here, 
they would say, yes, those are gaps that we have to fill--but I 
am concerned that in the presentations, starting with the 
original paper and today, they have not sufficiently 
highlighted where the gaps are, so the logic falls apart in a 
few places.
    First of all, if we know that we have prevented a lot of 
autism by preventing rubella-caused autism, which was a 
prevalent cause 20 or 30 years ago, as Dr. Chess showed, then 
why is it now MMR, and all of a sudden, it is measles?
    Now, if someone is so pleased--and I must say it is fairly 
fancy methodology in terms of pulling the measles virus out--
why not show that they can pull the measles virus out from the 
vaccine, differentiated genetically from the measles virus that 
would occur without the vaccine?
    These are holes, and my main thing is what I hear from the 
positive side is an almost total lack of self-criticism, OK? 
That is a key point----
    Mr. Burton. But----
    Dr. Cook [continuing]. That is a key point of the 
scientific method.
    Mr. Burton. But you do not think that their research is 
worth taking a look at?
    Dr. Cook. Oh, I think their research is very interesting, 
and I think it is particularly interesting to what I think--and 
this is an interesting epidemiological question--if there is 
autistic enterocolitis--and I think they have interesting 
data--how much of the total group of autism is it? From what I 
have seen, it would not be nearly enough of autism to account 
for an increase in prevalence.
    Mr. Burton. You heard the--and I am going to go down the 
line with the rest of you in just a minute----
    Dr. Cook. If I have a child who is vomiting, I very much 
agree with the----
    Mr. Burton [continuing]. You heard the testimony of the 
four parents as well as the testimony I gave about our 
grandson; and within just a day of their getting these shots, 
their temperatures went up, and they started the violent 
reactions, and it got worse. How would you account for that? Is 
that just a coincidence, or what?
    Dr. Cook. Well, if I am to take that as a reason for their 
autism to be caused, then I will agree with the parents who 
told me their child had autism because they took a 2-day trip, 
leaving the child with very good grandparents; they came back, 
and the child had autism suddenly. Am I supposed to now tell 
them, yes, you are right, because you see the connection--
because of a potential coincidence--you are right and caused it 
by taking 2 days off and leaving your child in very loving 
hands?
    I think we have got to be very careful and use careful 
epidemiological approaches. Dr. Taylor has done the best 
epidemiological study. There is not another one on the other 
side. If there were, I would weight it--in fact, I would give 
more weight to a positive, well-done epidemiological study. We 
have only got one.
    Mr. Burton. Well, I am not a doctor, but it just seems to 
me that the scientific community ought to have their minds open 
to all possibilities as far as the causes of autism are 
concerned. From your testimony, you sounded like it is a gene 
problem, and the vaccines could not possibly be a contributing 
factor.
    Dr. Cook. No. They could, but the people who think they 
could, the people who want to raise the hypothesis--and I am 
someone who has spent a lot of effort testing other people's 
hypotheses--I think there is a lot of duty when people raise a 
hypothesis, including Dr. Wakefield, from GI studies, who raise 
an epidemiological hypothesis, I think it is his responsibility 
to test the hypothesis carefully. I have thrown out hypotheses 
that I quite loved, and they were great--they were not all 
genetic; some were immunological--but you have to go with the 
data. If I have the data, I will go with it.
    Mr. Burton. When you studied secretin, did you study more 
than one dose?
    Dr. Cook. No. As a matter of fact, before we did the study, 
there was a meeting which included people who were convinced 
that secretin worked who said it was one dose, and we used the 
dose it was supposed to be; we used porcine-derived secretin--
and now, all of a sudden, the hypothesis shifts. Now, the 
hypothesis shifted to multiple doses--that is fine. The people 
who think it is multiple doses and single doses now have to 
test it. And if we have helped to refine the hypothesis so they 
can do a better study and show that it works, then I am fine 
with that.
    I recognize that basically, science cannot disprove 
anything. It is really meant to--you have to actually set up a 
hypothesis to tear apart to accept the other one. That is what 
I mean by part of the self-criticism of the scientific method.
    So absolutely--if this gets turned around in particularly 
children with projectile vomiting--that is a very rare group of 
autism--but somebody with projectile vomiting, maybe 30 kids 
like that, secretin would work wonderfully.
    Mr. Burton. Dr. Hirtz, we were talking about the study at 
Brick Township, NJ. I do not know if you heard me ask the 
question of the doctor from the CDC earlier. Why would you 
think that the National Institutes of Health and CDC and others 
would go into Brick Township, NJ and look at all the 
environmental problems that may have caused the autism epidemic 
they have had there, and when the parents asked that they check 
to see if any of the vaccines had anything to do with it, why 
would you think the health agencies did not check that as well?
    Dr. Hirtz. I am sorry, Mr. Chairman, I am not at all 
familiar with the study at Brick Township; that was conducted 
by the CDC, not the NIH, and I am afraid you will have to ask 
them questions about it.
    I would be glad to tell you about activities that the NIH 
is doing in this area, however, if you would like to hear some 
of them.
    Mr. Burton. What would you say about the NIH taking a hard 
look at the studies done by Dr. Wakefield, Dr. O'Leary, and Dr. 
Singh, and some of the theses that Dr. Megson espoused earlier?
    Dr. Hirtz. I think that examining scientific evidence is 
always a useful thing to do; there is nothing wrong with that. 
In terms of the vaccine issue, I would just like to say that 
you are right--we do need to keep our minds open. I do feel 
that at this time, the available, valid scientific evidence 
does not support that vaccine is a cause of autism.
    However----
    Mr. Burton. What bothers me about a lot of this is Dr. Cook 
and you say if there is a hypothesis that says this, it has to 
be proven before we will even take a hard look at it.
    Dr. Hirtz. No----
    Mr. Burton. Well, that is the impression that I am getting, 
and----
    Dr. Hirtz. May I finish?
    Mr. Burton [continuing]. Let me just finish. The problem is 
that there are a large number of children who have acquired 
this problem shortly after getting these vaccines, and when 
scientists and doctors from other parts of the world come up 
with a thesis, I think it is irresponsible to out-of-hand just 
discard that and say, well, that is something they have to 
further prove, because their hypothesis has not yet been 
proven. It seems to me that you say, hey, if there is a 
positive result there, if it looks like there may be something 
there, why don't we take a look at it, too, instead of keeping 
yourselves confined to one area?
    Dr. Hirtz. If you will let me finish, Mr. Chairman, I was 
going to tell you about all the efforts we are making to look 
at that. What I was going to say when I continued was that even 
though that is the case at the moment, we do take this very 
seriously, we take the concerns of the parents very seriously, 
and when we have reports like this and concerns like this, we 
do address them.
    We are taking three steps at the NIH, and we are 
undertaking three projects to look at the relationship of 
vaccines and autism. One of them is very immediate and is going 
to be done in the centers that now exist. The Child Health 
Network has Centers of Excellence in autism, and they have 
about 1,000 children enrolled. In conjunction with the Deafness 
and Communicative Disorders Institute and the CDC, they are 
going to look at the children who have regressed and look at 
their vaccine histories and study this issue, compare them to 
other children. That is going to be done as soon as possible, 
hopefully, this fiscal year.
    In addition to that study, something I have been working 
on, we are planning at the NIH to look at the very important 
issue of not only vaccines but risk factors for development of 
autism as well----
    Mr. Burton. I have had a number of people today testify 
from the health agencies that there is no scientific evidence 
that autism is related to vaccines. How do they know that?
    Dr. Hirtz. They do not.
    Mr. Burton. How do you know that? A vaccine is put out on 
the market, children all take it----
    Dr. Hirtz. On the----
    Mr. Burton [continuing]. Let me just finish--and there is 
an increase from 1 in 10,000 to 1 in 400 or 500, so we have an 
epidemic on our hands; and yet the health agencies of this 
country are telling us there is no connection between these 
vaccinations and autism. How do you know?
    Dr. Hirtz. I do not know that there is no connection. What 
I know is that the evidence that has been reviewed by the 
British Medical Research Council and the epidemiologic evidence 
does not support a large-scale causation. But I still think----
    Mr. Burton. How do you know that?
    Dr. Hirtz [continuing]. But I still think that there are 
and there may be certain children who are susceptible, and that 
is what we have to go after. It is very important that we look 
for why children develop autism and whether there might be a 
small minority of children who have some susceptibility, and we 
are not ruling that out.
    Mr. Burton. Yes. One of the things that concerns me--and 
pharmaceutical companies are extremely important; they employ 
an awful lot of people in my district and in Indiana; we have 
some great pharmaceutical companies that have saved a lot of 
lives and probably kept epidemics from happening around the 
world, there is no question about that--but there are so many 
people who work at CDC, HHS, NIH, and the other health agencies 
who have some kind of connection to the pharmaceutical 
companies and are on these advisory boards, that it causes one 
to wonder whether there is thorough research going into these 
things before they are approved.
    Does that concern you at all?
    Dr. Hirtz. At the NIH, we do not really deal with the 
approval process of the vaccines. Other agencies can tell you 
more about how they deal with that.
    What I am really concerned about--it is hard for me to 
convey to you that we really--there is nothing I would not do 
to stop autism from occurring and to stop children from 
developing this order, but I----
    Mr. Burton. Well, then, what I would suggest is that we are 
going to get all of these studies--I am going to get them--and 
we are going to send them to all the health agencies, and I 
want the health agencies to write back and tell me, after they 
do some research, whether or not they feel there is any merit 
to these arguments. And I want them to look at--and I will get 
other Members of Congress to join me if necessary--I want them 
to look at Dr. Wakefield, Dr. O'Leary, Dr. Singh, Dr. Megson--
all of the doctors who have come here today with various 
solutions that have worked--Dr. Upledger with his cranial 
manipulation. Those things should all be looked at, because we 
are giving the health agencies in this country billions and 
billions and billions of dollars, and for them not to look at 
every avenue for possible treatment for these things I think 
would be wrong.
    Let me just go down to the end of the table and give all of 
you a question--Drs. Rimland, Goldberg, Megson, Upledger, and 
Ms. Pratt.
    Do you think from what you have heard today and seen in 
your scientific research that there is a possibility that the 
vaccines are contributing to the increase in autism?
    Mr. Rimland. There is not only a possibility, there is an 
extremely high likelihood.
    Mr. Burton. Would you pull the mic closer?
    Mr. Rimland. There is not only the possibility, there is an 
extremely high likelihood from all the evidence available, 
including the so-called anecdotal evidence that people like to 
snicker at, but which is really very important evidence, from 
the kind of evidence that Dr. Wakefield submitted, from the 
rise in autism at the time of initiation of the MMR, the time 
of the rise of the epidemic, the data that I provided in my 
handout which shows that late-onset autism started at just 
about the same time that the MMR was initiated. There is just a 
world of evidence that leads me to think that it is extremely 
likely that when the final answer is known, if it is ever 
known, the MMR will be strongly implicated as an important 
cause of autism.
    Mr. Burton. Dr. Goldberg.
    Dr. Goldberg. With caution as I say this, as a practicing 
pediatrician, I have vaccinated children in my practice whom I 
considered high-risk--I have literally had a godchild with one 
foot in autism and one foot out and vaccinated her along the 
way. As I stated this morning, I however try to practice 
vaccination policies that I was taught 20, 30 years ago--you do 
not vaccinate an ill child; you use certain plans; I never gave 
a child a hepatitis B shot in the nursery yet. But I think that 
the effort to solve autism gets distracted by the fact that we 
do have a lot of children triggered off by some time 
correlation to the vaccine.
    As I mentioned in my testimony, I think that if we are 
going to understand this, we need to step back and figure out 
why there is a wealth of science that says, hey, the vaccines 
do not create this or cause it, and then we suddenly have this 
epidemic going on, and I really believe the way it will come 
out in the end, whether we do it in the next 6 or 8 months or 
in 10 years, is going to be that this will all tie in from the 
eighties and nineties with what is going on in our population 
and it is not specifically the vaccines, but the vaccines are 
playing a role in it.
    Mr. Burton. Would play a role in it.
    Dr. Goldberg. Pardon?
    Mr. Burton. The vaccine would play a role.
    Dr. Goldberg. Yes, the vaccines would play a role. But we 
need to understand why, suddenly, a population has become 
susceptible to those when they did so much good along the way.
    Mr. Burton. Dr. Megson.
    Dr. Megson. I am seeing more and more families that are 
completely devastated. I know one mother who has been very 
active in the parent support group in our local community has 
had three children. The oldest has severe dyslexia/ADD; the 
second one died of SIDS within 24 hours of DPT; and the third 
one is autistic.
    If my theories are correct, there is an organ in the neck 
at the base of the main artery to the brain called the carotid 
body, and we are disconnecting the pathway. When the oxygen-
level in the blood decreases in the carotid body, there is a 
signal sent to the respiratory center in the brainstem to 
increase breathing rates, and we are disconnecting that 
pathway.
    Recently they discovered that, oh, if you put children down 
to sleep on their backs, they do not die of SIDS. I think we 
really need to look at this.
    I do not want to be here. I have never gone against the 
grain. I am not a vaccine researcher. But once I discovered 
some of these connections, I do not think any of us can turn 
our backs. So many families are devastated.
    Mr. Burton. Thank you.
    Dr. Upledger.
    Dr. Upledger. I have to say yes, I do. As I stated earlier, 
I think there is a group of autistic children--and by no means 
do I say all autistic children--whose problems are due to 
membrane dysfunction. But I have learned to understand that a 
significant number of them do, and I can easily differentiate 
autism from childhood schizophrenia just based on the feel of 
the membranes.
    I think that the membrane is a place where several factors 
may go, and it can be, as I said, a fever due to a virus, it 
can be a vaccine reaction, it can be a traumatic delivery--it 
can be anything that creates a change in the membrane 
flexibility and growth accommodation.
    From the histories I have taken--and I have taken histories 
with autistic parents since 1975--it is more than coincidence 
as far as I am concerned. I do not know how many cases of 
anecdotes we need to consider that the anecdote has some 
validity, but it would appear to be that it is infinite. We 
still will not believe the anecdote. I happen to subscribe to 
the idea that if you study the anecdote, you might learn 
something.
    So I would go very strongly in favor of the idea that 
vaccines are potentially able to cause autism in terms of their 
effect on membranes. I think that membrane condition is 
probably largely influenced by genetic factors along with 
nutritional factors, along with toxic factors, and so on, so 
you have a susceptible membrane.
    I have opened up enough human heads that are not embalmed, 
that are maybe 4 or 5 hours old, and I can see the difference 
in the membranes, and when you look at the diagnoses, you begin 
to put 2 and 2 together.
    I think one of the major things that has happened in 
medicine is the meningeal membrane system has been given a very 
short shrift. It is a very important system. It has just come 
out recently--I cannot think of his name now, but a fellow from 
California, UC San Diego, I think, came out with evidence, very 
strong evidence, that 1 gram of dura mater membrane, which is a 
very small quantity of that membrane, carries 100 million 
single-domain magnetic crystals that are ferric.
    What does it take to change that? The brain itself has 5 
million per gram. Anything that interferes with electrical 
conduction or magnetic fields is going to screw up that brain 
function. When we stretch that base membrane laterally, why 
does the kid get better in terms of his emotion? Because I 
think we are improving the conditions under which his temporal 
lobes have to live. That is why. You can tear it all apart, and 
if you study temporal lobes, you can say, OK, temporal lobes 
cause autism. But what caused the temporal lobe, and what 
caused the membrane to not accommodate the temporal lobe? When 
you start looking at it that way, you start looking at multiple 
factors any one of which can be causal--and I put vaccine in 
that category.
    Mr. Burton. Thank you, Doctor.
    Dr. Pratt, do you have a comment?
    Ms. Pratt. I think it is a very hard issue, and from both 
the autism side of America and the Indiana Resource Center for 
Autism, our job is really to provide information for families. 
And it is very hard when you listen to very well-respected 
scientists and researchers like Dr. Cook, whom I have 
tremendous respect for--and I point him out because he is in 
Illinois, the State neighboring Indiana--it is very hard when 
you hear the testimony and the research that says there does 
not seem to be a link, and then, when you hear from the 
families their stories. Balancing that out is a very difficult 
thing, and I struggle with that, because I do not want all of 
us running down one path, hoping that, yes, at the end of that 
path is going to be a cure or the reason or whatever.
    I hope we can all keep our minds open to all possibilities. 
Again, to be an ethical and decent professional, I have to say 
to families that I am hearing some stories, and there is a 
possibility for it. Those families and the families that you 
have heard from today really cannot wait for the research to 
tell them conclusively that there is a relationship.
    I would say that in all likelihood, Congressman Burton, if 
your daughter had another child, she would take a very serious 
look at the usage of vaccinations with her third child, 
regardless of what the research tells her. That is the 
complexity of the issue.
    So, what you have heard over the last several hours today 
is a lot of different testimony and sometimes conflicting 
testimony, and I hope that what we will all focus on is trying 
to uncover the complex nature and perhaps the complex causes 
behind autism.
    Mr. Burton. Thank you.
    Let me just ask Dr. Cook one more question, and then I want 
to make a couple of announcements before we conclude.
    Dr. Cook, how do you account for these parents and these 
doctors finding the measles virus in the guts of these kids who 
have had the MMR shot?
    Dr. Cook. I am very interested in that finding because I 
think it is a fascinating finding even if it applies to one in 
1,000 kids with autism. Each child is very valuable. So first 
of all, realize that Dr. Wakefield is talking about a very 
small group of autism, with documented pathology, with 
vomiting--which, as I said, is quite rare in autism. I think 
that is an interesting finding that needs to be followed up.
    The next step of that may not be a link with vaccines and 
autism; it may be something quite more important in 
understanding what is happening with autism. So that some of 
what was presented today, it was very good to see data ahead of 
time; it is rare, and it is nice of them to share it. There is 
something about their work, particularly seeing more controlled 
data than I have seen before, that is very interesting, and I 
will be paying quite a bit of attention to, because we need 
every clue that we can get.
    Thank you.
    Mr. Burton. Very good; 1 second.
    [Pause.]
    Mr. Burton. Let me just ask you a couple more questions, 
Dr. Cook. Where do you see the autism rates in the next 10 
years? Do you see them pretty close to where they are now, or 
do you see them increasing?
    Dr. Cook. I think if we are talking about from the 
perspective of school districts, they will continue to rise, 
because I think we are still underestimating across all school 
districts.
    In terms of the actual prevalence, meaning all the children 
who have always been out there suffering from this, I do not 
see it going up that high. What I see is appropriately--and 
this is a very important, I think almost civil rights 
movement--these kids and families are being heard now. But I do 
not see this as an epidemic in the sense of prevalence. I see 
it as an epidemic in terms of a wake-up call that lots of kids 
and families have been suffering for a long time.
    Mr. Burton. So you are saying the 1 in 10,000----
    Dr. Cook. It was never--I do not know----
    Mr. Burton [continuing]. It was always a lot higher than 
that?
    Dr. Cook. I do not know of a 1 in 10,000. I know that 2 to 
4 per 10,000 is what DSM3 said, which was 1980 to 1987. And 
1987 has been referred to as around the time of an increase. 
That is when we went from DSM3 to DSM3R. The reason is DSM3 
said the child had to have a pervasive lack of responsiveness. 
Now, I do not know who these kids were who had autism then, 
because every child with autism is related; they are just not 
related in the same ways. So now you have increased the 
definition as of 1987--and I think I have lost the question. I 
am sorry.
    Mr. Burton. It was about the projected increase in the next 
10 years.
    Dr. Cook. Right. So the most important thing about the 2 to 
4 per 10,000 estimates is that they were often done by, well, 
let us say someone has come in to a university clinic, and you 
estimate that against the population. What has happened, which 
is better epidemiology since then, is you go knocking on every 
door.
    So I have heard 1 in 500 referred to more than just autism, 
but the best study where they knocked on every door, half a 
million in Japan, found 1 in 500 for autism. So I do not think 
we are estimating it yet in terms of its impact.
    Mr. Burton. Do any of the rest of you have any projections 
or guesses on that?
    Mr. Rimland. In California, the increase started in 1977 
before the diagnostic changes were made, so the switch from 
DSM3 to DSM4 cannot even begin to account for that.
    Dr. Goldberg. If I can tie in a projection, unfortunately, 
I can remember discussions back, literally, in the mid-eighties 
with clinicians, and at that time, the CDC, the NIH and 
everyone was saying this new entity out there that we were 
calling ``chronic fatigue syndrome'' or whatever it was 
supposed to be did not exist, or was not in any big numbers, 
and as clinicians, we were saying we were going to see 1 to 3 
percent of the population. Well, now we are in the late 
nineties, the numbers are getting very close to that, and we 
are now talking 5 or 10 percent.
    I think that if this is the same crossover to the children 
as was seen in adults, you can make a prediction that in the 
next 5 to 10 years, you may hit 5 or 10 percent of our 
population or more.
    One of the most scary moments in my life recently, 
literally, was coming back on a flight from giving talks in 
Australia. I remember there was literally not a family who did 
not know a family who did not know a family that either had 
chronic fatigue syndrome, ADD, or autism. My thoughts on the 
flight coming back were, well, where is Australia--near the 
ozone hole--but my big concern was that that was going to be 
our country 5 or 10 years later. In the last month, I have 
literally had three families in--this is only a year and a half 
from that flight--telling me they do not know a family that 
does not know a family that does not know a family. This is a 
major crisis.
    Mr. Burton. Any other comments?
    [No response.]
    Mr. Burton. Let me just end by thanking all of you. I 
really appreciate your being here. I have two grandchildren--
one got a hepatitis B shot and stopped breathing within an 
hour; the other one got nine shots in 1 day and had a 
temperature of about 105 and became autistic, slamming his head 
against the wall, running around screaming. That is two for 
two. I guess maybe I am just one of those unfortunate 
statistics. But I have got to tell you, I think the problem is 
much greater than we believe, and I do believe, I personally do 
believe the vaccines have something to do with it.
    Now, my position, since I am not a scientist, is really not 
one that most people are going to pay much attention to, or the 
parents who testified here today. But, what I do want to do is 
take all the scientific information that we have acquired today 
from you, from all the other doctors, and submit that to the 
health agencies of this country and ask them to do a thorough 
study of all of them to see if there is any validity to what we 
think the problem is. If they do that and do it thoroughly, and 
they report back to the Congress, it will be a real service to 
the American people.
    Yes, Dr. Rimland.
    Mr. Rimland. I think it is rather interesting that most of 
the official authorities are taking the position that the 
increase in autism is unrelated to the vaccine use.
    One of my favorite expressions--I do not know who said it; 
I heard it one time, and I have tried to find out who said it, 
because I think it is extremely true--is ``The chronicle of 
man's progress is the history of authority refuted.''
    Mr. Burton. Well, thank you very much.
    Thank you, ladies and gentlemen.
    I have two very quick announcements. The NIH is having a 
meeting for parents of children with autism tomorrow morning 
from 10 a.m. to noon at the Natcher Auditorium on the NIH 
campus in Bethesda. If you would like to attend, you are 
welcome to attend that.
    And we need to announce that the Unlocking Autism group is 
having a reception in HC-5 in the Capitol immediately after the 
hearing.
    Thank you very much. I appreciate your being here. We stand 
adjourned.
    [Whereupon, at 5:25 p.m., the committee was adjourned.]

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