[House Hearing, 107 Congress]
[From the U.S. Government Publishing Office]
AUTISM--WHY THE INCREASED RATES? A ONE-YEAR UPDATE
=======================================================================
HEARINGS
before the
COMMITTEE ON
GOVERNMENT REFORM
HOUSE OF REPRESENTATIVES
ONE HUNDRED SEVENTH CONGRESS
FIRST SESSION
__________
APRIL 25 AND 26, 2001
__________
Serial No. 107-29
__________
Printed for the use of the Committee on Government Reform
Available via the World Wide Web: http://www.gpo.gov/congress/house
http://www.house.gov/reform
U.S. GOVERNMENT PRINTING OFFICE
76-856 WASHINGTON : 2002
____________________________________________________________________________
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COMMITTEE ON GOVERNMENT REFORM
DAN BURTON, Indiana, Chairman
BENJAMIN A. GILMAN, New York HENRY A. WAXMAN, California
CONSTANCE A. MORELLA, Maryland TOM LANTOS, California
CHRISTOPHER SHAYS, Connecticut MAJOR R. OWENS, New York
ILEANA ROS-LEHTINEN, Florida EDOLPHUS TOWNS, New York
JOHN M. McHUGH, New York PAUL E. KANJORSKI, Pennsylvania
STEPHEN HORN, California PATSY T. MINK, Hawaii
JOHN L. MICA, Florida CAROLYN B. MALONEY, New York
THOMAS M. DAVIS, Virginia ELEANOR HOLMES NORTON, Washington,
MARK E. SOUDER, Indiana DC
JOE SCARBOROUGH, Florida ELIJAH E. CUMMINGS, Maryland
STEVEN C. LaTOURETTE, Ohio DENNIS J. KUCINICH, Ohio
BOB BARR, Georgia ROD R. BLAGOJEVICH, Illinois
DAN MILLER, Florida DANNY K. DAVIS, Illinois
DOUG OSE, California JOHN F. TIERNEY, Massachusetts
RON LEWIS, Kentucky JIM TURNER, Texas
JO ANN DAVIS, Virginia THOMAS H. ALLEN, Maine
TODD RUSSELL PLATTS, Pennsylvania JANICE D. SCHAKOWSKY, Illinois
DAVE WELDON, Florida WM. LACY CLAY, Missouri
CHRIS CANNON, Utah ------ ------
ADAM H. PUTNAM, Florida ------ ------
C.L. ``BUTCH'' OTTER, Idaho ------
EDWARD L. SCHROCK, Virginia BERNARD SANDERS, Vermont
------ ------ (Independent)
Kevin Binger, Staff Director
Daniel R. Moll, Deputy Staff Director
James C. Wilson, Chief Counsel
Robert A. Briggs, Chief Clerk
Phil Schiliro, Minority Staff Director
C O N T E N T S
----------
Page
Hearing held on:
April 25, 2001............................................... 1
April 26, 2001............................................... 307
Statement of:
Bradstreet, James J., M.D. FAAFP; Cindy Kay Schneider, M.D.
FACOG; Jeff Segal, M.D.; and Sharon G. Humiston, M.D....... 38
McCormick, Marie, MDSCD, chair, Committee on Immunization
Safety Review, Institute of Medicine, accompanied by
William Colglazier, executive officer, National Academy of
Sciences; and Susanne Stoiber, executive officer........... 202
McDougle, Christopher J., M.D., Riley Children's Hospital,
Indiana University School of Medicine; Andrew Wakefield,
M.D.; Walter Spitzer, M.D., Faculty of Medicine, McGill
University, Montreal, Canada; Boyd E. Haley, Department of
Chemistry, University of Kentucky; David G. Amaral, MIND
Institute, University of California, Davis; Dr. Elizabeth
Miller, Public Health Laboratory, England; and Dr. Michael
D. Gershon, Department of Anatomy and Cell Biology,
Columbia University........................................ 89
Rennert, Owen M., M.D., Scientific Director, National
Institute of Child Health and Human Development, National
Institutes of Health; Karen Midthun, M.D., Director, Office
of Vaccine Research and Review, Food and Drug
Administration, accompanied by Susan Ellenberg, M.D.,
Director, Office of Vital Statistics and Epidemiology;
Norman Baylor, M.D., Associate Director, Regulatory Policy,
Office of Vaccines; and Dr. Colleen Boyle, Acting Associate
Director, Science and Public Health, Center on Birth
Defects and Developmental Disabilities, Centers for Disease
Control and Prevention..................................... 314
Smith, Hon. Christopher H., a Representative in Congress from
the State of New Jersey; and Hon. Michael F. Doyle, a
Representative in Congress from the Commonwealth of
Pennsylvania............................................... 25
Letters, statements, etc., submitted for the record by:
Amaral, David G., MIND Institute, University of California,
Davis, prepared statement of............................... 160
Boyle, Dr. Colleen, Acting Associate Director, Science and
Public Health, Center on Birth Defects and Developmental
Disabilities, Centers for Disease Control and Prevention,
prepared statement of...................................... 354
Burton, Hon. Dan, a Representative in Congress from the State
of Indiana:
Letter dated April 24, 2001.............................. 4
Prepared statements of.................................. 7, 310
Clay, Hon. Wm. Lacy, a Representative in Congress from the
State of Missouri, prepared statement of................... 22
Doyle, Hon. Michael F., a Representative in Congress from the
Commonwealth of Pennsylvania, prepared statement of........ 33
Gershon, Dr. Michael D., Department of Anatomy and Cell
Biology, Columbia University, prepared statement of........ 178
Gilman, Hon. Benjamin A., a Representative in Congress from
the State of New York, prepared statement of............... 378
Haley, Boyd E., Department of Chemistry, University of
Kentucky, prepared statement of............................ 137
Humiston, Sharon G., M.D., prepared statement of............. 77
McCormick, Marie, MDSCD, chair, Committee on Immunization
Safety Review, Institute of Medicine, prepared statement of 205
Midthun, Karen, M.D., Director, Office of Vaccine Research
and Review, Food and Drug Administration, prepared
statement of............................................... 336
Miller, Dr. Elizabeth, Public Health Laboratory, England,
prepared statement of...................................... 164
Rennert, Owen M., M.D., Scientific Director, National
Institute of Child Health and Human Development, National
Institutes of Health, prepared statement of................ 318
Schneider, Cindy Kay, M.D. FACOG, prepared statement of...... 45
Segal, Jeff, M.D., prepared statement of..................... 68
Smith, Hon. Christopher H., a Representative in Congress from
the State of New Jersey, prepared statement of............. 28
Wakefield, Andrew, M.D., prepared statement of............... 96
Weldon, Hon. Dave, a Representative in Congress from the
State of Florida, prepared statement of Mr. and Mrs.
Middlebrook, Indialantic, FL............................... 219
AUTISM--WHY THE INCREASED RATES? A ONE-YEAR UPDATE
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WEDNESDAY, APRIL 25, 2001
House of Representatives,
Committee on Government Reform,
Washington, DC.
The committee met, pursuant to notice, at 11:07 a.m., in
room 2154, Rayburn House Office Building, Hon. Dan Burton
(chairman of the committee) presiding.
Present: Representatives Burton, Morella, Ros-Lehtinen,
Horn, Davis, Weldon, Waxman, Maloney, Norton, Cummings,
Kucinich, Blagojevich, Tierney, Schakowsky, and Clay.
Staff present: David A. Kass, deputy counsel and
parliamentarian; Mark Corallo, director of communications; John
Callendar, counsel; S. Elizabeth Clay, Nicole Petrosino, and
John Rowe, professional staff members; Robert A. Briggs, chief
clerk; Robin Butler, office manager; Michael Canty and Toni
Lightle, legislative assistants; Scott Fagan, staff assistant;
Leneal Scott, computer systems manager; John Sare, deputy chief
clerk; Corinne Zaccagnini, systems administrator; Phil Barnett,
minority chief counsel; Kate Anderson and Sarah Despres,
minority counsels; Ellen Rayner, minority chief clerk; and Jean
Gosa, minority assistant clerk.
Mr. Burton. Good morning.
A quorum being present, the Committee on Government Reform
will come to order. I ask unanimous consent that all Members'
and witnesses' written and opening statements be included in
the record. Without objection, so ordered.
I ask unanimous consent that all articles, exhibits, or
extraneous or tabular material referred to be included in the
record. Without objection, so ordered.
During the 106th Congress, I initiated oversight
investigations to look at the dramatic rise in autism rates and
the many concerns about vaccine safety. Autism rates have
skyrocketed. Conservative estimates suggest 1 in 500 children
in the United States is autistic. However, those rates are
dramatically higher in some places such as Brick Township, NJ,
where the rates are 1 in 150. I think Congressman Smith, who is
going to testify today, represents part of that area.
In the first quarter of this year a child was diagnosed
with autism every 3 hours in California. Last year, that rate
was every 6 hours. Look at that graph. They are having an
absolute epidemic out there.
Indiana is seeing a similar trend in increased rates; 1 in
400 children in my home State is autistic. Between December
1999 and December 2000, requests for special education services
for children with autism went up 25 percent. That is a 25-
percent increase in requests for taxpayer-provided services in
just a year.
We have a national and potentially worldwide epidemic on
our hands. It cannot simply be better reporting or an expanded
definition of autism. There has to be more to it than that.
As with any epidemic, we need to focus significant energy
and research on containing it. We need to locate the cause or
causes. We need to determine if this is the same condition we
understand autism to be or not. Could this epidemic of children
who regress into ``autism'' be another condition being called
autism?
We need to be aggressive in developing and making available
appropriate treatments for both the behavioral issues and the
biomedical illnesses related to this condition. And we need to
provide credible and timely information to the public. Has the
public health sector responded adequately and appropriately to
this epidemic? We will be hearing from witnesses over the next
2 days to find out.
Autism, or Autism Spectrum Disorder, is devastating to
families. I know this from personal experience. My grandson,
Christian, was born healthy and developed normally. His story
is not much different than that of the thousands of families we
have heard from over the last year. He met his developmental
milestones. He was talkative. He enjoyed being with people. He
interacted socially.
Then Christian received his routine immunizations as
recommended by the Centers for Disease Control and Prevention
and his life changed dramatically and very rapidly. We now know
that through his shots, he may have been exposed to 41 times
the level of mercury than is considered safe by Federal
guidelines for a child his size. This was on top of other
mercury exposure from earlier vaccinations.
Within 10 days of receiving his vaccines, Christian was
locked into the world of autism--within 10 days. Is it related
to the MMR vaccine? Is it related to the mercury toxicity? Is
it the environment, including food allergies? Or is autism
purely genetic? Some would have us believe that a child's
regression into autism within a short time of vaccination is
purely a coincidence. I ask those individuals to show me the
science that proves this theory.
On Monday, the ``Measles-Mumps-Rubella Vaccine and Autism
Report'' was released by the Institute of Medicine's Committee
on Immunization Safety Review. We have Dr. Marie McCormick, the
Chair of this committee, here today to talk about the findings
and recommendations of the report.
I realize the headlines over the last 3 days have said that
the committee found no connection between the MMR vaccine and
autism. I would urge all of you to read the entire report and
recognize that the committee found that there was insufficient
evidence to conclusively prove or disprove a connection between
the MMR vaccine and acquired autism. And yet, on television all
across this country, every parent saw that there was no
connection between the MMR vaccine and autism.
Yet, that is not what the report said. I believe a
disservice has been given to the American people about this.
Parents need to know the risks involved with certain exposures
their children have to face. And they need to have all the
facts, not part of the facts.
It should be noted that the committee notes in its
conclusions that it could not exclude the possibility that MMR
vaccine could contribute to Autism Spectrum Disorder.
In the scientific community, there is an accepted hierarchy
of research methodology that builds a balanced foundation of
the evidence. That is in attachment 1. What we learned from the
Institute of Medicine is that the research has not yet been
conducted to build this hierarchy of evidence regarding the
question of whether or not the MMR vaccine may be linked to the
increased incidence of autism.
We have substantial parental observation, which should
never be discounted. And we have several case studies and
laboratory evidence showing measles virus in the guts of
autistic children who have bowel dysfunction. And we also have
several population-level epidemiological studies.
While the Immunization Committee noted that the
epidemiologic studies do not support an association at a
population level, their report stated that ``it is important to
recognize the inherent methodological limitations of such
studies in establishing causality.''
In essence, the studies that have been published and held
up by the public health community as ``proof'' against Dr.
Wakefield's hypothesis can never answer the question of whether
or not MMR vaccine is linked to autism in some children. We do
not have enough research to make an evidence-based final
conclusion. What we have is a clear indication that a problem
exists for some children. We need to do the research to get our
arms around that problem, so that we can prevent any further
escalation of this epidemic of acquired autism.
When the Institute of Medicine formed their committee, we
were assured that there would be no one on the committee who
had ties to the vaccine industry. We were told there would be
nobody connected to the vaccine industry involved in the
research done by this committee. So I was disturbed to learn
that the committee sent this report out for review and comment
prior to becoming final to numerous individuals who have ties
to the vaccine industry, including the manufacturer of the MMR
vaccine.
They sent it out for critiquing, and there were changes
made by these other people outside. They also sent it to at
least one individual who presented to the committee, but not to
Dr. Wakefield and the rest of the presenters. This preferential
treatment is disturbing, and I would like to know why they did
not send it to everybody who was a presenter.
I am including in the record a letter I received from one
of the reviewers, and a previous witness to this committee
regarding his concerns about flaws in the evaluation of the
published research. He is with the University of Oklahoma, the
Health Center. And that will be included in the record.
[The information referred to follows:]
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Mr. Burton. I want to read just one part of his letter.
``The report highly criticizes the peer review publications
that cite a causal association of the MMR vaccine and autism
and does not provide a similar critique of the peer review
publications that cite a lack of association of the MMR vaccine
and autism.''
It also says, ``One of the publications that are used to
support the lack of the MMR vaccine and autism cites support of
Merck and Company in the acknowledgements.'' They are the
producer of the MMR vaccine.
This is not mentioned in the Institute's report and could
be considered potentially as a pre-existing bias. We want to
ask the person who is going to be testifying about the report
why that happened.
They also sent it to at least one individual who presented
to the committee, but not Wakefield.
I am including in the record this letter I received from
the reviewer about what he believes to be the flaws in the
evaluation of the published research. He also raises concerns
about the lack of the Institute's acknowledgement in their
evaluation that one of the publications used to support a lack
of a connection between the MMR vaccine and autism was
sponsored by Merck, the manufacturer of the MMR vaccine.
witnesses to stick to the time limit so we can get through all
the panels and have time for questions. We will be hearing
first from my colleagues and friends, the chairmen of the
Autism Congressional Caucus--which I am proud to be a member
of--Congressman Christopher Smith of New Jersey, and
Congressman Mike Doyle of Pennsylvania.
The record will remain open until May 11.
I apologize to Mr. Waxman for talking so long, but I feel
very strongly, as you know.
Mr. Waxman, you are recognized for an opening statement.
[The prepared statement of Hon. Dan Burton follows:]
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Mr. Waxman. Thank you very much, Mr. Chairman.
The issue of autism has been getting increased attention in
Congress over the last several years, and this attention is
overdue. I want to commend you, Mr. Burton, for your efforts to
increase public awareness about autism through these hearings.
Autism is a particularly frustrating disease. We still do
not understand what causes it and we still do not have a cure.
All we know for sure is that its impact on families can be
devastating.
During the hearings held in this committee, we have heard
parents tell tragic stories of children who appear to be
developing normally and then all of a sudden retreat into
themselves, stop communicating, and develop autistic behavior.
Other parents have testified that their children never start to
develop language skills, and instead early on manifest symptoms
of autism.
I can only imagine how frustrating and difficult this must
be for families. And I appreciate how urgently we need to
understand what causes autism, how to treat it, and if
possible, how to prevent it.
Fortunately, Congress is beginning to respond. Last year, I
co-sponsored a bill to increase NIH's funding for autism
research. This funding was authorized as part of the Child
Health Act, which I also supported.
This year, Congress' challenge will be to appropriate the
funding authorized by the Child Health Act. We will not make
real progress until we make sure NIH has the funding it needs
to research this debilitating disease.
At our first hearing last year, we heard moving statements
from the chairman and several witnesses that they had firsthand
experience with observing signs of autism shortly after
children received the MMR vaccine. These witnesses voiced their
suspicion that autism was caused by the vaccine.
I was deeply concerned about these remarks. Vaccines are
unique in medicine. Other medicines are administered to sick
people to make them better. But vaccines are given to healthy
children and they are mandatory in many States. When I heard
the chairman's concerns, I was disturbed by the possibility
that a vaccine that States mandate could be making healthy
children sick.
But at the same time, I was also worried for another very
different reason. Vaccines are one of the greatest success
stories in modern medicine. Because of vaccines, children no
longer suffer brain damage or die from measles or are paralyzed
by polio. I realize that publicizing fears that vaccines may
cause autism could cause some parents to stop vaccinating their
children. And I worry that this could be counterproductive. In
the name of protecting our children from autism, we could
actually be subjecting them to much greater risks of deadly or
debilitating diseases such as measles, rubella, damage
affecting developing fetuses or brain damage from meningitis.
The theory that the MMR vaccine may contribute to autism
had been carefully reviewed by the British Medical Research
Counsel, which found no evidence to support it. However, what
we needed, I believe, was more study. That is why I proposed
during last year's hearing that Chairman Burton join me in
requesting that the Secretary of Health and Human Services
convene a panel of experts to examine the theory that the MMR
vaccine could cause autism.
HHS responded to our request by contracting with the
Institute of Medicine, a branch of the National Academy of
Sciences, to convene a panel of independent experts to review
vaccine safety issues. The Institute of Medicine identified
potential experts and then subjected the experts to strict
criteria that excluded anyone who had financial ties to vaccine
manufacturers or their parent companies, previous service on
the major vaccine advisory committees, and prior expert
testimony or publications on issues of vaccine safety.
The first issue this independent panel considered was the
relationship between the MMR vaccine and autism. This panel of
independent experts convened by the Institute of Medicine
issued its report on the MMR vaccine this Monday. The report is
careful and analyzes all the scientific information available
and it concludes that there is no credible scientific evidence
establishing a link between the MMR vaccine and autism.
The Institute of Medicine report is consistent with the
findings of the British Medical Research Council. It is also
consistent with the conclusions of the World Health
Organization, the American Medical Association, and the
American Academy of Pediatrics. Taken together, the evidence
clearly demonstrates that the MMR vaccine is highly unlikely to
be a cause of autism.
The next vaccine issue the Institute of Medicine will
examine is whether there have been adverse effects from
thimerosal, a mercury-containing vaccine preservative. Because
of concerns about mercury in vaccines, FDA has acted to remove
thimerosal from the childhood immunization schedule. In fact,
the entire vaccine schedule is currently available without
thimerosal. From a public health perspective, the remaining
issue is whether FDA made the right decision in choosing not to
recall the thimerosal-containing vaccines that are still on
doctor's shelves.
FDA made the decision not to recall the vaccines because of
concerns about a potential vaccine shortage. While there may be
a theoretical risk to children from the thimerosal, FDA knew
that there is a very real risk to children if there is not
enough vaccine available to protect them adequately from
dangerous diseases such as whooping cough or diphtheria.
Moreover, FDA was also aware that the Centers for Disease
Control's surveillance has not shown any relationship between
thimerosal and developing mental delays.
Based on these facts, FDA's decision seems right, but I
will welcome any further insight that the Institute of Medicine
is able to offer.
I sympathize with the parents who have testified at our
hearings and who will testify today. I want them to know that I
am committed to doing everything Congress can to address the
problem of autism. It is clear to me that we need to research
aggressively the causes and treatments of autism.
Unfortunately, I believe the answers must come from science.
I thank the witnesses for appearing today and I look
forward to their testimony.
Mr. Burton. I thank the gentleman from California.
Mr. Horn, do you have an opening statement?
Mr. Kucinich, do you have an opening statement?
Mr. Kucinich. Thank you very much, Mr. Chairman, for
holding this hearing. And thank you very much, Mr. Waxman, for
making it possible for me to be a member of this committee.
I have to say, in having the opportunity to sit through
these committee hearings, I am taken with the concern for
public health that both of my esteemed colleagues have, Mr.
Burton and Mr. Waxman. I cannot say that I have formed any
conclusion about this because I think it is important to be
open to new evidence.
I do think it would be significant and important at this
moment to read from the summary from the Immunization Safety
Review from the Institute of Medicine, which says, ``The
Immunization Safety Review Committee concludes that the
evidence favors rejection of a causal relationship at the
population level between MMR vaccine and ASD. However, this
conclusion does not exclude the possibility that MMR vaccine
could contribute to ASD in a small number of children because
the epidemiological evidence lacks the precision to assess rare
occurrences of a response to MMR vaccine leading to ASD and the
proposed biological models linking MMR to ASD, although far
from established, are nevertheless not disproved.
Because of the limitations of the evidence, the significant
public concern surrounding the issue, the risk of disease
outbreaks if immunization rates fall, and the serious of ASD,
the committee recommends that continued attention be given to
this issue. This committee has provided targeted research and
communication recommendations. However, the committee does not
recommend a policy review at this time of the licensure of MMR
vaccine or of the current schedule and recommendations
regarding administration of MMR vaccine.''
It seems to me that this summary, which comes from the
document that is under discussion, does have an inconclusive
nature to it in the overall issue, even if it does not
recommend removal of licensure of the vaccine. So in exploring
the issue of this hearing, why the increased rates, I think the
persistence of our chairman on the issue of autism and holding
these hearings to update last year's work is well taken.
Often, hearings such as these raise more questions than
they give answers, and a determination for finding answers is
an example that researchers need to follow. In order to find
more answers, I do not believe we should narrow the scope of
the research. Rather, it is my hope that through the testimony
of parents, Dr. Wakefield, and others we will be able to gain a
broad view of the factors that may cause autism.
A recent report released by the Immunization Safety Review
Committee at the Institute of Medicine is important in this
regard because, again, I want to state the conclusion of the
committee that the evidence favors rejection of a causal link
between the MMR vaccine and ASD is not the whole story. Media
reports have seemed to focus on the first part of the
conclusion.
The second part of the conclusion, which is perhaps equally
important, is that there is not enough evidence. The committee
also concludes that the epidemiological evidence is lacking in
both breadth and precision. That, by definition, means that we
need to do more research. It means we need to do more specific
research.
And while I would agree with Mr. Waxman that given the
benefits of the vaccine, we do not want to be in a position
where we take the position for challenging health risks to a
broad spectrum of America's children, I believe we also need to
look at these increased incidents with a sense of mission to
find out exactly what is going on. The conclusion that the
review made also notes that biologic models that link the MMR
vaccine and ASD are fragmentary. The committee identifies the
limitations of the available evidence, which can only mean that
it is too soon to narrow our scope of possible answers.
Currently, there is $58 million in autism research funds at
NIH. Congress needs to focus on more funding for more research.
I would submit, instead of focusing just on the brain as the
sole search of autism research, we need to have a more holistic
approach and review the entire body system. Indeed, there is
some evidence--admittedly, limited--that shows that vaccine may
cause a physical reaction in the digestive system that may
cause autism.
Also, as I understand it, there is no conclusive research
on whether or not autism is caused by genetic factors or
environmental factors. We may need to look at food allergies,
vitamin deficiencies, and pollutants for their potential role
in causing autism. By looking at the entire human body and not
just the brain as the subject of research, we may find answers
to questions that we, as Members of Congress, the Autism
Congressional Caucus, parents, researchers, and others seek.
I look forward to the testimony of the witnesses. I
encourage Federal agencies and Congress to acknowledge their
testimony and have a broad scope in working to uncover the
cause of autism with additional and improved research.
Again, I thank the Chair.
Mr. Burton. Thank you, Mr. Kucinich.
Ms. Ros-Lehtinen.
Ms. Ros-Lehtinen. Thank you so much, Mr. Chairman.
I merely wanted to congratulate you once again for your
valiant efforts in helping bring this potential connection to
light. Perhaps there is a connection between the onset of
autism and the vaccinations, perhaps not. But I know it is an
important issue for this committee and it is something that
should be taken seriously.
I congratulate you for sticking to your commitment on this,
in spite of the overwhelming pressure you must be under from
the mainstream scientific community to let it go. I know in my
community we have many cases of autistic children, children
being tracked by the school system in a different manner. Maybe
we are just getting better with diagnosis, but it just seems
alarming to me, in my area of south Florida, the high number of
children with autism.
I think it is an important issue for our committee. I think
you have been a valiant leader in this fight. We do need to
improve the scientific evidence. We need to fund the research.
We need to educate doctors in a better way because many times
those symptoms are going by unnoticed and the pediatricians
just shrug their shoulders and say, don't worry, this is just a
phase that child is going through. So we need to improve
funding and we need to improve the education for the medical
community as well.
I want to thank you, Mr. Chairman, for being brave enough
to stick to your agenda and to keep our committee seriously
looking at the connection between vaccination and autism and
just raise the awareness on the issue of autism itself. And I
congratulate our colleagues, Mr. Smith and Mr. Doyle, for
forming this coalition, of which I am proud to be a member and
with which I am proud to be associated.
Thank you, Mr. Chairman.
Mr. Burton. Thank you, Ms. Ros-Lehtinen.
Mr. Clay.
Mr. Clay. Thank you, Mr. Chairman.
I welcome the opportunity to meet with the committee today.
I also welcome the opportunity to meet with my fellow Members
of Congress who are co-chairs of the Autism Caucus,
Representative Christopher Smith and Representative Michael
Doyle. I especially welcome the parents of autistic children
who are witnesses. It is noted that all of the parents on the
panel are doctors. Additionally, I welcome all other witnesses
of panels three and four.
Mr. Chairman, my No. 1 focus while I am in office is
children. I am a father, as are you, and I am especially
grateful that you extend that parental concern through this
committee. Autism is a developmental disorder that appears
within the first 3 years of a child's life. The exact causes
are unknown. Many scientists who study autism find that it
occurs during fetal development, while some speculate that
there may be a form or forms of autism that occur in the early
years of a child's life.
Some parents and researchers subscribe to the theory that
this form of autism may be caused by vaccinations. Presently,
no confirmed scientific basis links vaccinations with autism
and some of the studies that support some of these theories
have been discredited.
These are questions to which we must have answers. I have a
4-month-old son and a 7-year-old daughter. To you parents who
are witnesses today, your children could just as well have been
my children. This is an area that must be given all the
resources and attention necessary to find causes, effects, and
solutions.
At this point, Mr. Chairman, I would yield back the balance
of my time and ask unanimous consent to enter my statement into
the record.
Mr. Burton. Without objection, your prepared statement will
appear in the record.
[The prepared statement of Hon. Wm. Lacy Clay follows:]
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Mr. Burton. Dr. Weldon.
Mr. Weldon. I just wanted to mention my good friend from
Ohio, Mr. Kucinich, said earlier that NIH funding for autism
research is at $58 million. I believe that actual figure is
substantially below that, more in the range of $15 million. I
think there is going to be another hearing to get at that
issue, but I just wanted the record to reflect that.
Indeed, that is a big part of our problem. We are not
funding enough research in this arena. I thank you for calling
this hearing, Mr. Chairman.
Mr. Burton. Thank you, Dr. Weldon.
Mr. Cummings.
Mr. Cummings. Thank you very much, Mr. Chairman. Thank you
for holding this hearing today.
During the 106th Congress, the Government Reform Committee
held numerous hearings on vaccine safety and the theories on
the correlations between vaccinations and autism. Earlier this
week, the Institute of Medicine Committee on Immunization
Safety Review released a study that reported ``there is little
evidence of a causal link between vaccinations and autism.''
I agree with Dr. Steven Goodman of the Johns Hopkins
University of Medicine--which so happens to be located in my
district--who was a member of the IOM panel, when he said that
``the risk of not immunizing is much greater than any risk from
immunizing.''
Vaccinations provide important health protections so that
our children will not be at risk for a variety of illnesses and
diseases. Without vaccinations, the diseases we are now
protected from will return.
I applaud the CDC, the National Institute of Child Health
and Human Development, the National Institutes of Health, the
Food and Drug Administration, as well as the Kennedy Krieger
Institute and the Center for Development and Behavior Learning
at the University of Maryland School of Medicine in Baltimore
for their continued research in this area.
The causes of autism are unknown. There are some effective
treatments for some children, but there is no cure. My heart
goes out to parents, grandparents--like you, Mr. Chairman--and
families of autistic children. I am convinced that with further
research a cause and cure will be found.
I am also concerned that there have been approximately
2,800 cases of autism reported in my home State of Maryland. I
am also concerned about the rise in the number of autism cases
in California, New Jersey, and other States.
As such, I strongly believe that all theories for the cause
of autism must be objectively and thoroughly researched. I echo
the sentiments of the ranking member of this committee when he
expressed last year in the Los Angeles Times that autism must
not alarm the American people and steer them away from
vaccinating their children.
I welcome the witnesses here today. I look forward to the
testimony.
Thank you very much.
Mr. Burton. Thank you, Mr. Cummings.
Ms. Davis, do you have a comment?
Ms. Schakowsky.
Mr. Burton. If not, Congressmen Smith and Doyle, would you
come forward, please?
We will start with you, Mr. Smith. We normally swear in our
witnesses, but I do not think we need to do it with you, too.
Mr. Smith.
STATEMENTS OF HON. CHRISTOPHER H. SMITH, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF NEW JERSEY; AND HON. MICHAEL F.
DOYLE, A REPRESENTATIVE IN CONGRESS FROM THE COMMONWEALTH OF
PENNSYLVANIA
Mr. Smith. Thank you very much, Mr. Chairman.
I thank you and the members of the committee for allowing
my good friend and colleague, Mike Doyle, and I to be here on
behalf of our Coalition for Autism Research and Education
[CARE]. It is currently made up of 115 Members of Congress. It
is bipartisan. It was formed recently and we have our first
major briefing on Friday. The reason for the Coalition is to
try to sensitize Members to the need for more research dollars,
more focus on this very, very debilitating and heartbreaking
tragedy that has been experienced by increasing numbers of
Americans.
I think most of you know that autism is a developmental
disorder that has robbed at least 400,000 children of their
ability to communicate and interact with their families and
loved ones. The disorder, at least the common, prevalent number
used, is found in 1 of every 500 people in America, although
that number may have to be ratcheted upwards, given some of the
more recent evidence that is coming forward.
My interest in autism has been a 21-year interest. I first
got involved when the Eden Institute and Dr. Holmes in
Princeton, NJ brought me to one of their group homes and showed
me the kind of work they were doing. I worked with him and
others throughout the years to try to do what we could.
But, frankly, I have been amazed at what has not been done
at the Government level through the 1980's and into the 1990's
on this affliction, this disorder.
What brought me into it even more so in recent years--in
one of my largest towns, Brick Township, I became aware through
Bobby and Billy Gallagher, a very devoted husband and wife who
have two children with autism. They did their own study, if you
will, in Brick Township and found that there was an exorbitant
number of cases of children with autism. They became alarmed
and brought this information to me. They had the documentation
and we spent the better part of 3 hours reviwing it. In
subsequent meetings, it went on and on as we renewed it
further.
We finally brought the CDC and other Government agencies
into Brick. Frankly, I was amazed, shocked, dismayed, and
saddened by how little the CDC and some of our great Government
organizations knew about autism. It was as if the studies were
passive, the information collected was little to nonexistent--
and that includes in my own State. This began an effort to try
to do more, to try to at least get a handle on the prevalence
of autism.
What is happening? Is 1 in 500 real? Is it imaginary? Is it
fiction? And as you pointed out, Mr. Chairman, what is the
causation? Looking at your witnesses and knowing of your own
deep, personal commitment, I want to congratulate you at your
dogged determination to get at the reason. Why do we have this
terrible disorder seemingly cropping up in larger numbers in
our communities, as we saw in my own Brick Township, NJ? What
was found--and this was very disconcerting--after a
professional study by CDC, was that rather than 1 in 500, the
number was 4 per 1,000 in Brick. What are the reasons? Nobody
really has any answers. The questions and the answers we have
gotten in terms of numbers only bring about more questions
about why the prevalence? Why does there seem to be a cluster
or why do we have a higher number throughout the country?
Our own Department of Education in New Jersey has seen more
cases. Maybe this is just better reporting or maybe we have a
problem that is an epidemic that has gone largely unnoticed. In
1991 there were 241 cases. That has grown to an incredible
2,354 cases in 1999, an 876 percent increase. In just 4 years,
the number of autistic children aged 6 through 21 has more than
doubled. So we have a problem that really begs a significant
increase in funding, commitment, and prioritization within our
Government.
Last year many of us argued successfully that the amount of
money going to the CDC and NIH be increased. We are doing it
again this year, making a similar request to the appropriators
that more money for prevalence and other studies be
forthcoming.
Finally, Mr. Chairman, last year we did get a breakthrough
with the Centers of Excellence in Autism Epidemiology that was
contained in Public Law 106-310. I had introduced legislation
that had that in it. We worked with a number of organizations
and individuals. Mike Bilirakis, our good friend who chairs the
committee, put it as title one of his child health initiative
bill. Now that is awaiting full implementation so we can get a
better handle on autism with these new centers of excellence
looking at prevalence and other issues associated with it.
Again, I want to thank you for your leadership. Let me
offer one note of caution. I know the IOM study suggests that
there is not a link. And I know that one of their witnesses
will be here today to amplify that. But I chair the Veterans
Affairs Committee. I remember when the very first amendment I
offered dealt with the Agent Orange issue. Tom Daschle, now the
minority leader over on the Senate side, and I offered an
amendment to try to provide service-connection disability and
enhanced medical care for our veterans who had been exposed to
dioxin, the contaminant contained in Agent Orange.
For years, what we thought was credible evidence was laid
aside and they said there was no link, there is no link, there
is no link. Finally, in the latter part of the 1980's, the
evidence became so compelling that at least three anomalies
associated with that contamination were finally deemed service-
connected and were deemed worthy of compensation.
My hope is that this report not end the issue, but only
lead to more studies to find out what that causation really is,
because we really do not know. Again, it is encouraging. I am a
great fan and believer in immunizations. For the record, back
in the early 1980's, as a member of the International Relations
Committee--and you remember this well, Mr. Chairman--I offered
the amendment to create the Child Survival Fund and put $50
million in it. Now it has grown to over $200 million to
immunize the world's children against pertussis, measles,
tetanus, and other debilitating diseases.
So I am a great believer that immunizations save lives. But
if there is a problem, we need to be candid enough, aggressive
enough, and honest enough, for the sake of our kids, to go at
this and find out what is the causation. God willing, there is
no connection. But we need to pursue that aggressively.
Thank you.
[The prepared statement of Hon. Christopher H. Smith
follows:]
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Mr. Burton. Thank you, Mr. Smith.
Mr. Doyle.
Mr. Doyle. Thank you.
Chairman Burton and members of the committee, I thank you
very much for inviting me to speak with you regarding autism
and the goals and expectations for the Coalition for Autism
Research and Education [CARE].
I want to personally thank you for your interest in
expanding our knowledge of autism and autism spectrum disorders
and increasing research funding as well as for your members in
CARE. Your leadership has brought desperately needed attention
to a major children's public health issue that has been
neglected for the past 50 years.
As you know, autism is a life-long disorder that
significantly impacts the lives of those affected with the
disorder as well as the lives of parents and relatives. I need
not tell you, Mr. Chairman, of the profound effects autism has
on parents and loved ones who provide care for every 1 of these
1.7 million individuals. Autism changes lives forever.
Based on the latest evidence, we can safely say that autism
and autism spectrum disorders are now at an epidemic level here
in the United States with over 1.7 million individuals
affected. That is 1 out of every 150 to 170 children born.
During my tenure as Congressman, I have had numerous
meetings with concerned parents, researchers, and advocates who
are struggling to get autism research and treatment issues to
the forefront of lawmakers' minds. The vast majority are
frustrated by the lack of research and essential treatment and
services for their children. It is because of them, Mr.
Chairman, that I became committed to forming a congressional
organization for autism advocacy, along with my good friend,
Chris Smith, who I knew already had a strong interest in autism
from his work on the ASSURE Act last session, and the Coalition
for Autism Research and Education was born.
With CARE, our major goals are to ensure substantial
increase in research funding while ensuring that families
receive the highest quality treatment possible in accordance
with today's knowledge. If we accomplish these goals, the
number of children born with autism can be substantially
reduced and the revolution biologic treatments of the future
can be achieved for those who already have autism.
I join you in your grave concern of an autism-vaccine link
and feel strongly that we must examine what vaccines may be
doing to our children and thoroughly investigate the late onset
autism-measles vaccine connection. Identifying a vaccine-autism
link will help countless individuals who develop autism after a
vaccination, but we need to fully explore all possible avenues
to help those who develop the disorder by some other means.
In my view, we must learn to identify the genetic and
biologic basis of susceptibility to vaccine complications so
that children at risk can be identified and their vaccinations
delayed, while children not at risk can continue to receive
vaccinations and the protection from brain injury and death
that they provide. In addition, identifying the causes of
autism will not cure the 1.7 million individuals who already
have ASD. Research must also strive toward the revolutionary
biologic treatments of the future so that there is hope for
these children and adults. The decoding of the human genome
opens the door for the development of cures for autism in the
lifetime of children born with autism today.
The bottom line is that we need a lot more funding for
autism research. The opinions and testimony this committee will
hear are proof of that. I am concerned that if we focus the
lion's share of funding on one suspected cause of autism that
we could unintentionally pass up vital advances in other areas.
I want to provide a lion's share of the funding for research
into both the treatments and causes of the disorder equally for
the sake of all 1.7 million individuals and families that are
now living with the disorder, many of whom were born prior to
the introduction of vaccines.
Autism lasts a lifetime and often children with disorders
outlive their parents. We need to care for and educate autistic
children and adults, provide properly trained staff and
educators to meet the highly complex and specialized needs of
these individuals. All of this can become very costly over the
lifetime of an individual with autism. Steps must be taken to
reduce the disability associated with autism so that more and
more individuals can work and live semi-independently.
In my home State of Pennsylvania, the Autism Society of
America estimates that we have 73,686 individuals with autism.
Autism costs Pennsylvania an average of $50,000 per person per
year. It makes good sense to invest in research now so that we
can get quality services to families and realize the ultimate
payoffs of prevention of this disorder in the future and cures
for those children and adults who already have autism.
Continued funding of NICHD's 4-year-old Genetics and
Neurobiology Network must be maintained if we are to achieve
this goal. Combined with the creation and funding of at least
five new centers of excellence and three epidemiologic centers,
autism research in America can reach new heights and achieve
new breakthroughs for autism. Congress must continue to fund
existing autism research programs without taking away the much
needed funding for them to pay for new ones. I believe that any
expansion of research programs must come with a corresponding
expansion of funding dollars.
In closing, Mr. Chairman, in western Pennsylvania, we are
fortunate to have one of NICHD's collaborative programs of
excellence at the University of Pittsburgh. This 4-year-old
program is not only making a substantive contribution to the
understanding of neurobiology and genetics of autism, it is
providing guidance to State legislators in developing
surveillance and treatment centers in our State.
I would like to extend a personal invitation to you, Mr.
Chairman, and to each member of this committee to come and tour
this facility, as I have, meet the researchers and staff, and
speak to individuals with autism and parents about their
struggles and needs.
Mr. Chairman, I thank you for holding this hearing today
and for the opportunity to testify this morning.
[The prepared statement of Hon. Michael F. Doyle follows:]
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Mr. Burton. Thank you, Mr. Doyle.
Let me start with you Representative Smith.
In Brick Township, as I recall--and you may have to refresh
my memory--there were some toxic chemicals or something there.
What were those chemicals?
Mr. Smith. We had problems with a number of toxic
chemicals. As a matter of fact, we invited the ATSR, the agency
that looks for environmental pathways, to come in and they did
their own study and ruled out--based on the proximity of where
the children with autism lived and whether or not they were
close to the river----
Mr. Burton. What were the chemicals? Do you recall?
Mr. Smith. PCBs--there were a number of chemicals. It was a
witch's brew in essence of chemicals. They did look for a
number, and I could provide that for the record.
Mr. Burton. I would like to have that. Did they find any
mercury in there?
Mr. Smith. I do not believe they did.
Mr. Burton. But they found PCBs?
Mr. Smith. Yes, and others. We are a very industrial State
in the State of New Jersey. Many of those chemicals were dumped
into the river and got into the water system.
But despite concerns about that, when an overlay of where
the children were living was done, there seemed to be no
causation that could be attributed to an environmental pathway.
So they ruled that out.
Mr. Burton. How many were there?
Mr. Smith. There were 4 per 1,000.
Mr. Burton. So 1 in 250.
Mr. Smith. And 6.7 for the full spectrum.
Mr. Burton. Representative Doyle, you indicated that there
were 170,000 children in Pennsylvania who are autistic?
Mr. Doyle. Mr. Chairman, 73,686.
Mr. Burton. And you said that it cost $50,000 a year to
take care of those people that are autistic.
I guess the one thing I would like to point out to anyone
from CDC or health agencies, or anyone connected with our
Government--let's just say we reduce that $50,000 to half and
we only had to spend $25,000 per person for the rest of their
life to deal with their autistic problems. If 1 in 250 or 1 in
500 people are autistic, you are talking about so much money
that we cannot afford it. We are going to have people walking
around that are going to be lost and will be causing all kinds
of problems for our entire society. It could cause tragic
consequences for the entire country.
So there has to be more research done to find the causes
and if possible to find ways to minimize the damage done to
these people so they can be productive members of society.
I am very happy for both of you being here and for you
sponsoring and supporting and starting the Autism Caucus. I am
very happy to be a partner with you on that. Anything I can do
to help you get more money for this research, just holler. We
will be glad to do it.
With that, Mr. Horn.
Mr. Clay.
Doctor.
Ms. Schakowsky.
Any questions for any of our panelists?
If not, thank you both for being here. I look forward to
working with both of you. I appreciate it.
Our next panel is Dr. James Bradstreet, who will be
introduced by Congressman Weldon; Dr. Cindy Kay Schneider, of
Southwest Autism Research Center in Arizona; Dr. Jeff Segal of
Greensboro, NC, formerly of Terre Haute, IN; and Dr. Sharon G.
Humiston, of Plattsburgh, NY.
Would you all stand, please?
[Witnesses sworn.]
Mr. Burton. We want to try to confine the remarks. I know
you have prepared statements that are much longer than 5
minutes. But if you would, I would like you to stick as close
to the 5-minute limit as possible because we have 14 witnesses
today and we want to have time for questions.
Let me start with Dr. Bradstreet.
Dr. Weldon, do you want to introduce him?
Mr. Weldon. Yes, thank you, Mr. Chairman.
It is a real pleasure and honor for me to be able to
welcome and introduce my good friend and colleague--that is,
medical colleague--from the Melbourne-Palm Bay area, Dr. Jeff
Bradstreet.
Dr. Bradstreet is well known to the community I live in,
both as a practicing family physician and also for a radio
program that was carried nationwide, the Good News Doctor. He
is a fellow of the American Academy of Family Physicians. With
the development of autism in his son, he has emerged as one of
the leading practitioners in treatments of autism and currently
receives referrals from throughout the country from parents who
have been devastated by this disease.
It is a real pleasure for me to be able to welcome you, and
I am looking forward to your testimony as well as that of all
the other witnesses we have today.
Mr. Burton. Thank you, Dr. Weldon.
Dr. Bradstreet.
STATEMENTS OF JAMES J. BRADSTREET, M.D. FAAFP; CINDY KAY
SCHNEIDER, M.D. FACOG; JEFF SEGAL, M.D.; AND SHARON G.
HUMISTON, M.D.
Dr. Bradstreet. As a minor introduction to myself, I had
absolutely no interest in autism until it affected my son, at
which time--in a very short amount of time because of a
complete lack of local resources--I wound up having to dedicate
myself full-time to this activity which, in the end, was
apparently a blessing.
[Slide presentation.]
Dr. Bradstreet. This is just to remind us that we cannot
over-focus our attention on just the vaccine issue. There is a
host of environmental toxicological issues that may be
interacting with the vaccine constituents to cause problems,
and this U.S. News article points to that.
I want to point your attention to this, which is from the
November 17, 2000 Oregonian. There are now over 3,000 children
in Oregon--I am in Florida, but I was lecturing in Oregon and
meeting with researchers at the medical school. That makes a
prevalence of 1 in 190 students. The national average,
actually, based on recent statistics I have been able to
acquire from the Internet--the reference of which are all in my
written statement--may be as low as 1 in 140. That is an
extraordinary prevalence.
I also want to point your attention to the red line, which
shows the point in time that we introduce the infant HiB
vaccine and shortly after that, the Hepatitis B vaccine to
newborns on the first day of life--what happens to the
prevalence of that disorder in Oregon during that period of
time.
This is from the U.S. Census on Americans with
disabilities. The blue arrow is slightly above, but that number
is 1.8 percent of children under 3 being labeled as
developmentally delayed--which is a synonym for autism, in many
cases or certainly autism spectrum disorders.
If you go to the 3 to 5-year-olds, that is 2.7 percent of
children that are labelled developmentally delayed by our U.S.
Government. I would tell you that is a multi-trillion-dollar
problem coming that you are going to have to deal with, and
that is a huge prevalence. That is an epidemic by anybody's
standards.
This is the British Medical Journal article that is so
famous or infamous in terms of supposedly refuting the
incidence of autism-MMR relationship. Again, I do not want to
over-focus on any one particular vaccine, but look at when the
infant HiB was introduced into England with that red arrow and
what happened to the incidence at that point in time. Is there
an interaction between MMR components and HiB? Is there science
behind that? I would tell you that there probably is. This is
from the Mayo Clinic. Briefly, this is a 2000 article that came
out in the American Journal of Gastroenterology that said that
measles virus infection is associated with inflammatory bowel
disease. The IOM report states that no cases of vaccine
encephalitis have ever been reported, but what about this case
that came out in 1999 that says that measles-inclusion
encephalitis caused by the vaccine strain of measles was proven
using PCR data.
In addition to that, the IOM report also states that MMR
may be associated with inflammatory bowel disease, but
concludes that it is still safe. This is from the recent
Journal of Pediatrics about a month or so ago that shows that
there is in fact marked autoimmunity in these children's
intestinal tract. This is most likely an autoimmune disorder in
general.
This is the parent's view of what it looks like.
That is what for 4 years of my son's life I got to change
about three or four times a day and my wife got to change
another three or four times a day as he had chronic diarrhea.
The parents have a rather dim view of what chronic inflammatory
bowel disease and autism look like.
I want to let you know that it can be fixed. This is part
of my Christmas card from one parent thanking me for the fact
that in fact it is nice to have a child with a well-formed
bowel movement. And that child is doing extraordinarily better
now that the enterocolitis is taken care of.
Autoimmunity is a process where the immune system gets
confused and turned around and thinks that maybe the child is
at fault for this.
Myelin, which is the insulator of the brain nervous system,
is clearly a problem and there are many things that we are
finding in the kids that are abnormal that are affecting
melanization. The vaccine constituents may be part of that.
Just briefly, there is a host of credible science that
autoimmunity and vaccines are related. We are seeing in our
clinic of over 1,000 children in Florida, who come to us from
all over the world--in fact, I will be leaving shortly to spend
2 weeks in Indonesia where, after instituting a World Health
Organization vaccine program, they went from essentially no
autism to an epidemic in Indonesia, as well. I have been hired
to go over there for about 2 weeks to work with the government
and teach doctors how to take care of this disorder.
I am a clinician and I have to take care of kids. This is a
little difficult for you to read, but it is in my report. Let
me just state that this is from the Utah State University. This
is cerebral spinal fluid of a child who regressed after an MMR
vaccine that shows autoantibodies to myelin basic proteins
being positive as well as measles virus in the spinal fluid.
All other variables were negative.
I would conclude from that--as did the physician and the
researchers who have looked at this--that in fact that is an
MMR reaction in this child since there was no measles in this
child's history.
This just shows that it is not just Dr. Singh at the Utah
State University, but myelin basic protein antibodies are
prevalent and we can find them at many different laboratories.
We also know that Hepatitis B is an issue, and this shows
that as early as 1985 we knew that Hepatitis B constituents had
protein peptides that could in fact induce autoimmune
encephalitis in rabbits through molecular mimicry. These are
the same proteins we are injecting into our children.
We know that the French have identified a problem with
demelanization following Hepatitis B vaccine. We see problems
with melanization in autism every day in our facility.
This is a quickie just to show you that while there are a
lot of different peptides out there, hemophilus peptides do
induce autoimmunity to myelin basic protein from the Journal of
Immunology in 1999.
Exposure to mercury and other constituents will induce the
same autoimmunity to brain elements, and that is a review
article that has over 174 references. Is mercury a problem? It
is certainly in the vaccines.
This shows just a brief overview of the amount of mercury
that is available to children through the vaccines. It is a
tragedy. There is a lot of mercury in our environment. It
should not have been in the vaccines.
This is my son's first mercury test. That little dot on the
fourth column on the left that says toxic elements is in fact a
very high level of mercury. That is 15.7 parts per billion,
which is extremely high. This is his first post-provocational
urine using a standard procedure that has been developed; 24
micrograms per gram in his urine.
This is a New Jersey family--for Mr. Smith. This is a heavy
metal study from a child.
This is a 6-year-old with autism.
That is his first post-provocational urine. It shows
extraordinarily high levels of lead and mercury. One would
conclude that perhaps this is an environmental exposure, so I
tested the entire family, trying to be a good doctor.
Look at Mom. Mom is a nurse, Mom has had some vaccines, Mom
has a lot of amalgams, but look at that. Mom's mercury is not
too bad. Maybe it is not too bad.
Maybe Dad is a battery factory worker--actually, Dad is an
engineer, but let us go to Dad. Dad shows very little. He does
have some amalgams as well.
How about a 4-year-old sibling that has never been
vaccinated that has grown up in the same household. There is
essentially no mercury in that child. That causes me, as a
physician and as a clinician great concern. In this situation,
it looks like heavy metals are a problem. The only place I have
to look--the only difference between one child and the other--
is vaccination.
Is mercury toxicity a problem in autism? That bottom line
on that graph is a mercury level that is so high it could cause
neurological developmental disorders. The zinc level is almost
at critical levels of deficiency. Those two combinations cause
problems.
In summary, TH-1 and TH-2 imbalance where marked TH-2
insult has occurred through the vaccination program is well
documented from researchers at the University of California at
Irvine. TH-2 causes autoimmunity as vaccine-related. We see it
in our kids every day.
That is basically the issue we think that thimerosal plus
environmental mercury causes the initial TH-2 skewing and
autoimmunity. Aluminum adjuvants, which are in the vaccines,
adds to that infant. Infant HiB, again, is a strong TH-2
impulse agent. Newborn Hepatitis B is another TH-2 agent. All
these so far have been associated with autoimmune reactions,
with the exception of aluminum.
Pertussis is a TH-2 potent stimulator. This is an immune
system within the child that is primed to react so that when
MMR does come along, we are going to see autoimmune reactions
to brain and to bowel. We see it every day. This is an epidemic
of neurodevelopmental catastrophe.
This is my son at the Smithsonian. That is what I think
autism must feel like to children and to families. That is a T-
Rex--big teeth, big problem. But we do know that with love,
prayer, and sound medical behavioral action, this does not have
to be a catastrophe and there is hope.
The last picture is how Matthew is today. He is a happy
well-adjusted child, who is much better.
Thank you.
Mr. Burton. Dr. Bradstreet, thank you for that very
informative testimony. I will have a number of questions for
you.
Our next speaker will be Dr. Cindy Kay Schneider of the
Southwest Autism Research Center.
Dr. Schneider. Good morning, Mr. Chairman and members of
the committee. My name is Dr. Cindy Schneider.
I would like to express my gratitude and that of the
hundreds of families I represent to Representative Burton for
his scrutiny of the medical issues related to autism and his
leadership in bringing these concerns to your attention.
In 1995, my son Derek and daughter Devon were diagnosed
with autism. After visits to several specialists and series of
medical tests, we were left with a diagnosis and nothing more.
No treatment, no plan of action, and no hope.
The following year, Dr. Ron Melmed, Denise Resnik, and I
founded the Southwest Autism Research Center, a nonprofit
organization dedicated to serving the needs of individuals with
autism. We developed a questionnaire for the purpose of
obtaining medical, developmental, behavioral, and family
histories. We began to send laboratory specimens to researchers
around the world.
This became the infrastructure of a data base which now
contains information on approximately 500 children with
autistic spectrum disorders, their siblings, and 200 unrelated
controls. Many of these children have undergone extensive
psychological testing through our center and hundreds have
participated in clinical research trials. In this very limited
time, I would like to share with you the highlights of our
findings.
We looked first at patterns of development; 60 percent of
children in our data base spoke their first word prior to 18
months of age, indicating that early language development was
usually intact. The majority of children acquired motor skills
at the expected age as well.
Because my children experienced a distinct loss of language
and deterioration in health after their first year of life, I
looked for this pattern in other children. When asked if their
child had a normal or near-normal period of development
followed by regression, nearly 80 percent of parents told us
yes.
The most frequent age of regression was between 13 and 18
months. Consider the possible explanations for this
deterioration. These might include a metabolic defect which
over time results in neurological damage in a previously
healthy child. Exposure to toxins in the environment could do
the same. Infections, either naturally occurring or acquired
through vaccination, must also be considered.
For the past 3 years, we have collaborated with researchers
in Rome on a genetic screening project. Antonio Persico and
Flavio Keller have conducted detailed evaluations of 184
families in Italy and the United States, including 44 of our
children at SARC. Investigation of four candidate autism genes
revealed that three have little effect on a child's risk of
developing autism. The fourth gene is related to reelin, a
protein critical in early brain development.
In the Italian population, carrying a variant of this gene
more than doubled an individual's probability of having autism.
In the American subjects, the risk of autism associated with
the inheritance of this allele is 19 times the usual risk; 20
percent of individuals with autistic spectrum disorders carry
this gene. The inheritance of the long allele of this gene
results in a lower production of reelin. Interestingly, viral
infection further reduces reelin production and may explain
frequent reports of children's deterioration into autism
following illness or vaccination.
Other research at SARC has focused on the health problems
associated with autism. Of the 500 families interviewed, 48
percent reported that their children have a history of chronic
diarrhea, chronic constipation, or alternating gastrointestinal
symptoms. The increased incidence of bowel disease in
individuals with autism has been confirmed by multiple
investigators over the past 4 decades, yet has been largely
dismissed by the physicians caring for these children.
Our interest in the gut-brain connection intensified in
1997 when we learned of several children with autism who
experienced remarkable improvement following the administration
of a gastrointestinal hormone called secretin.
In 1998, we initiated the first clinical trial of the
safety and efficacy of synthetic human secretin in the
treatment of autism; 30 children were enrolled in this phase
one study. Improvements were noted in language, social
awareness and interaction, sleep pattern, and gastrointestinal
but were not captured on standardized psychological and
language tests. We saw that some children benefited from this
treatment, yet the study of this heterogeneous group failed to
demonstrate this benefit.
Over the past year, we have collaborated with Repligen
Corp. and four other sites across the country in the first
phase two clinical trial ever performed in the treatment of
autism. There were 126 children who completed this double-
blind, placebo-controlled study. Each child received three
doses of either synthetic human secretin or placebo at 3-week
intervals.
Unlike previous secretin studies, enrollment was restricted
to children between the ages of 3 and 6 who met strict
inclusion criteria. These criteria included a diagnosis of
childhood autism, a moderate to severe level of impairment,
little or no language, and significant gastrointestinal
symptoms. In addition to formal psychological testing, we asked
parents to report their children's status at the completion of
the study using a clinical global impression scale.
Treatment with three doses of secretin produced a
significant decrease in the symptoms of autism in 42 percent of
children, while 27 percent in the placebo group improved.
Further data analysis is underway and will take several months
to complete, but early findings indicate a biochemical market
which may predict secretin response.
Additional research planned at the Southwest Autism
Research Center includes expansion of our current data base
through recruitment of additional families and extensive
medical and behavioral assessments of these children. Genetic
testing for candidate autism genes and screening for several
metabolic defects will be performed.
An associated research priority will be the establishment
of a sibling screening clinic in which younger siblings of
children diagnosed with autism will undergo the same testing.
The recurrence rate of autism is approximately 5 percent,
meaning that parents of a child with autism have a 5 percent
change of having another affected child. Siblings age zero to
3, the age of onset for autism, will be evaluated every 3 to 6
months. In this way, identification of risk factors will
facilitate diagnosis and treatment at the earliest possible
age. This program will also allow prospective data collection
related to the natural history of autism, its associated
biochemical distinction, and the role of suspected
environmental variables.
The establishment of these programs on a national level
could allow the genetic environmental variables responsible for
the development of autism to be identified in the foreseeable
future.
I thank you for your attention to this subject and look
forward to participating in the materialization of this vision.
[The prepared statement of Dr. Schneider follows:]
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Mr. Burton. Thank you, Dr. Schneider, Dr. Bradstreet, and
the others.
Do we have copies of your studies? I would like to have as
much documentation from all of you as we can get because we are
going to have the people from HHS and FDA here. I want to
submit your studies to them--along with Dr. Wakefield's and
others--and ask them to give us an evaluation of those studies
based on their report and their research. In other words, I
want to get a comparison.
They are saying one thing and you guys are telling us
something else.
Dr. Segal, welcome. It is nice to have a Hoosier here--
although we love you guys, too.
Dr. Segal. I was born in South Bend, by the way.
Mr. Burton. Once a Hoosier, always a Hoosier. [Laughter.]
Dr. Segal. Mr. Chairman and members of the committee, thank
you for the opportunity to speak.
In October 1999, I became a member of a club I never wanted
to join. My son was given a diagnosis of regressive autism.
I am the father of 4-year-old twins, a boy, Joshua, and a
girl, Jordan. I practiced as a neurosurgeon. My son developed
normally and hit all of his milestones. He was jolly, sweet-
natured, and very bright. Before his second birthday, he
started losing the language he had acquired. He became
hyperactive and inattentive to the point that I though he was
deaf.
By the time a physician confirmed the diagnosis, my wife,
Shelley, and I already knew. We were devastated.
I investigated treatment options. The first treatment
consisted of occupational therapy to address his sensory
issues. The other early intervention that we chose was called
ABA, or applied behavioral analysis. ABA breaks down everyday
actions into discrete steps. The training is delivered as one-
on-one therapy and involves 40 hours of work a week. It is
expensive, exhaustive, and extremely time-consuming. Most
families we spoke with were on waiting lists for ABA treatment.
As time was our enemy, we moved to North Carolina. I quit my
practice and devoted my time to investigating biomedical
options.
At this point, I am pursuing three main projects. First,
help my son. If I can help him, I can help others. Next, I am
researching toxicologic causes and treatments as it relates to
autism. I am doing this in concert with the Department of
Physiology at Wake Forest School of Medicine. Finally, I am
exploring pharmaceutical options. I dug deep into my right
pocket and started a drug company based on medications that are
likely to be relevant to helping those with autism. At the same
time, it turns out it is probably relevant to treating
Parkinson's, schizophrenia, and other illnesses.
I have a few observations I would like to make.
The number of children with autism or related disorders is
rising. Do not take my word for it and do not ask physicians.
We need to ask teachers. These kids are filling regular and
special education classrooms to over-capacity.
We have heard the argument that the number of kids with
autism is static and that doctors are just better
diagnosticians. I have two points. Where are the autistic
adults who were never diagnosed 20 years ago? Surely they have
to be somewhere. Also, physicians spend less time than ever
truly talking with patients and families. More diagnoses are
made by tests and machines. No laboratory test exists for
autism. The diagnosis is based strictly on clinical
examination. Finally, the average time between onset of
autistic symptoms and diagnosis is still years. We are not
better diagnosticians.
The California Department of Developmental Services is
adding one new child with full-blown autism every 3 hours.
Estimates vary, but we are looking at approximately $2 million
to raise an autistic child to age 21.
The number of physicians who have a deep understanding of
autism treatment is small. These doctors are overworked and it
takes months to get an appointment. Many of these doctors have
affected children of their own. Since autism is a systemic
condition that involves that GI tract, immunologic system, and
central nervous system, it requires expertise by multiple
specialists. Finding all the specialists who have an interest
in treating autism can be a daunting task.
The statistics quoted by academicians are at odds with
reports by parents. For example, the standard autism literature
does not even recognize a general connection with the GI tract
and autism. However, families report that up to 80 percent of
their children have GI problems. Standard literature suggests
that only 20 percent of autistic children regress, that is,
they develop normally until age 2 and then become autistic. The
majority of parents that we see report that their children fall
into the regressive or acquired category.
Andrew Wakefield has theorized about a connection between
GI problems and autism. His work suggests that the measles
virus from vaccines might persist in GI tissue. This
association might also have a causal role in autism. This work
urgently needs replication, yet many gastroenterologists
conveniently dismiss his work rather than test his theory.
Incidentally, it would not be difficult to validate or refute
his hypothesis.
Eighty percent of autistic children have abnormal EEG
activity in brain areas associated with speech. It is believed
that these abnormalities might contribute to language deficits.
Correct diagnosis requires at a minimum an overnight EEG. Most
kids are given a 1-hour EEG, informed that it is normal, and
never properly treated. Not infrequently, the EEG is normal,
and a more sensitive test called the MEG is abnormal. MEG is
located in only a handful of cities and is quite expensive.
Insurance companies do not readily pay for this test. Once
correctly diagnosed, children may be given anti-seizure
medication, which can help.
Speaking of insurance companies, they do not readily pay
for much of anything that is autism-related. Laboratory tests
are paid out-of-pocket by parents and most research is being
borne at the parent's expense.
ABA treatment is extremely expensive. It works for about
half of the children. Costs are approximately $30,000 to
$70,000 a year. The parents will frequently turn to school
districts to make these treatments available. Where one lives
determines the type of treatment one receives. It is not
uncommon for the school district to litigate against parents so
they will not have to provide that service. The alternative is
placing children in large classrooms. This effectively
warehouses the child and minimizes potential for future gain.
Waiting lists for services are all too common.
I could spend a lot of time talking about the need for
toxins research, but I would like to touch on this for just a
second.
The Centers for Disease Control recently reported that 1 in
10 women of childbearing age in the United States are at risk
of having newborns with neurological problems due to mercury
exposure. Until recently, vaccines had thimerosal as a
preservative. Thimerosal is a preservative that contains
organic mercury.
Organic mercury is widely recognized as a neurotoxin. In
one study, lower or scores neurologic function tests were found
years later in children who had been exposed prenatally to
intermittent doses of methyl mercury. These doses happened to
be from dietary exposure at levels that had been previously
thought to be safe.
The vaccine manufacturers, to their credit, have stopped
making new vaccines with mercury as a preservative. But many of
these vials still sit on doctors' shelves. Also, RhoGAM is
given to RH negative mothers and this medication still has
thimerosal.
As an anecdote, I spoke with two fertility doctors. They
were not aware of the mercury issue. They were livid that this
type of medication had a preservative that had ``cleared''
safety tests and was being given to a pregnant woman.
With more vaccines being recommended to an already-full
vaccine schedule, and many vaccines administered earlier in
life, the potential for mercury toxicity in children is quite
real. The symptoms of mercury poisoning and autism are quite
similar.
I recently analyzed 250 hair samples and found that 30
percent of these children had tested two standard deviations
above the mean for various metals: aluminum, arsenic, and
antimony. These agents are ubiquitous in the environment. It is
my belief that autistic children may not be able to clear these
toxins from their bodies.
Chelation treatment is one way to remove metal toxins from
the body. It uses compounds that have a propensity to grab
metal toxins. There are many unanswered questions regarding
chelation. I say that historically the reputation for chelation
is quite poor. And I say this as a physician who had never
previously entertained the idea of chelation for any chronic
condition. It is extraordinarily difficult for a practitioner
to get funding to study chelation. It is just as difficult to
get doctors to consider it as a viable treatment.
My scientific work is focused on analyzing genes and
proteins that detoxify heavy metals in autistic children. My
hypothesis is that some children are genetically predisposed to
the inability to detoxify the metals to which they are exposed
to in the environment. These metals may come from vaccines,
food, or the environment. The major detox pathway for heavy
metals is metallothionein or MT. I am researching whether or
not these children have defective MT genes or if they are
unable to make appropriate amounts of this protein in response
to the insult. This could explain why not all children exposed
to the same environmental insult develop autism.
I will close, knowing I am well over the time.
We need immediate and abundant funding for research,
particularly treatment. We need to fund fellowships to increase
the number of skilled doctors who are treating autism. We need
to mainstream autism as it relates to insurance payments. It is
a biological condition and should not be constrained by policy
limits on mental health coverage.
We need to standardize payments for ABA treatment across
the country. It is unfair that some families are on waiting
lists for 2 years to access coverage.
We need to get the vials of thimerosal-containing vaccines
off the shelves through recall.
Mr. Burton. Amen.
Dr. Segal. We have adequate stocks of vaccine. It is not a
problem at this point. We need to clear the shelves. And
doctors do not know what is sitting on their shelves. We also
need to remove thimerosal from RhoGAM.
We need to seriously test the hypothesis that vaccines are
not always as safe as is currently believed. In addition,
combinations of vaccines have potential risks that have never
been explored. I clearly understand the public health import of
diseases we are preventing, but we need prospective studies.
Finally, licensing boards need to be less heavy-handed to
doctors offering off-label treatment to families that are
desperate for treatment. Off-label use of medications is common
in all fields of medicine. The standard by which these
physicians should be judged is risk versus benefit.
Thank you for your time.
[The prepared statement of Dr. Segal follows:]
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Mr. Burton. Before we go to the next witness, let me tell
you that every Congressman who got a flu shot from the Capitol
Hill physician--they do not know this--but they all had
thimerosal injected into their bodies. They all had mercury put
into their bodies. I got the shot and afterwards I looked at
the insert and found that.
There are a lot of people who believe--like you do--that a
number of senior diseases, like Alzheimer's, could be
contributed to by us having injections of mercury. And nasal
sprays the doctor gave me, the preservative was thimerosal. So
we are getting mercury in all kinds of things, not just for
children, but for adults as well.
So to my colleagues, if you had a vaccination for flu--and
I went over to see the doctor, who is a wonderful doctor and a
good friend, and he did not know it was in there.
Dr. Segal. And it is followed with a tuna fish sandwich, to
boot. [Laughter.]
Mr. Burton. Now, do not start telling me I cannot eat tuna
fish. [Laughter.]
Dr. Humiston.
Dr. Humiston. Thank you for inviting me to speak on behalf
of my son, Quinn.
I wish you could meet Quinn. He has big eyes as brown as
chocolate, and when he grins, you see those two big front
teeth. He has the smooth, lean, muscular limbs of a child for
whom movement is perpetual. You would never guess when he is
sleeping that with that perfectly handsome face and that
perfect 8-year-old body that Quinn has almost no language, that
Quinn will bite and claw people in fits of aggression, which at
times, appear as spontaneous and uncontrollable as a seizure,
and that Quinn, on a bad night, can get along on as little as 3
hours of sleep.
You think you have all the answers until you become a
parent. I did not even know all the questions. The main
question my husband and I have had to address is, what are we
going to do now to help?
We initially decided to use behavior analytic treatment, an
educational technique derived from research on operant
condition. A one-on-one therapist gives the child short and
clear instructions for a desired behavior. For example, Say
``Hi.'' A correct response gets an immediate reward. For
example, the therapist smiles and says, ``Great job.'' An
incorrect response may be ignored or may trigger the therapist
to prompt the child. As recommended, Quinn received 40 hours
each week of one-on-one therapy. Studies at UCLA had shown that
many children had significant improvement with this technique
and replications at three other sites confirmed their findings.
When I say this, it sounds so rational. We were faced with
this devastating diagnosis and we went through the literature
and talked to every expert we could find. We found an
intervention on which there was encouraging evidence, so we
threw ourselves, day and night, into getting and keeping the
therapy in place. I assure you that it did not feel rational at
the time. I had the panic-stricken urgency of a person staring
down the barrel of a gun. My son's brain development, I
believed, depended on me finding the right therapy in time
before we was too old to be helped.
Autism and mercury experts at the University of Rochester
have advised us not to get chelation therapy for Quinn. I was
told that chelation is not recommended even for acute mercury
poisoning. Brain damage done by mercury poisoning is
irreversible. You do not see improvement after chelation.
Finally, I was told that the safety of this intervention is not
known.
My husband and I have tried other interventions: a phenol-
free diet, a gluten-free and casein-free diet, medications
including Ritalin and Prozac, and cranio-sacral massage. We
tried to get secretin and found a place where we could get a
dose or two for $10,000, but by then evidence was accumulating
that it was not effective.
There have been more questions. Because I am a
pediatrician, and particularly because I used to work for the
CDC National Immunization Program, many people have asked me if
MMR causes autism. As you are well aware, two exhaustive
independent reviews have become available on that topic. The
American Academy of Pediatrics, of which I am a fellow, has
made a summary of their review available to all pediatricians.
They report that the available evidence does not support the
hypothesis that MMR vaccine causes autism or associated
disorders. Separate administration of measles, mumps, and
rubella vaccines to children provide no benefit over
administration of the combination MMR vaccine and would result
in delayed or missed immunizations.
The American Academy of Pediatrics is dedicated to the
health, safety, and well-being of children. The AAP has proven
itself to be absolutely dedicated to vaccine safety. They
quickly withdrew their recommendation for rotavirus vaccine at
the first sign of a problem and recommended the move away from
thimerosal-containing vaccines even during the information-
gathering period.
These actions have given me added assurance of their open-
mindedness regarding the MMR-autism hypothesis and have added
weight to their findings.
Similarly, the Institute of Medicine, the supreme court of
medicine, convened the Immunization Safety Review Committee to
address this issue, and they found ``that the evidence favors
rejection of a causal relationship at the population level
between MMR vaccine and ASD.'' The committee felt that the
relationship been MMR and autism would be extremely rare, if it
occurred at all.
The next question is about thimerosal. And we all look
forward to IOM's review of this topic. I am aware of an
interesting recently published report from the University of
Rochester that shows that none of the blood mercury levels
observed in full-term infants studied shortly after vaccination
exceeded the most recently revised lowest level of maternal
blood mercury considered to represent potentially significant
exposure to the developing fetus.
So what are we going to do now to help? Despite intensive
therapy, my son has not been helped dramatically. And that is
why I am here today. I am absolutely certain that we need more
research. I am pleased that IOM was asked to review the
question of MMR and autism, and I am pleased that they will
review the thimerosal question. I am pleased that NIH is
proceeding with the scientific evaluation of alternative and
complementary medicine. I am delighted with the progress made
by the collaborative programs of excellence in autism and I
trust that funding is assured for the future.
I am excited by the creation of the congressional Coalition
for Autism Research and Education and most especially by the
Children's Health Act of 2000. I am encouraged to hear that the
CDC has created a new Center on Birth Defects and Developmental
Disabilities. All this activity is especially heart-warming for
a parent because autism research has been significantly
neglected up to now.
We need good autism epidemiology in the United States to
determine risk factors and true rates. We need basic science
research into the nature and causes of this disorder. And we
need clinical research to determine what works and what does
not, what is safe and what is not.
As we all know, appropriations are the key. A financial
investment now could, in maybe just a few years, prevent
another mother from having to face the questions I have had to
face. There is a motto: ``You can have it fast, good, or cheap,
pick two.'' In autism, research, we cannot afford to go slowly
or have poor quality. That is why parents want Congress to fund
high-quality research at the high level it deserves given the
disorder's frequency, its devastation, and notable past
neglect.
And we need significant research funding that comes with a
commitment to the long term. Scientists are poised on the brink
of success, but it may not come tomorrow. Like the families of
autistic people, Congress has to be in this for the long haul.
How should the autism research agenda be set? Foremost,
scientists should be encouraged to follow the cues of
epidemiology and basic research. Listen to parents carefully,
but do not neglect to follow through based on the leads from
science.
Autistic families need better services--educational
services for the autistic individuals, parent training for
handling autistic offspring through their lifetime, and respite
services that are so essential in coping. Finally, parents need
to see residential care facilities in place that will help with
the question my other child asked me, what is going to happen
to Quinn when you and Daddy die?
The question for this committee and all of us is the same
as the initial question my family faced, what are we going to
do now to help?
[The prepared statement of Dr. Humiston follows:]
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Mr. Burton. Let me just say that I admire your view,
Doctor, that the health agencies are doing a good job. And I
think for the most part they are, but I would like to bring to
your attention that the rotavirus vaccine--the advisory
committee that recommended that--was kind of split. Some of the
people thought there should be more testing done on the
rotavirus vaccine. But the chairman of the committee had
financial interests in the company that manufactured a
rotavirus vaccine.
Dr. Humiston. The chairman was John Motley, who had no
conflicts of interest at all.
Mr. Burton. Let me just tell you that we have already
checked. We looked at the financial disclosure forms. The
chairman----
Dr. Humiston. It could not have been the Chair. He has no--
--
Mr. Burton. Well, there were a number of people on there
who had financial interests in the rotavirus vaccine. And that
vaccine was put on the market. Within a year, we had one child
die and a number of them had serious problems. We are looking
at and have found some financial conflicts of interest among
other people who are in the decisionmaking process.
That is one of the reasons why many people in Congress are
very concerned about things like the report we just received.
And that report was not categorically saying that the MMR
vaccine was not a cause of autism. It did not conclude that, if
you read the whole report.
Let me just ask a couple of questions here.
First of all, does the MMR vaccine, when it is being
produced, does it include in any way in the production mercury?
Do any of you know that?
Dr. Humiston. It does not. MMR does not contain thimerosal.
It contains no preservative because it is a live vaccine.
Mr. Burton. I am asking in the manufacture of it because in
the manufacture, we have been told--and I do not know that it
is true--there was mercury in some of the production of the
vaccine.
But you are saying that categorically, that is not----
Dr. Humiston. No, because it is a live vaccine. The live
vaccines do not need preservatives.
Dr. Segal. I would say that we do not know. I would say
also that in the manufacture of the drug we are working on,
there is mercury in the process and we take pains to remove it
at the end. We think that it is all out.
But I think the answer to your question is that we do not
know. I do not know that----
Mr. Burton. But there is mercury used in the process?
Dr. Segal. I do not know. I do not think anyone here knows.
Mr. Burton. We want to check on that and find out about
that.
Mr. Bradstreet, are you stating that the combination of the
thimerosal-containing vaccine with the MMR vaccine causes
neurologic, immune, and GI problems in susceptible children?
Dr. Bradstreet. I think that would be incomplete, but I am
saying that in part.
I think there are a number of environmental factors that
are skewing the child's immune system toward a predilection
along the autoimmune lines. I think that thimerosal is one of
those issues. The aluminum adjuvants is another issue.
Then the other vaccines I discussed--the Hepatitis B
vaccine and HiB--also are capable, as is pertussis--of pushing
that TH-2 response so that by the time we get to the 15-month
level or so and we give the MMR vaccine, it is the next TH-2
potential responding vaccine that the kids get. For some of the
kids, it is just too much.
However, I have a number of kids who, immediately after the
Hepatitis B vaccine--within days--seem abnormal and never
recover and evolve autistic-like symptoms. I have heard the
same thing after pertussis.
So it is not just MMR by any means, but there is a
significant number--perhaps half of our families--who now claim
they had a perfectly healthy child and within days--10, 14
days, whatever--their child was completely changed following
the vaccine schedule.
That, in and of itself, is not conclusive. But it certainly
causes one to look very, very hard at that subject.
Epidemiology, in and of itself, is not going to give us that
answer.
Mr. Burton. You talked about the mercury. That was in the
Hepatitis B vaccine as well?
Dr. Bradstreet. Yes, as well as in the HiB vaccines. Almost
all the HiB vaccines have mercury in them as well. So those are
multiple sources for mercury.
Mr. Burton. That is exactly what happened with my grandson,
within days after his.
Dr. Bradstreet, are you seeing improvements with the
treating of children to remove mercury? Do these children
appear to be more vulnerable to other toxic metals?
Dr. Bradstreet. I think that something--and I am not sure
what it is at this point in time--has wounded the body's normal
and natural metallic defense. We have a system in the body
designed to prevent environmental toxins like mercury and lead
and other things from being toxins within the body. Many things
protect the body. However, for whatever reason, certain
children seem to be unusually vulnerable to that.
There is abundant data now available that individual
variability at the time of the mercury exposure to thimerosal--
we do not know how susceptible that child is. We do not know
what other sources of mercury he has had, whether it was RhoGAM
or diet or environment. We do not know how much he is going to
get. And we do not know the status of his ability to defend
against that mercury. We kind of cavalierly give it assuming
that because it is below some sort of EPA threshold--although,
with the combination of the multiple vaccines that is not
true--that it is going to be safe.
I think that there is something about certain children that
makes them very vulnerable to mercury.
Mr. Burton. I have some more questions.
Mr. Horn.
Mr. Horn. Thank you, Mr. Chairman.
Dr. Segal, I believe you mentioned RhoGAM, and the content
of thimerosal.
Dr. Segal. That is accurate, yes.
Mr. Horn. What would be the behavioral changes if one used
that consistently?
Dr. Segal. I am not sure I understand that question, but
let me take a stab at it.
The medication is RhoGAM, which would be given to RH
negative mothers to prevent a reaction with children in terms
of attacking their blood cells.
Thimerosal is used as a preservative. It is given to the
women--at this point--while they are still pregnant. The
mercury preservative would be able to cross through the
placenta and get into the developing infant. The theory would
be that it would harm the developing fetus, at which point you
would see neurodevelopmental abnormalities.
Mercury is an accumulative problem. That is, as you
continue to be exposed to mercury, the body struggles with
trying to remove it. When it builds up to some critical level,
which cannot be predicted in the individual child, we have the
potential to see neurodevelopmental problems.
Mr. Horn. So this is nothing to do with Rogaine, which
relates to hair, and so forth? [Laughter.]
Dr. Segal. Not to my knowledge.
Mr. Horn. You have 2 million people across America who will
wonder.
Dr. Segal. I think they can rest comfortably. [Laughter.]
Mr. Horn. Dr. Segal, do you think the genetic component of
this problem may be the inability to these children to clear
toxins and metals from their bodies?
Dr. Segal. I think that is the first step. I think there
are multiple problems that are individually necessary but not
sufficient. I think the first step is a genetic predisposition.
I think that predisposition relates to the ability to detoxify
against environmental insults.
Mr. Horn. Do you agree with the comparison of the symptoms
of autism and the symptoms of mercury toxicity as similar? Do
you see that?
Dr. Segal. I think the parallels are astounding, yes.
Mr. Horn. And that has been a lot of your research?
Dr. Segal. That is correct.
Mr. Horn. So you are speaking from scientific research?
Dr. Segal. That is accurate, yes.
Mr. Horn. Thank you very much for your testimony. I was
very interested in it.
Dr. Schneider, are you seeing children with increased
toxicity to other substances, such as arsenic?
Dr. Schneider. Absolutely. My own children have high levels
of arsenic. After some research, I learned that is because I
live in the State of Arizona where mining has been and still is
occurring and our water supply comes from Colorado where the
same can be said. Gold is mined with cyanide. Copper is minded
with arsenic. It is so prevalent in the Phoenix water that no
one is using Phoenix water. We have to get our water from
Colorado, which really is not much better.
I have a reverse osmosis system in my household, and I
mistakenly thought that removed heavy metals. I found recently
that was not correct. I had to pay $5,000 to put in a water
system which did remove arsenic and mercury from our water
supply.
Mr. Horn. That is the Phoenix water system?
Dr. Schneider. Yes.
Mr. Horn. Do you see that throughout Arizona?
Dr. Schneider. I have not looked throughout Arizona, but
certainly there are metal-toxic children throughout Arizona.
Mr. Horn. We see the same thing in Los Angeles where we
have had various types of industries, small and large, where
the metals just get into the underground water supply. That has
become a major problem. I know EPA has studied this. What
studies have you seen that lead to a different--arsenic as it
goes around--some say you cannot deal with it because it is in
this or that. I just wonder what kind of research you have seen
where it is clear that it is hurting people substantially.
Dr. Schneider. Quite honestly, I do not do that kind of
research and I am not as familiar with it as I intend to be
because I was focusing more on the mercury aspect. But I find
now that mercury is not our only problem. We are exposing our
population to many toxic metals.
Mr. Horn. We understand that typically children with autism
are first diagnosed by a developmental specialist or
psychiatrist and that the physical problems with these children
are not addressed.
What do you think must be done to ensure that these
children receive appropriate medical care?
Dr. Schneider. At our research center, we have initiated a
physician outreach program, which is now in the stages of
developing educational material for physicians, planning
conferences for physician education. The reality is that most
parents diagnose their children and then go to their
pediatrician who tells them that they do not think so. Then
they go back again and eventually get referred to the proper
specialist and have the diagnosis confirmed.
In my own case, our pediatrician is a dear friend of mine
and I have the greatest respect for him, but he did not know
autism when he saw it. And that is very, very typical. We need
to change that because, as many of us know, the earlier the
child is diagnosed and the earlier the intervention is begun,
the better the child's chances of having a partial recovery.
My own children are 8\1/2\ and 9\1/2\ years old now. I
would say the clock is ticking.
Mr. Horn. In some of Chairman Burton's earlier hearings, we
found there were a lot of medical journals of which there are
probably a couple hundred--I have seen them in our library in
Long Beach--that have glowing reports of this or that and they
do not really tell you the effects on it. Do you have some
feelings that the various professional groups and segments of
this and that specialist, and some of their yearly meetings--
they ought to have meetings that relate autism to all of the
things that they might not--they go through medical school and
there is great ignorance there in many ways, just like
nutrition was, which was a simple thing. Doctors ought to know
something about nutrition. Well, doctors ought to know
something about this.
Now, how do we communicate with them where they read it,
and they see it, and it means something?
Dr. Schneider. You are absolutely right because the reality
is that pediatricians or family practitioners were not educated
in the area of autism. Their image of autism is a child rocking
and banging his head on the wall. Many of our children do not
do that, thank goodness, yet still have autism.
So the physician outreach is a very important project for
us. But what we realized when we spoke to the residency
programs in our city is that pediatricians in training right
now--a pediatrician has 4 years of college, 4 years of medical
school, and 3 years of residency--in that training process,
they talk about developmental disabilities for about 1 month,
and autism is only one portion of their focus. So there really
is very little exposure to this area.
If you think about what happens in terms of medical
education after training, it is primarily in the form of
conferences. I am sorry to say that most conferences are
sponsored wholly or in part by pharmaceutical companies. The
message they want to get across has much to do with treatment
of the condition for which they have a drug.
So you have to understand that it is up to the physician to
educate himself or herself after training and to take into
account the sources of the information they are receiving.
Mr. Burton. Thank you, Mr. Horn.
Mr. Horn. Thank you.
Mr. Burton. I will tell you my son-in-law is a doctor. And
many doctors pretty much take at face value the recommendations
and the research done by the CDC and the FDA. I can tell you
that even here on Capitol Hill--like I was talking about the
vaccine we get for the flu--I do not think any doctors up here
even knew that there was mercury or thimerosal in it.
Mr. Blagojevich.
Mr. Blagojevich. Thank you, Mr. Chairman.
Dr. Humiston, our staff has just checked with Merck, the
only licensed manufacturer of the MMR vaccine. The staff was
told--and perhaps you can confirm this--that there is no
mercury in that vaccine. Is that consistent with your
understanding?
Dr. Humiston. Yes. My understanding is that there is no
mercury and there is no mercury in the process of making it. It
is thimerosal-free, as opposed to the vaccines that have
mercury in the process but not actually in the vaccine.
Mr. Blagojevich. Thank you very much.
Thank you, Mr. Chairman.
Mr. Burton. We will check on that.
Dr. Weldon.
Mr. Weldon. Thank you, Mr. Chairman.
I have a question for Dr. Bradstreet.
You have been doing a lot of research--and really any of
you can comment on this--and you have talked to a lot of
researchers. Have you encountered any lack of willingness or
intimidation to research in areas that might suggest that there
are problems with vaccines in terms of its impact on the
careers of researchers or their ability to get funding in the
future? Have you encountered any comments to that effect?
Dr. Bradstreet. Yes. Actually, we work with researchers at
several major university medical schools around the country.
Many of them or their department chairmen have related back to
us that there is significant fear and apprehension about doing
a study that looks into vaccine safety for fear of being
blacklisted by the pharmaceutical industry for future funding
of research. Many pediatric departments or infectious disease
or immunology departments around the country at medical schools
are completely dependent for a vast majority of their research
budget and operating expenses on granting from the vaccine
manufacturing companies. Many of those vaccine manufacturers
make a host of different drugs.
If you look then at the potential liability issue--
determining for example that thimerosal may be harmful to
children--what that means from a liability perspective, a
beginning of life neurologically damaged child that has a life
expectancy similar to yours or mine, 70 or 80 years of care--
that is cataclysmic. So they will go a long way to potentially
suppress research along these lines.
It is something that needs to be addressed and there need
to be independent sources of funding completely apart from the
drug companies.
Mr. Weldon. Have any of the other witnesses encountered
comments to that effect? Or would you rather not comment on
this issue?
Dr. Segal. I would rather not comment on that issue. I
would say, without getting into detail, the answer is yes. We
have encountered that difficulty. But as we are trying to make
in-roads in terms of additional research projects, I feel any
comment I could make would be fragile.
Dr. Humiston. At the University of Rochester, because my
developmental pediatrician is one of the researchers for the
centers of excellence, I am aware of what they do. They are
getting funding to look at vaccine safety issues.
Mr. Weldon. I have a question about the incidence.
The incidence in boys is four times higher than the
incidence in girls. The incidence in the population is
estimated at being--some say as high as 1 in 100--most likely 1
in 500 or somewhere in between, according to a lot of
researchers. But that doesn't that mean that the incidence in
boys is substantially higher? Aren't we talking about it being
somewhere between 1 in 50 and 1 in 250?
Dr. Bradstreet. Just to be specific, we are talking about
prevalence, which is the amount of disease in the population of
children or boys. Incidence would be the new cases that are
coming on-line per population on an annual basis. That is
probably very high as well, although there is much less
incidence research being done as compared to prevalence.
We know that it is very prevalent. A lot of children have
this. If you look at Oregon as an example--and all the
citations are on pages 5 through 8 of my testimony--clearly
Oregon is very conservative. The State is run by a physician.
Mr. Weldon. If I could interrupt you for a second, the
Oregon data you showed was less than 1 in 200. Is that correct?
Dr. Bradstreet. Yes, 1 in 190 in Oregon.
Mr. Weldon. What does that make it in boys?
Dr. Bradstreet. It is probably something like 1 in 50 or 1
in 70 in boys if you factor the four to one difference in
occurrence rate in boys.
Mr. Weldon. Dr. Segal, you kind of made the comment as a
joke, but this issue--I have had CDC officials in my office
talking about whether we have an epidemic or not, and they cite
how the DMS-3 was changed. But you made an excellent insight.
If we are just diagnosing it better, what happened to all the
adults? Is anybody researching that or looking into that?
Dr. Segal. If it is a question of diagnosis, the adults
have to be somewhere. They did not disappear. The problem is
that they are not there. The numbers have gone up. I think that
is the only conclusion we can make.
Mr. Weldon. But nobody has done a research study looking at
adults who are in institutional care, have some kind of
psychiatric disability, who were perhaps previously diagnosed
as mentally retarded, who may have actually had autistic
spectrum disorders. Nobody is looking into that, to your
knowledge?
Dr. Segal. To my knowledge, no one is. I would comment that
Dr. McDougle, when he was at Yale, had a great deal of interest
in adult autistic patients. So he may be able to comment on
that further. He will be in the third panel.
Mr. Weldon. I know I am running out of time. I just have a
question for Dr. Humiston.
You quoted from the IOM study that the committee concludes
that the evidence favors rejection of a causal relationship at
the population level between the MMR vaccine and autistic
spectrum disorder. I fully expected them to say that because if
they did not say that and it got out in the press, then parents
all across America would start rejecting the vaccine and we
could have a huge explosion of measles.
But then they did go on to say in the next section that
they did note that their conclusions did not exclude the
possibility that MMR vaccine could contribute to ASD in a small
number of children because the epidemiologic evidence lacks the
precision to assess rare occurrences.
I assume you agree with that section of the report as well.
Then they further went on to recommend further areas of
research--and they have several areas of research they
recommend--to include to develop targeted investigation of
whether or not measles vaccine strain virus is present in the
intestines of some children with ASD.
Essentially, they are calling for what I had encouraged
them to do when I testified before them, to encourage NIH to
fund the duplication of Dr. Wakefield's and O'Leary's work.
I assume you have seen Dr. Wakefield's micrographs and
slides of inflammatory bowel disease in these kids, and you
have reviewed Dr. O'Leary's PCR research showing the presence
of measles virus particles in the intestines of these kids.
Dr. Humiston. I have not reviewed his micrographs. I am not
a gastroenterologist. I am an emergency medicine pediatrician.
Mr. Weldon. I am an internist, but I have ended up having
to get very familiar with all this.
If you listen to all the press reports, they loaded up at
the beginning of the press report that IOM says this is fine.
Then they go on and--at least the better coverage of what I saw
of all this--to say that further research is recommended. I do
not want to accuse the IOM of talking out of both sides of
their mouth. They were in a very, very delicate situation.
I have some concerns about the way the study was passed
through some of the reviewers, or some of the witnesses who
have had a track record of being critical of this work. But I
think we have a very serious issue here. You cannot refute a
clinical and pathologic report with an epidemiologic study. You
cannot do that. It is bad science. You have to fund an attempt
to duplicate the clinical study and the pathologic study.
Would you agree with that?
Dr. Humiston. I am in agreement that the study should be
replicated. I am in agreement that epidemiology alone does not
refute.
What IOM reviewed was not just simply two or three
articles. It was many.
Mr. Weldon. I know.
Dr. Humiston. And I did have the privilege of being in the
room during the IOM report. So I was privileged to hear about
changes in autistic brains of children in areas where the brain
develops and is used for different things at different times.
So the neuropathologist was describing how this could explain
how we see regression.
There was one researcher there who showed how blood spots
taken on the first day of life had different levels of vaso-
active intestinal protein present in day 1 of children with
autism, different levels than controls. I think IOM took Dr.
Wakefield's hypothesis very seriously, as I think it deserved
to be taken very seriously.
I also do not think that when you say in a light way that
this is what you expected of IOM--I have great respect for
those scientists. They came from many fields. And many of them
did not come from vaccines.
So I think that taking that lightly is a disservice to
those scientists and to the work of people who are moving
forward with genetic explanations.
Mr. Burton. We have to have a vote. We have 6 minutes left
on the clock.
Mr. Weldon. I just want to clarify one thing.
You are accusing me of taking it lightly what they were
doing. I do not like that at all. I consider this report a good
report. I was pleased with the results of this report. But for
them to spotlight and put the focus of public attention on the
serious issues being raised about the safety of this vaccine by
Dr. Wakefield, it is going to cause parents--just like it
happened in England--to quit giving the vaccine. So they were
in a very awkward situation, in my opinion.
I personally believe that there is a problem with this
vaccine. And there is a subset of children who have a genetic
predisposition to having problems with this vaccine. But
further research is needed.
I do not want to be accused of taking their findings
lightly. I consider this basically what they should have done.
They did what was needed.
Mr. Burton. Let me just conclude--and I hope you will come
back for the third panel, Doctor, because I value your input.
Let me just say to you that they did send that report out
for review to people from various pharmaceutical companies, and
there were changes made, as I understand it, or corrections or
perfections done on that report. I want to find out what those
were.
Let me just ask two quick questions.
Does secretin cost $10,000 for two doses? I think my
grandson got secretin and I know it did not cost that.
Dr. Schneider. There certainly are some practitioners who
charge that much. That is absolutely true.
Dr. Bradstreet. Mr. Chairman, $200 to $300 for what used to
be available is no longer available is a fairly common cost to
the physician. Relatively commonly, physicians double the price
of something that they buy. So if they buy a vaccine for $20,
they would like to sell it to the patient for $40. So that is
an outrageous price.
Dr. Schneider. Our regular pediatrician would not give it
us. We were trying to find any source.
Mr. Burton. And my other question is, can chelation remove
mercury from the brain?
Dr. Bradstreet. There is no evidence of that at this point
in time.
Mr. Burton. Anybody else?
Dr. Segal. I agree. There is no evidence one way or the
other. In fact, I spoke with two mercury experts. One suggests
that mercury stays in the brain indefinitely. The other said
that mercury is cleared within 50 or 75 days.
The bottom line is that nobody knows at this point.
Mr. Burton. We need some research on that point as well.
Dr. Segal. Yes, we do.
Mr. Burton. We will dismiss this panel. Thank you very,
very much. We really appreciate it.
We would like to have your documentation and reports in
total, if we can get those, so we can submit those to the
health agencies.
Thank you very much.
We will be back. We will stand in recess to the fall of the
gavel and go to our third panel as soon as we get back. It
should be about 10 minutes.
[Recess.]
Mr. Burton. We have a very large second panel. It is very,
very important, though, that we cover all this territory. There
will be other Members coming back from the floor in a minute.
[Witnesses sworn.]
Mr. Burton. We will start with Dr. McDougle. You are
recognized.
STATEMENTS OF CHRISTOPHER J. MCDOUGLE, M.D., RILEY CHILDREN'S
HOSPITAL, INDIANA UNIVERSITY SCHOOL OF MEDICINE; ANDREW
WAKEFIELD, M.D.; WALTER SPITZER, M.D., FACULTY OF MEDICINE,
MCGILL UNIVERSITY, MONTREAL, CANADA; BOYD E. HALEY, DEPARTMENT
OF CHEMISTRY, UNIVERSITY OF KENTUCKY; DAVID G. AMARAL, MIND
INSTITUTE, UNIVERSITY OF CALIFORNIA, DAVIS; DR. ELIZABETH
MILLER, PUBLIC HEALTH LABORATORY, ENGLAND; AND DR. MICHAEL D.
GERSHON, DEPARTMENT OF ANATOMY AND CELL BIOLOGY, COLUMBIA
UNIVERSITY
Dr. McDougle. Thank you very much, Chairman Burton and
committee members. Thank you for the opportunity to come and
speak with you today.
In addition, I would like to thank you personally for your
recent efforts to assist our work in autism at the Riley
Hospital for Children in Indianapolis. It is very much
appreciated.
I was asked to come today to talk a bit about our current
clinical, educational, and research activities at the Indiana
University School of Medicine. I am currently the chairman of
the Department of Psychiatry as well as the director of the
section of child and adolescent psychiatry and the chief of the
Autism/Pervasive Developmental Disorders Clinic.
I have been doing research and clinical care in the area of
autism for the past 12 years or so. I came to Indiana in 1997,
and at that point wanted to establish a formal autism clinic.
At that time, we had approximately 100 children with a
diagnosis of autism and other pervasive developmental disorders
in our clinic. We brought those children together into a
formalized manner and then began to build a clinical team.
At that time, I was the only child psychiatrist on the team
and we had one clinic coordinator. We soon realized--once we
got the word out that we had a formal clinic--that we needed to
expand our clinical operation significantly.
We currently have an active clinic census of over 500
children. So in 3 years the census within the clinic has gone
from 100 to 500. The disturbing and alarming part of that is
that our waiting lists are out 9 months in advance now to bring
children and families in for a new evaluation. So we have 9
months of people on the waiting list to even begin to get in to
see us. At the same time, we are still trying to provide good
care for the 600 current families within our clinic.
In an effort to meet some of these clinical demands, we
have begun to hire additional faculty. I have added another
full-time child psychiatrist, a nearly full-time behavior
therapist, and a social worker to work with families to provide
resources and help them with a number of the sticky issues they
face.
Despite those additional clinical personnel, the waiting
list persists. So I can certainly say firsthand that we are
working very hard in Indiana. Autism is not rare. And we are
having difficulty keeping up with the pace of personnel,
despite adding additional personnel.
One problem with providing clinical care is that the
reimbursement for such care is very poor. It becomes an issue
as to how you are going to fund additional personnel to care
for the growing population of your clinic when insurance
reimbursement is often nothing or minimal. So that is an issue
that I think needs to be addressed to a greater degree.
With regard to research, I am an expert in the area of
psychopharmacology. I would say I am pretty good at diagnosing
autism and related disorders and treating symptoms of autism
that can become quite problematic. These symptoms--many of
which have not been mentioned yet today--include aggression
toward self, aggression toward others, property destruction,
hyperactivity and inattention, interfering repetitive or
ritualistic behavior, as well as the core disturbance of
autism, which is a disturbance in the ability to relate
appropriately to other people.
And we have a number of medicines we are studying in an
effort to try to reduce some of these symptoms so that the
child may be better able to participate in non-drug treatments,
to be able to sit still and pay attention in speech therapy and
other educational activities. But many times these symptoms I
mentioned are so severe that the child cannot even get into a
school or educational setting to benefit from these alternative
treatments.
I would like to thank the National Institute of Mental
Health. Approximately 3\1/2\ years ago they instituted a
program to develop research units on pediatric
psychopharmacology. They put out an RFA specifically to develop
centers focused on autism. We were fortunate enough to be
chosen as one of those centers in addition to four others
across the country.
We recently completed our first study of a medication
through this program with a medication called Risparidone,
targeted really at some of the more severe symptoms of autism,
including aggression, self-injury, and irritability. This was a
double-blind, placebo-controlled study. We entered 101 children
in adolescence into this study, which will make it by far and
away the largest medication study ever conducted in autism to
date by at least half--twice as large. So the idea of having
multiple centers working together to get a larger sample size
more quickly makes a lot of sense. I would like to see the RUPP
networks continue to be funded.
In addition, we have begun to explore a number of what we
call investigator-initiated studies. When we read the basic
science literature, we get ideas about medicines or compounds
that might be helpful for some of the symptoms of autism. We
then go and try to generate some pilot data that if there is
something to it we then apply for Federal funding. We have
initiated a number of studies with some of those compounds.
The other areas of research in autism to date that I think
are hopefully going to be fruitful include those that have been
successful in investigating disorders in other areas of
medicine over time, and that includes genetics. Certainly there
have been large dollars put into the genetic research of autism
to date without really significant results.
What that tells us is that this is a complex disorder, that
there may be multiple genes involved in autism, and my guess is
that eventually we may find in fact that multiple genes might
be contributing to just certain small populations of autistic
children. So it is going to be very difficult to pin down a
gene or genes for autism, although clearly there is a genetic
basis.
But I focus most of my energy on treating people that
currently have autism. That has been emphasized today, not only
the need to find the cause but to treat those people we already
have with autism. I would like to see more funding put into
treatment--not just drug treatment, but other forms of
treatment--for autism.
The question came up earlier--and Dr. Segal referred it to
me--regarding adults with autism. When I began my work 12 years
ago at Yale University, at the time I was not a child
psychiatrist. Due to various factors, I was not allowed to see
children--maybe for a good reason. But I really wanted to study
autism, so I initiated a clinic for adults with autism, which
was really unheard of at the time.
My colleagues looked at me strangely and said, why would
you want to study adults with autism? I asked them what they
thought happened to children when they grew up. Most people
view autism as a childhood disorder. In fact, it is a
childhood-onset disorder that lasts forever.
Those individuals, in fact, are out there. One of my
moonlighting jobs while I was in Connecticut as a consultant to
the Department of Mental Health--and I actually went to the
State hospital and the ``back wards'' where adults were
hospitalized, and not infrequently could I identify individuals
that had a history consistent with an earlier diagnosis of
autism.
So they are out there, often misdiagnosed with
schizophrenia or other disorders. But I will say that since I
have been in Indiana and am now seeing kids, the ratio of kids
coming to me versus adults is highly skewed in the direction of
newer onset of cases in children. So the adults are out there,
but there are many, many more kids and younger individuals who
are being referred at this point. I have a sense that the
numbers are increasing significantly. Again, I do not know the
reason for that.
Mr. Burton. Can you sum up, Doctor, so we get to some
questions in just a few minutes?
Dr. McDougle. Sure.
I have really touched on our clinical and research efforts.
The other thing I would like to highlight would be our efforts
in education. That is something else that has been brought up
today.
Pediatricians and family practitioners are not adequately
educated about autism. I never heard about autism in medical
school at all and first learned of it during my second year of
psychiatric residency. So what we are doing within our clinic
is having all the medical students in fact rotate through our
clinic with us so that--we are the second largest medical
school in the country--a large number of students are at least
now seeing individuals with autism and being exposed to those
treatments. I think that is important.
Mr. Burton. Very good. I think we will come back and talk
with you. You are doing a good job there and I am happy to work
with you.
Dr. McDougle. Thank you.
Mr. Burton. Dr. Wakefield.
Dr. Wakefield. Thank you, Mr. Chairman. It is a great
pleasure to be back here and provide you with an update and
recommendations following last year's meeting.
[Slide presentation.]
Dr. Wakefield. Let me just give you my terms of reference,
and that is that we are dealing with a subset of children on
the autistic spectrum. What I am going to present to you is
based upon the scientific data. It is not fragmented. It is
based upon a logical, hypothesis-testing framework. It is not
anti-vaccine. However, it is not based upon assumptions of
safety or coincidence. It is not an isolated opinion. It is the
opinion of a growing number of physicians, as you have heard
today, and it is based on conventional methods of listening to
the patients and parents and the new-kid-on-the-block in this
context is public health.
Let's go to the clinical history, which I will just briefly
review, and that is of normal early development, of
developmental regression, and the majority of parents cite the
contemporaneous regression of their child following MMR
vaccination. There is onset of associated neurological and
gastrointestinal symptoms. The children also suffer recurrent
infections.
You have heard that bowel symptoms are common in autistic
spectrum disorder children, particularly in the United States,
between 47 and 80 percent. So these findings may apply to a
large proportion of the pediatric population with autism. The
GI system are often masked by behavioral problems and if a
history is not taken by an expert in gastroenterology, then
these can be missed.
The question for the physician is, do these symptoms in
these children reflect underlying intestinal disease? The
medical profession hitherto have said, no, they do not. The
answer is, yes, they do.
We have now published several papers, peer-reviewed papers.
The first in the Lancet in 1988 and then in the American
Journal of Gastroenterology in 2000, which was met with a very
favorable commentary from the editor. And just a few weeks ago
we published on the characteristics of this bowel disease in
these children, comparing it with classical inflammatory bowel
diseases, Crohn's Disease and enterocolitis, and normal
controls, peer-reviewed and published data. We are presenting
next week in Europe the discovery of not only a disease in the
large intestine, but a disease in the small intestine as well.
And you have heard a great deal about autoimmunity. The
disease in the intestine of these children is an autoimmune
disease. There are antibodies in the blood of these children
that bind to the lining of the bowel and seem to be part of an
inflammatory reaction.
The key features are of developmental regression, swelling
of the lymph glands in the bowel--this is consistent with a
viral cause. The enterocolitis and inflammation throughout the
gut is consistent with a viral cause. And the immunodeficiency
we see in these children is consistent with a viral cause.
The important thing, though, Mr. Chairman, is that parents
were right. The medical profession was wrong.
This issue of coincidence--and this is an important one--a
child receives the MMR vaccine in the second year of life, and
this is when the first signs of autism are noted. Bear in mind
that we are dealing with regressive autism in these children,
not of classical autism where the child is not right from the
beginning. But coincidence is a situation you arrive at by due
scientific and clinical investigation. It is not something that
you assume from the outset. That is not good medicine; it is
not bad medicine; it is nothing at all.
We will gain nothing from looking at children who had a
single dose. But can we gain something from looking at children
who had more than one dose? It is very important to raise this
issue because this came up at the Institute of Medicine's
review.
Here we have a group of children, each time line
representing one child, and these children received not one
dose but two doses of the MMR vaccine. What we see is that in
many cases the red square and circle represent their
contemporaneous regression into autism and subsequent
deterioration. The green square and circle represent their
first and second exposures to the vaccine.
What we see in many of these children is a double-hit
phenomenon. They regress after the first dose, and then they
regress further after the second dose. Let me give you an
example, that is the child with the larger icons.
This child did not receive his first MMR vaccine until he
was 4 years 3 months of age. This is not just recognition. He
then deteriorated into autism. Clearly, this was not even
autism by definition, a disintegrative disorder. He then
received his second dose at 9 years of age and disintegrated
catastrophically. He became incontinent, his feces and urine,
and he lost all his residual skills. This is not coincidence.
The reason I am concerned about this, Mr. Chairman, is that
at the IOM's review there was considerable concern and anxiety
raised over these double-hit issues, these double-hit cases.
The data were requested from me to be discussed in the closed
session of the IOM, such were the concerns of the committee
members. However, they find little or no mention whatsoever in
the IOM's report.
The IOM's report gives one and a half pages coverage to Dr.
Fombonne, who was one of the co-presenters. It was sent to him
for review subsequently so that he could make amendments. It
was not sent to me. It was also sent for review--as you pointed
out--to people who have a clear conflict of interest in the
vaccine arena.
The reason it was not sent to me, I am certain, Mr.
Chairman, is that these cases were not included. This analysis
was not included. And that gives me great cause of concern.
Let me read you a comment from the IOM's report. ``However,
well-documented reports of similar outcomes in response to an
initial exposure to a vaccine and a repeat exposure to the same
vaccine, referred to as challenge-rechallenge, would constitute
strong evidence of an association.'' When we look at those, you
see them. Those represent strong evidence of an association.
They are well worked-up and well-characterized cases.
So the question is, is the virus present in the diseased
intestine? These data were presented at the Cold Spring Harbor
meeting earlier this year, and they were overseen by experts
from the National Institutes of Health.
Is the virus present in the gut? Yes, it is. The viral gene
and the protein are present.
Where is it located? It is located in the specific cells
that we would recognize if it were the cause of this disease.
How much is there? It is certainly a low-level infection.
Can we confirm the presence of the virus with different
technologies? Yes. We have now applied 10 different
technologies to this.
Does the presence of the virus distinguish these children
with autism from controls? It is present in 93 percent of the
children with autism and 11 percent of controls.
And can it be confirmed in independent laboratories?
Bearing in mind that Professor O'Leary's laboratory was
completely independent from mine initially, these further
studies are underway, and the answer provisionally is yes.
The question we have now, Mr. Chairman, is, what is doing
there? We are not saying it is the cause of this regressive
autism, but the question is, what is it doing there? That is
the next phase of our logical progression.
What is the link between the gut and the brain? We do not
know, but it certainly is biologically plausible that one
exists. It may be that it is an autoimmune process shared by
the gut and the brain, or it may be that there are toxic
contents of the gut that are getting through and hitting the
brain in a situation similar to that which we see in patients
with chronic liver disease.
Here is a child whose only treatments have been to the gut.
He is an autistic child whose only treatments have been diet
and control of his gastrointestinal inflammation. You can see
that by solely treating the gut there is a demonstrable
improvement.
What about the shortcomings in epidemiology? In short, Mr.
Chairman, they have tested the wrong hypothesis. My colleagues
and I have not proposed any hypothesis thus far that can be
tested by epidemiology. We are still in the process of defining
the parameters of this disease. In particular, we are concerned
with what makes a child potentially vulnerable to a subsequent
adverse outcome to an MMR vaccine. What sets the child up to
then respond adversely to the vaccine?
What I have done is spent the last 3 years traveling the
world and interviewing patients in our own clinic to try and
establish from the clinical histories what those vulnerability
factors might be. When we look, we see that there is a strong
family history of autoimmune disease, particularly on the
mother's side--of diabetes, thyroid disease, or Crohn's
Disease, for example--that the child receives the vaccine in
the presence of an infection or in the presence of recent or
current antibiotic use, that the child has preexisting
allergies, particularly food and milk allergies, and that the
child receives many vaccines at the same time.
These are consistent elements that have emerged in the
clinical histories that I now believe may represent
vulnerability factors.
So let's look at what the data show. The hypothesis that
has been tested and put down to me--which has nothing to do
with me, whatsoever--is that if this is related to MMR vaccine,
then at the point of introduction of the vaccine there should
have been a step-up in the numbers that should have levelled
out as the vaccine uptake was saturated.
Is that a reasonable hypothesis? Can we assume that the
background susceptibility of the pediatric population has
remained constant? No, I do not. I do not think we can do that.
What we actually see is an increasing incidence.
The time trend analysis for autism in the United Kingdom
and California have confirmed the rise. The data are entirely
consistent with an increasing vulnerability of infants to
adverse reaction to an MMR vaccine. They are certainly
consistent with the clinical histories of affected children.
And again, I am not saying that this in any way proves
causation. What I am saying is that we will gain insight into
this disease from taking appropriate clinical histories and
investigating and set up our epidemiologic hypothesis based
upon that. Now we have a hypothesis that can be tested.
So in conclusion, Mr. Chairman, there is a group of
children whose autism is associated with developmental
regression, immunological abnormalities, intestinal disease,
persistence of measles virus infection in the intestine, and
onset following MMR vaccination. What I would recommend is that
there be a high-level strategic meeting that is formed and a
working group formed under the American Gastroenterological
Association to investigate this specific group of children with
the aim of providing appropriate and necessary clinical care
for these children.
That is an absolute priority. The medical profession has
let them down very, very badly thus far. And a research
strategy needs to be defined by this group in order to
understand this disease.
There needs to be immediate institution of active
surveillance for vaccine-related adverse events. Passive
surveillance has known to have failed. I believe that
monovalent vaccines should be made available. This should be an
issue of parental choice. I think it should be a priority that
we identify those vulnerability factors--for example, a child
who might be on antibiotics--and exclude them from vaccination
until they have improved. We also need a policy for identifying
and protecting susceptible children, and most importantly
thereafter, informed choice.
It is ultimately a pro-vaccine argument, Mr. Chairman. If
we have the ability with a single vaccine to prevent not only
the acute disease, but this concurrent exposure, then we have
the ability to protect children both against measles, mumps,
rubella, and against this devastating consequence.
Thank you.
[The prepared statement of Dr. Wakefield follows:]
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Mr. Burton. Thank you, Dr. Wakefield.
Do we have your entire report?
Dr. Wakefield. Yes, Mr. Chairman.
Mr. Burton. We will submitting these reports to the health
agencies of this country and we will get a response from them
after they review the reports.
Dr. Spitzer.
Dr. Spitzer. Thank you, Mr. Chairman.
I would like to ask with respect that if I need to be
cutoff--because there has been a lot of work done since I was
here at this committee last year--that I be allowed at least to
share with you what is in the future, the research that has
been planned, some of it that has been called for, and which is
going to be undertaken by an intercontinental group in nine
countries and three continents to deal with some of the issues
because this is the first time it has become public--and
appropriately so--because 1 year ago, here in this room, I
decided to commit the rest of my epidemiologic career to
exploring these issues, if nothing else, out of admiration for
the families.
Mr. Burton. We will allow you a little extra time. We have
the other speakers. Because of time constraints, we have a
little bit of a problem. But any additional information you
have, you may rest assured will be put in the record and we
will pass it on.
Dr. Spitzer. I will go as quickly as possible, particularly
on those issues that are not specifically future-oriented.
The kind of research Dr. Wakefield does, with which I am
familiar as much by the literature on an arms-length basis, is
characteristic of laboratory and of clinical research which
asks the question, can it happen? Epidemiology asks the
question, does it happen? And then seeks answers in that
direction.
The vast majority of the literature--and I have looked at
pretty much everything the IOM looked at in the last 15 months
on epidemiology--is inconclusive or uninterpretable answers. We
are trying to remedy that, and I will explain why in questions
or otherwise.
[Slide presentation.]
Dr. Spitzer. My perspectives are those of a professor of
epidemiology and of public health medicine. I believe in
immunization as the pillar of public health, but this does not
mean that each new product can be exonerated from very careful
evaluation, not just of effectiveness but of safety.
I have no sponsorship. The first time I have had coverage
of my travel expenses was today. I work for no one. This is an
initiative done without sponsorship and as neutral as I think
can be attained normally. And I have no family members in the
nuclear family or extended family with autism. That is not the
motivation for my involvement, although that is a noble
involvement.
Autism is an outcome--with very great respect for parents
and families of children--that is as serious as death. It could
not be less significant if I were involved in a mortality study
resulting from MMR. The big differences are that the families
of autistic children cannot grieve. It is their love, their
commitment, and their undying optimism that masks the severity
of autism. It is very important. It is part of the reason I
made a commitment to the strategy for the future of autistic
research.
The Institute of Medicine in a sense agreed. It said the
disorders are incurable, permanent diseases that result in a
serious developmental problem in children.
Incidentally, I was only able to get the executive summary.
I came from overseas last night to be here. Where I was, I
could not get the full report, so I can only quote the summary.
If asked, I shall do that later.
I decided, having finished a review of much of the
literature and the research literature on March 1st,
approximately, when I submitted my paper to appear this month,
that one has to really worry about autism based on the
epidemiologic literature. And I will summarize it quickly.
There is no evidence epidemiologically one way or the other
that either rules in or rules out the problem.
A few days later, I was pleased to read the briefing
document of Dr. Soto and his colleagues to the Institute of
Medicine Committee, which reached pretty much the same
conclusion--differences in words and emphasis--but pretty much
the same. You cannot rule it in or rule it out.
Yesterday or the night before last, I saw that executive
summary. You could interpret it the same way, but the wording
and emphasis and what got to the press--the public relations
version, if you wish--was that immunization is widely regarded
as one of the world's most effective tools for protecting the
public health and the evidence favors rejection.
If they are 48-52 percent, I am 52-48 percent. It is in the
other direction. There has been no research that predicts the
validity and interpretation of Dr. Wakefield's research, with
which I have had nothing to do so far. Until that is set aside,
I could not make that statement, although we are within
percentage points, probably, of the verdict looking at the same
literature.
There is a great deal found in the report that alludes to
causation. In biological population science, you have to
demonstrate association before you get to causation. Normally,
unless the results are very dramatic, you have to invoke the
laboratory and the clinical science at the same time as the
population science to reach those kinds of conclusions
following criteria such as the Bradford Hill criteria, much as
the surgeon general did with smoking of cigarettes 30 years ago
or so.
So we have not gotten to association yet. None of the
studies have gotten there, and certainly--say, the Taylor
Study--cannot refute or confirm association, certainly not
causation. That study mandated in the United Kingdom just does
not prove anything. It is a preparatory, preliminary,
hypothesis-generating study, not a hypothesis-testing study.
And that is where we need to go.
These are the headings--I will go over them very quickly,
Mr. Chairman--the issue of the epidemic of autism, natural
history of autism--I will let you read them for a minute.
Speaking as an epidemiologist, there is an epidemic. It is
not refutable on the evidence that is there. I am saying it,
even though the great majority--except for one or two studies--
they are all prevalence studies. A prevalence study is
inexpensive and that is why one leans in that direction with
the meek resources that are given for this kind of research.
You need incidence to clearly demonstrate or refute an
epidemic.
And the one peer-reviewed published study that did
incidence--which is a case study out of the Boston
Collaborative Surveillance Unit at Boston University, based on
the British data base--it is an incidence study and it shows an
epidemic. It is a seven-fold increase.
In California, you reported yourself, Mr. Chairman, that
there are 700 new cases--which is incidence--in the past 3
months. Compared to the same seasonally adjusted period of 3
months 7 years ago, that is a 404 percent increase. That is an
epidemic.
In Ireland, just the day before yesterday, there is a
three-fold increase in prevalence done in the last few months.
And in Cambridge University, a study showed a 10-fold increase
in prevalence. These are numbers that are not the basis upon
which you question an epidemic. We have an epidemic of autism
and I assert that, as an epidemiologist, with confidence.
There is a widespread assumption that the autistic symptoms
typically do not emerge until the child's second year, about
the same time that MMR is first administered, a sensible
observation made in the executive summary of the IOM. And you,
Mr. Chairman, in your introductory comments asked for the
science about all this.
I have been working pro bono with the autistic families in
the United Kingdom, who are challenging Merck, Smith-Kline, and
others about the possible association. In documents I read of
the attorneys of those companies, the statement was that 55
cases of autism were reported worldwide in the last 20 years of
children with autism.
But I said, wait a minute. There are 505 cases in this list
here. Where do they get that? Apparently, they are reported on
the wrong color of paper to the yellow card system, so it does
not make it into the official statistics.
So I decided that we should do an observational exercise--I
barely call it a study--abstracting each of the medical records
of these children and having some summaries to help us
understand what is going on. We did it. I had an
interdisciplinary team do this natural history of autism on a
self-selected sample. I admit that. This is not representative
of anything. We did not even do statistical tests for that
reason.
The children had to be less than 15. They had to be free of
symptoms not only before MMR but for the first 30 days after to
bias it against us. All symptoms, signs, and diagnosis had to
be in writing by a health professional, not just casual
reporting--which is meaningful, but nevertheless difficult to
validate.
We ended up with 493 medical records that could be used. I
was sort of sobered. I entered a room that was full floor to
ceiling and wall to wall with records. There was not enough
space to work, but we did it anyhow. The average width of a
chart was three volumes totaling more than 10 inches. That is
what we were looking at.
This was looked at independently by the professor of family
medicine of McGill, by a clinical psychologist from the
University of Glasgow, by myself as an epidemiologist, and we
had research assistants helping us with the tasks. It was a
descriptive analyses only, as I said. I am reporting it for the
first time. We met last Friday for the final analysis. We may
end up by one-half percent because I questioned three records,
which are being checked on now. That is what we were doing last
Friday and we are writing the paper now, which should be sent
in a week or so.
So there you see 493 medical records. The numbers there for
exclusion, the 372 eligible subjects--most of the ineligibility
was that they had symptoms early on and we wanted to bias it
against us. We had 70 percent of those cases as classic autism;
7 percent were atypical autism; aspergoes were 8 percent. Of
those cases, 40 percent were regressive, 40 percent were
failure to develop, and 9 percent were both.
But most importantly--and that is with reference to the
evidence you were looking for--this is not good scientific
evidence, but it is a start--if you see there, the median years
from receiving the first dose to making the diagnosis was 2.6
years. That means that half the cases were 2.6 and greater. And
there was great variation.
If you look at average, which is a bit higher, it is 3.2.
But the median is more accurate because of the distribution.
And the range is from 0.5 to 11.9 years of delay. The
correlation does not even exist, the date of vaccination and
the onset of this category of diseases.
I would just like to allude to this, Mr. Chairman. I have
been looking for 17 months for studies with scientific
admissibility that are adequate pharmacological-epidemiologic
evidence of safety, which you would need when a concern has
arisen in the community about safety of a particular drug. I
have not found any. I have not found it. A proper study of
safety under the current conditions, given the frequency of the
disorder, would require about 450,000 children. I went through
that with statisticians at Cambridge. And that has never been
done.
And the ``safety studies'' published are of scores of
patients. That is a type of sample size which is simply
inappropriate, insufficient, and not a scientific way to look
at the safety of a drug. I am astonished that the authorities
in the United Kingdom, the United States, and my country of
Canada are not requiring it the same way they have required us
to do it for all contraceptives, for the right reasons.
The problem is incorrect length of followup as much as
anything in these cases. For instance, the Medical Research
Council report widely cited in the United Kingdom as setting
aside the concern followed an unrepresentative subsample of the
sample of children I looked at for 3 to 6 weeks when the range
is from 0.5 years to 11.8 years. The study is simply not valid
for that reason alone and cannot be invoked to demonstrate
safety or the lack of a need for concern.
There is no problem if you do not look. The companies know
that. Those of an opinion that there is no association say that
epidemiologists have shown no evidence. Of course, they have.
And they have all been small studies. I call them phyto studies
to my students. Phyto means arenal products in the ocean. It
doesn't make any difference in the levels in your
understanding.
Nobody has looked. And the cost of looking is that of
millions of dollars. Is that OK? Yes, it is OK. Look at the
millions of dollars of profits. One way of pretending you are
looking but not looking is by under-powering the studies. They
are not powered sufficiently high to be able to deal with the
no-difference issue leading you potentially to what we call a
type two error statistically.
I will just tell you--and it is in the written record--the
Finnish study reported widely by the press in Britain--much
like likely the IOM reports will be somewhat misrepresented--
does not in any way demonstrate safety or lack of it because it
is a passive surveillance study designed for other purposes and
then reanalyzed for another reason. I give a page and a half of
reasons why that study just does not mean anything one way or
the other. It is in the written record, Mr. Chairman.
Research priorities--I will list them quickly and I will
end up with the study.
Ongoing research in laboratory and the clinic--I will not
say any more. A lot has been said about treatment, but I would
add a word that I hardly ever hear and that is about
palliation. The families need treatment as much as the
children, and palliative strategies need to be undertaken. I am
sure my clinical colleagues couldn't agree more with that. But
it does not get priority in potential focus of support.
Correctly designed safety studies. Correctly designed
incidence studies. And case-controlled studies.
This past Saturday and Sunday, we met at Heathrow Airport,
representatives from six countries out of nine possible
candidates, to decide go/no-go on a major intercontinental
study. The IOM said the committee does propose targeted
research efforts and more rigorous data-gathering procedures.
Much of the problem in existing research is that you are going
into data that were created for a purpose other than exploring
that hypothesis. That is a lot of the problem. This is going to
get around that.
Mr. Burton. Doctor, are you about to wrap up?
Dr. Spitzer. I need 3 more minutes, or less, if I can.
We reached a ``go'' decision on Sunday, a few days ago. We
have been working on it since. I am going back to it.
We are going to explore risk factors other than MMR as well
because there is no point going in 5 years and then deciding
that we should have looked at something else. We are going to
try to avoid that.
The candidate countries are on the slide, nine countries.
Why so many countries?
In England, Canada, Denmark, and the United States there is
such an overwhelming coverage that obtaining control is almost
impossible. You have to have control. The contestants of
clinical science and epidemiology and laboratory science as
well is comparison. Without comparison, you have generation of
hypothesis in the main, very seldom testing of a hypothesis.
You ask in epidemiology, how is your spouse? And you will
probably hear something like, compared to whom? [Laughter.]
You have to have comparison, and that is why we are
proposing a case-controlled study, and to do much of it in-
country. Poland only has 35 percent coverage today. The rest is
univalent. The same with Argentina and the same with France.
Selected features of the study--quickly--3,500 cases and
7,000 unaffected controls. Exposure risk factors: MMR, mercury,
other vaccination, childhood diseases, genetic factors, not to
be exhaustive but as examples. The outcome is the entire
spectrum of autistic disorders.
Why 3,500 cases? Because, as has been said by many
already--and I am pleasantly surprised--we will likely find the
problem in a subset. It is a multifactorial problem, almost
certainly everyone seems to agree. But we do not know what that
subset is in advance.
I would propose that a subset of less than 10 percent--it
is either not discoverable or not as important. So we are
making 10 percent the threshold. That gives you 350 cases and
the corresponding control that may give us important answers.
Finally, it is investigator-initiated. We are not
responding to any request for proposal, therefore we have to
create the protocol and then ``sell it'' to objective,
independent organizations. The cost is estimated to be $17
million to $21 million over 5 years, $125,000 in the first
year.
Is that a lot? It is the equivalent to the annual cost of
care and support of 0.3 percent of autistic children in the
United States alone. We have only methodological support from
the United States so far. We have support from most of the
other countries. We will do it. We would like to work with the
United States. We do not need the United States or the United
Kingdom, for that matter. We hope we can push ahead with this
and look for some of the answers that are being called for.
I apologize for the delay. Thank you for your attention.
Mr. Burton. Thank you, Dr. Spitzer. We will take your whole
program and submit that, along with the others, to HHS and ask
them to take a hard look at that.
Dr. Haley.
Dr. Haley. I am probably one of the few people here who
does not treat patients. I am a research scientist and I work
in a lab.
I was asked some time ago to look and go to the bottom
line. Are the vaccine mixtures that we are placing in the
children toxic? If they are going to have an effect on autism
or any disease or any neurological disorder, there is a good
possibility, if it comes from the chemical level, that vaccines
have to show some toxicity at the molecular level.
We did test vaccines, and I will make this very short
because I know we are in a hurry.
We compared the vaccines with and without thimerosal from
the same source, the same type of vaccine, and those with
thimerosal present were remarkably much more toxic--over 10-
fold to 100-fold more toxic than those without thimerosal.
There was one outstanding exception, and that was the MMR
vaccine. The MMR vaccine was as toxic as the vaccines with
thimerosal, but there is no thimerosal in the MMR. We measured
mercury levels, and I think the thimerosal is not there, but we
would want to do a lot more numbers of vaccines.
But there is something in the MMR vaccine that does inhibit
the enzymes and the brain protein systems that we have very
dramatically. I do not know what it is.
I would point out also that the toxicity is thimerosal in a
vaccine mixture. In our studies, we looked at combined
toxicities because we are not rats living in a pristine cage.
Aluminum is a neurotoxin, formaldehyde is neurotoxic, and you
throw that in with thimerosal, which breaks down to ethyl
mercury, a well-known toxin. You do not know what you will get
without doing studies. I have looked hard and cannot find them.
I am surprised they were not done, but not totally. This is
just something we do not know the answer to.
We do know that ethyl mercury is very, very toxic. Of the
studies you can read about, of the three children that have
been intoxicated that I have found--they all died with 1
microgram per ml levels. That is considerably below what they
would do, but you just do not hit a point and then die. You
start a linear progression of health effects.
The other thing, when we talk about the level of mercury
that is toxic, you cannot compare mercury to ethyl mercury to
dimethyl mercury. They are different compounds. Ethyl mercury,
methyl mercury, and especially dimethyl mercury are much more
toxic than an equivalent amount of mercury on the atom or mole
basis. So you cannot compare them.
I would also point out that the reason mercury does not
kill us immediately is that a lot of it depends on our health.
We all live at a level where we have reducing equivalents this
high when we are 20 years old. We are full of spit and vinegar.
And the mercury level is down here and we are handling it real
well. As we age, the level of glutathione, metallothione, and
other proteins that we synthesize in our bodies--because the
energy level drops down--gets to the point where we are getting
more balanced. When we get too old or too unhealthy, then we
pass this. Then the mercury can take over and start having the
effect of damaging the healthy proteins, the proteins we really
need in the body.
I would also point out that this level can drop
precipitously if you have a viral, bacterial, or fungal
infection. It will drop dramatically because it is fighting to
take care of the oxidants because the molecule that removes
mercury from our body is also the molecule that takes care of
the reactive oxygen species, the normal aging products, and the
materials we call oxidating stress products.
I am surprised, when I understand the data that they are
presenting here--we know certain children are born that are
autistic. These vaccines need to be cleaned up because even if
they did not cause it, who would want to give ethyl mercury to
a child that is destined to get autism? It is a very poor idea.
You really need to clean the vaccines up. I cannot imagine why
they did not take the vaccine mixture and test it, on the very
base level in a test tube against a bank of enzymes or against
a brain homogenate to see whether or not they were injecting
toxicants into these children. It is very clear that has
happened.
I would also point out that we have a problem with combined
toxicities. People that smoke are heavy in cadmium. And cadmium
and mercury, if you combine them together in a test tube and
test system against tubulin--which is probably the first
protein affected in Alzheimer's Disease--that you can have a
non-toxic level of mercury, a non-toxic level of cadmium, and
you add those two together and you will get over 50 to 60
percent toxicity on a comparative basis.
Combined toxicities and the multiplicity of the events that
are caused by mercury--mercury is somewhat similar to alcohol
in that when different people get exposed to it they behave
differently--so it is very difficult when you want to look just
at someone who is an autistic. To me, that is a name and it is
a tantology. Autistics do this. And yet, I say, do all
autistics do that? No. Then there is a difference. They are not
the same. You have to look at them differently. So we have a
very confused issue here that I think we need to look at.
I would also point out that in the vaccine issued, the one
thing that really makes the vaccines toxic to infants--you are
giving the same shot to an infant that you give to a 180-pound
soldier. Infants do not have bilary transport. They do not make
bile when they are first born and for some time after that. The
bilary transport system is how the body removes mercury from
the system. Babies cannot do that. So it is the equivalent of
drinking alcohol and not being able to metabolize it. It builds
up. It would stay there and be much more damaging to an infant
than to someone who is an adult who had the ability to rid the
body of the mercury.
Aluminum is removed by the renal system. Infants have an
immature renal system. They cannot handle heavy metals and get
rid of them as fast as we can. If you give them multiple shots
with high levels of mercury, I do not know how well they handle
it. I have not been able to find any data where this has been
tested. So the mercury and aluminum levels would buildup in
these infants if they had multiple shots before they got to the
point where their bilary and renal systems were totally mature.
The aspect of genetic factors--I was in New Zealand I
talked to a doctor by the name of Mike Godfrey. He is a friend
of mine and he and I have talked a lot about Alzheimer's
Disease and the involvement of mercury. Johns Hopkins
University showed several years ago that there is a risk
factor, a gene called APO-E protein. There are three copies,
two, three, and four. Two is protective against Alzheimer's
Disease; four puts you at high risk for the disease.
If you look at the chemistry of the APO-E proteins, this
can be reflected in the fact that it is a housekeeping protein
that clears the brain of waste materials. If you have APO-E2,
you can carry out two atoms of mercury for every atom of APO-E
that goes out. If you have APO-E4, you can carry out none.
He took this and looked at autistic children. When he did
the screen of autistic children, there was a huge preponderance
of them that had APO-E4, indicating that there is a genetic
risk factor which deserves further study. And it does implicate
that the inability to detoxify the cerebral spinal fluid may be
at least part of the neurological aspect of this disease. I am
not a physician, so I do not go there to make answers about
that.
I have also been in a fight with the pro-dental amalgam
people for many years, as I did research about 10 years showing
that mercury dramatically inhibited the same enzymes that are
dramatically inhibited in an AD brain. And everyone says there
is not enough mercury there to do it. Recently--and it is in
the report I did--they have found that studies using neurons
and culture, that levels of mercury approximately 100 to 1,000-
fold less than you have in your brain, when you place it with
neurons in culture will cause the formation of the two
diagnostic hallmarks of Alzheimer's Disease.
I went to NIH and screened the grants they fund. We found
one where they are funding the ability to make a better amalgam
that would leave less mercury because there was some concern
about the mercury being released, which, according to the ADA
is a totally safe level. But there are no grants looking at the
effects of low-level mercury exposures to Americans. But we are
placing grams in our mouth and micro grams in our vaccinations.
I cannot say, nor would I say, that vaccinations cause
autism. However, if the data holds up that I have been seeing
with the relationship, I think it is an awfully good suspect,
at least one of the co-factors that might aid in the onset of
this disease. So I would really recommend and encourage you to
put some pressure on NIH to look at the contribution of
different forms of mercury we put in our medicines and in our
dentistry to see what effect they have on the neurological
health of Americans, especially autistics.
Thank you.
[The prepared statement of Dr. Haley follows:]
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Mr. Burton. Thank you, Dr. Haley.
You may rest assured that we are going to put as much
information before them and--if you want to call it pressure--
pressure them as much as possible to research all of this.
Dr. Amaral.
Dr. Amaral. Mr. Chairman and members, my name is David
Amaral and I am a professor of psychiatry and neuroscience at
the University of California, Davis.
The last 3 years, it has been my great privilege to be the
research director of a new clinical research experiment called
the MIND Institute. MIND stands for Medical Investigation of
Neurodevelopmental Disorders. I deliberately referred to the
Institute as an experiment because of the unique way in which
it came into being, the unique way in which it governs its
research, clinical, and educational programs, and the unique
focus on understanding the biological basis of autism and other
neurodevelopmental disorders in order to discover treatments
and ultimately cures.
Historically, parents of children with autism have been
given little hope and frequently advised to institutionalize
their child and move on with their lives. This option was
unacceptable to four Sacramento-area fathers, all of whom had
sons diagnosed with autism in the 1990's. Chuck Gardner, a
general contractor, Rick Hayes, an investment management, Rick
Rollens, former secretary of the California State Senate, and
Lou Vismara, a cardiologist, joined forces to create the
concept of developing a world-class research and treatment
center devoted to understanding the biology of autism in order
to find treatments for theirs and other's children.
These four dads approached the UC Davis health system with
the idea of forging a unique partnership between a University
medical center and parents of autistic children to develop an
institute where families could bring their children for state-
of-the-art one-stop diagnosis. Those children diagnosed with
autism or other neurodevelopmental disorders would then become
subjects for multidisciplinary research aimed at understanding
the causes and medical ramifications of their disorders. Once
the biology of autism was better understood, then the clinic
would become the proving ground for new treatments that would
be developed based on the new research findings.
The MIND Institute research program, since that time, has
followed a number of parallel paths of development. It is
important to point out that the Research Committee, which is
charged with all decisions about research direction at the
Institute, is made up equally of parents and senior scientists
at UC Davis. The committee has agreed that the prime directives
of MIND Institute research are to remain open to all
possibilities of causality, to carry out rigorous research in a
collaborative multi-disciplinary fashion, to carry out
innovative and even highly risky research if there are
potentially large payoffs, and to try and determine the
critical path to understanding the biology of autism in order
to develop treatments as quickly as possible.
The MIND Institute research program currently has four
components. It has a UC Davis intermural program, and we are
attempting to develop a critical mass of researchers and
facilities at UC Davis in order to carry out state-of-the-art
multi-disciplinary research on autism and other
neurodevelopmental disorders.
It is clear that certain forms of research and therapy will
only be accomplished when an intimate relationship is
established between the clinic and basic science. This is
really the guiding vision of the MIND Institute.
We have an investigator-initiated grant program. It is
important to note that more than half of all the research funds
allocated to the MIND Institute have actually been distributed
to researchers at other UC campuses and other research
facilities internationally to carry out research on autism and
neurodevelopmental disorders. This extramural program is
guided, again, by the parent-oriented philosophy that it is
more important to get the critical research accomplished
quickly than get the credit for accomplishing it at a
particular institution.
We also have targeted research initiatives. Funds have been
allocated to carry out research in areas that are currently
underrepresented or in need of immediate attention. The MIND
Institute, for example, has launched a nationwide effort to
investigate the potential relationship between vaccines and
autism. I will say more about that in a moment.
Finally, we have a MIND Institute scholars program. A major
impediment--and we have heard this today--to rapid progress to
research on autism is the relatively small number of scientists
and clinicians who have autism as their primary area of
interest. To encourage young scientists to enter the field, the
MIND Institute has funded pre-doctoral students and post-
doctoral fellows throughout the University of California
system. It is hoped that these MIND Institute scholars will be
the future leaders of autism research.
Let me briefly highlight some areas of current and future
MIND Institute research. The first I would like to mention is
the biomarkers program.
One of the first grants funded by the MIND Institute was
awarded to a team from the California Birth Defects Monitoring
Program, who collaborated with Dr. Karen Nelson from the NIH
and with investigators from the MIND Institute. We heard a
little bit about this this morning.
The so-called blood spot study sampled the blood spots that
are taken from all children born in California. The
investigators sought to determine whether there might be
abnormal levels of certain peptides in the blood spots of
children who were later diagnosed with autism.
This highly risky--what some would call a fishing
expedition--made the striking discovery that several peptides
were elevated in children who later became autistic or mentally
retarded, but were not elevated in children with cerebral palsy
or normal control subjects. This has led to the suspicion that
more sophisticated techniques might provide a diagnostic marker
for those children who are susceptible to autism. Of course,
the significance of this finding is that there is substantial
suspicion that while autism has a genetic component which makes
children susceptible to the disorder, they must encounter
another factor--a so-called second hit--that brings on the
autistic symptomatology.
While it is not clear what the second hit may be--we have
heard that many parents and others are concerned that it might
be childhood vaccination or environmental contaminants--
regardless of the precise identity of the second hit, if
susceptible children could be detected at birth or before, once
the causative agents are determined, these children could be
protected from exposure. Therefore, finding a biomarker of
autism is the highest priority of the MIND Institute research
program.
One strategy is to employ the power of the Human Genome
Project. In January 2001, the MIND Institute announced that it
was allocating $1 million to develop a new neurodevelopmental
genomics laboratory. The laboratory aims to identify a genetic
profile or fingerprint of those children who may be vulnerable
to autism. The goal of this program is to have an accurate
diagnostic test that will be used to evaluate all children at
birth, like the children are currently tested for
Phenylketonuria.
A second initiative has been our vaccine-autism link
research. As initially described by Mr. Rick Rollens in
testimony to this committee on August 3, 1999--and we have
heard much about this today--there is strong suspicion among
parents that one ideology of autism of a child is associated
with child vaccinations. While many organizations have been
hesitant to take on this issue, the MIND Institute considered
this to be a fundamental area for immediate action. If there is
an identifiable culprit in existing vaccines that cause autism,
then the removal of the agent or changes in vaccination policy
could reduce future cases of autism.
In August 2000, the MIND Institute issued a request for
proposal for research leading to precise scientific data on the
potential links between vaccines and autism. With a private
donation of $1.2 million and additional funds from the State of
California, the RFP was advertised nationally and throughout
the UC system and several grants have already been funded to
carry on this research.
Another area of research is on the epidemiology of autism.
The California State Legislature commissioned the UC Davis MIND
Institute to carry out an evaluation of the factors that have
led to the nearly 300 percent increase in the number of clients
with autism in the regional center system and allocated $1
million for this effort. The principal investigator of this
study is Dr. Robert Byrd in our Department of Pediatrics.
The overarching goal of this study is to determine whether
factors such as in-migration or diagnostic shift can account
for some of the increase in clients with autism. If you can
discount some of these factors, then it has to be something
else and we will look at those factors as well. The study team
has been assembled. The field work is planned for September
through December of this year. The analysis and reporting of
results are slated for June 2002.
Another important area of work is what we call the autism
tissue program. Much of the progress that has been made in the
understanding of Alzheimer's Disease has come from the
neuropathological and molecular biological analysis of post-
mortem brain tissue. Literally hundreds of thousands of brains
have been evaluated through recruitment at Alzheimer's research
centers throughout the United States. In contrast, fewer than
40 autistic brains have been subjected to post-mortem analysis.
While it is clearly a very difficult issue that requires
utmost sensitivity and compassion, progress in the
understanding of the biology of autism will rely on the
acquisition of well-preserved brain tissue from autistic
patients. So to facilitate the goal of acquiring and
distributing this resource, the MIND Institute has joined
forces with the autism tissue program, sponsored by the
National Alliance for Autism Research and Autism Society of
America Foundation, to carry out the nationwide campaign to
make parents and families aware of the need for tissue
donations and to develop an efficient acquisition network that
will allow optimal use of this precious resource.
And the last area I wanted to mention is a recently
announced international meeting for autism research. There is
currently no national or international meeting that brings
together all scientists carrying out research in autism. The
MIND Institute has joined with Cure Autism Now and the National
Alliance for Autism Research to launch the first international
meeting for autism research in San Diego on November 9 and 10
of this year. This meeting will encourage presentations of all
types of research dealing with any aspect of biological basis
of autism or experimental approaches to treatment.
It is expected that this meeting will contribute to
increasing the awareness of new research findings and should
foster new areas of research as well as new collaborative
efforts.
So to summarize, the MIND Institute has quickly established
a multi-component research program that is designed not only to
help the children of today but those of the future. First, we
are building a strong local infrastructure that will be
uniquely capable of carrying out translational research on
autism. Patients will not only be diagnosed in the clinic, but
will become subjects for research. Once new findings lead to
new treatments, the clinic will be the proving ground for these
approaches. And once a new treatment is proven, it will be
distributed to institutions worldwide for implementation.
Second, at the same time as research is carried out in
Sacramento, the MIND Institute will support innovative research
throughout California and eventually, with adequate
fundraising, throughout the world.
Third, in addition to our own efforts, we will partner with
other advocacy and research groups, including the NIH, to
foster efforts that must be carried out through a concerted
effort.
Through building a strong research team and collaborating
nationally and internationally, it is my hope that we will
ultimately understand and defeat autism. In the meantime, the
MIND Institute will do everything in our power to treat
children who are currently afflicted and strive to prevent new
cases in the future.
Thank you very much.
[The prepared statement of Dr. Amaral follows:]
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Mr. Burton. Thank you, Dr. Amaral.
Dr. Miller.
Dr. Miller. Thank you, Mr. Chairman.
Thank you for inviting me to this congressional hearing. I
do so in my capacity as an epidemiologist who has worked for 22
years in the Public Health Laboratory Service in the United
Kingdom on vaccine-related issues, with specific expertise in
studies relating to vaccine safety.
For clarification, I should say that the PHLS in a non-
governmental public body whose role is to provide a national
capability for the diagnosis, surveillance, and prevention of
communicable disease and the provision of independent advice
about the control of communicable disease to help professionals
and the Department of Health. The remit of the Immunization
Division--which is part of the PHLS--of which I am head, is the
national surveillance of immunization programs, including the
safety and efficacy of vaccines that are in routine use.
Together with statistical colleagues in the PHLS and other
academic institutions, over the years I have conducted a number
of epidemiological studies designed to investigate various
putative adverse events after different vaccines, including
MMR, DPT, and more recently oral polio virus vaccine. These are
referenced in my CV.
In some of these studies, evidence of a causal link between
a specific adverse event and a vaccine has been found, and
risks as rare as 1 in 10,000, 1 in 22,000, and even 1 in
143,000 doses have been detected. In other studies of possible
adverse events, the results have been entirely negative. This
is the case with the epidemiological studies I have conducted
related to the postulated link between MMR and autism. Similar
negative findings have been found in other work conducted
elsewhere on the potential epidemiological link between MMR and
autism.
These epidemiological studies have been designed to test
the hypotheses implicit in the case reports and population
trends in autism that Wakefield and others have interpreted as
evidence of a causal link with MMR vaccine. The published
evidence cited--some parents of autistic children say that the
onset of symptoms in their child first occurred shortly after
MMR, that prior to MMR their child was developing normally,
that the onset of behavioral regression associated with MMR is
typically accompanying by bowel symptoms, and that there has
been an epidemic increase in the prevalence of autism which
coincides with the introduction of MMR vaccine.
The studies I shall describe have been designed
specifically to test the hypotheses that are implicit in these
observations. I think it is disingenuous of Dr. Wakefield to
say that he has inferred no hypotheses. I think it is also
disingenuous of Dr. Spitzer to say that the study I was
involved with was essentially a hypothesis-generating study. It
was specifically testing a prior hypothesis that was derived
from Wakefield's paper in the Lancet where the evidence that is
put forward for an association between MMR and autism is the
onset of regressive features or other behavioral disturbance
shortly after MMR.
In brief, the summary of the findings of the various
epidemiological studies--which are described in detail in my
written submission to this committee with full references--are
as follows.
There is no evidence that the onset of autistic symptoms is
more likely shortly after MMR vaccine than at any other time.
Indeed, new evidence which is shortly to appear from my
colleagues and myself in a vaccine journal shows that there is
no evidence that MMR vaccine increases the likelihood of autism
at any time after vaccination.
Children with autism are no more likely to have received
MMR vaccine than normal children. The introduction of MMR as a
routine immunization for children in the second year of life
has not been associated with a step-up increase in the
incidence of autism.
When analyzed by birth cohort, there is no correlation
between MMR uptake and prevalence of autism. I recognize that
the Wakefield hypothesis has now moved on and has evolved--
possibly under pressure of these epidemiological findings--but
it is important to remember that the published work of
Wakefield and others in relation to the putative link has been
tested in the studies I have just described the findings of.
Most importantly, the final finding I will describe and
show you the data from the study which is not yet published,
there is no epidemiological evidence to suggest the emergence
of a new syndrome of autistic enterocolitis associated with the
use of MMR vaccine.
As I said, this latest finding, which I think is most
pertinent here in relation to the postulated existence of this
characteristic regressive autism with autistic enterocolitis--I
would like to present the results of this later study here.
If it is true that vaccine-attributable cases typically
present with developmental regression and bowel symptoms, then
the proportion of such cases should have increased since the
introduction of MMR. That is a logical conclusion and a logical
inference from the hypothesis that is implicit in the data Dr.
Wakefield has shown.
To test this hypothesis, my colleagues and I have updated
our 1998 study of prevalent autistic cases in the North Thames
Region of England by carrying out a further survey in 2000,
2\1/2\ years later. The prevalence data of the more recent
birth cohorts shows that the rise in the early 1980's and early
1990's has now levelled off with no significant increase in
prevalence in birth cohorts from 1993 onward.
The current prevalence rate is about 1 in 350 to 1 in 400
children. That is a high rate. And I would like to make it
clear at this point that I do not in any way believe that this
is a condition which should not attract substantial amounts of
funding. We need to find the etiology and we need to find
effective treatments.
However, the question of whether there has been an epidemic
increase or whether that prevalence was there all the time but
has only been recognized with appropriate diagnosis and
referral mechanism I think is open to question. Certainly, my
colleague, Professor Brent Taylor, who is a consultant
community pediatrician, is of the opinion that the rise we had
seen prior to 1993 was due to improve recognition and referral
of cases rather than a real rise. I think the fact that it has
flattened off since 1993 is consistent with that interpretation
of the data.
However, the main purpose of this updated study was to test
whether there has been an increase in the proportion of cases
with regressive features and bowel symptoms associated with
MMR.
[Slide presentation.]
Dr. Miller. This shows that amongst children--there were
500 children in this survey--of children with regression--we
concentrated specifically on children with regression and bowel
symptoms. You can see there the portion of children with
regression categorized by whether they had ever had MMR or
indeed any measles-containing vaccine, whether they had that
vaccine prior to parental concern--those are the cases that
could possibly be caused by the vaccine, they were normal until
they had thee vaccine--or whether they had the vaccine after
parental concern. You can see that there is no significant
difference in the percentage of cases with regression by MMR
status.
A similar analysis done of the percentage of cases with
bowel symptoms by MMR status again shows no significant
difference between those three categories of autistic
children--no MMR, MMR before onset, or MMR after onset.
Looked at another way, if we look at the percentage of
cases with regression by year of birth, going from 1979 up to
1998--and remember that we introduced MMR in the UK in 1998, so
in the middle there--you can see there has been no change in
the proportion of cases with regression by year of birth.
Similarly, there has been no change in the cases of bowel
symptoms by year of birth. Neither did we find that there was
any characteristic bowel features in association with the use
of MMR vaccine, constipation and diarrhea. These results are
currently being submitted for publication.
In conclusion, in my view, the available epidemiological
evidence, both from the United Kingdom and elsewhere, does not
support a link between MMR and autism of the nature and
frequency implicitly postulated by Wakefield and others and the
basis of their published work so far. I recognize that the
hypothesis has now evolved and moved on. Indeed, it provides
strong grounds for rejection of the hypothesis that MMR is
responsible for the reported rise in autism and that such cases
are characterized by behavioral regression accompanied by bowel
symptoms.
Clearly, no epidemiological study could prove that MMR
vaccine never causes autism, however rarely. In this regard,
epidemiologists are no different from any other scientist in
that proof of a negative is impossible.
As with all epidemiological studies of any putative adverse
event, the existence of a rare, idiosyncratic causal
association cannot be entirely excluded. However, the existence
of such a putative association between MMR vaccine and autism
is at present entirely speculative.
Thank you.
[The prepared statement of Dr. Miller follows:]
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Mr. Burton. Thank you, Dr. Miller.
Dr. Gershon.
Dr. Gershon. Thank you, Mr. Chairman.
I am Dr. Michael Gershon, professor of anatomy and cell
biology at Columbia University in New York.
Life is often unfair. The unfairness of the life dealt to
autistic children, however, is so unfair that it defies
comprehension. The mental elements of autism, which may
sentence an innocent child to a life in virtual solitary
confinement, are bad enough. To have to endure that sentence in
gastrointestinal misery outdoes the trials of Job. The
withdrawal from social contact that characterizes autism is so
striking, moreover, that the abnormal behavior of afflicted
children has historically tended to blind non-parental
observers to symptoms from their gut, which in comparison, seem
trivial.
Historically also, the possibility that there might be a
pathophysiological link between the gut and the brain has not
been considered, even by scientists who should have known
enough to do so. Help to alleviate the gastrointestinal
accompaniments of autism, therefore, has only recently been
sought and investigation of the involvement of the bowel in
autism begun.
Given that the involvement of the bowel in autism has not
previously been studied, there is little that one can say right
now about the causes of that involvement except that it is a
topic worth considering. Certainly, the incidence of
gastrointestinal problems in children with autism appears to be
high and if one really looks for these conditions even higher.
Professors Wakefield, Horvath, and their colleagues, therefore,
have done a real service for patients and the biomedical
community in publicizing the association of gastrointestinal
abnormalities in autism.
At the start of a new field of research, such as the role
of the gut in autism, one naturally formulates hypotheses that
one can test. Hypotheses are very much a part of the scientific
method. Unfortunately, it is relatively easy to construct an
argument in support of a favored hypothesis, but an argument
differs from evidence and should not be confused with it. An
argument can serve to motivate hypothesis testing, but evidence
is required for hypothesis confirmation.
The hypothesis that MMR vaccine is a cause of autism is
supported at the moment by a well-crafted argument. There is,
however, little or no hard evidence available to support that
hypothesis. Furthermore, based on my understanding of
gastrointestinal function and the nature of the blood brain
barrier, I believe that it is unlikely that the hypothesis, as
originally formulated by Wakefield and others, that MMR causes
autism is correct.
The hypothesis that MMR is causally related to autism,
which has been associated with Dr. Wakefield, postulates that
the attenuated measles virus component of the vaccine persists
in the bowel of those vaccine recipients destined to manifest
autism as a result of their vaccination. The persistent measles
virus is thought to elicit an immune response that is then
postulated to increase the permeability of the intestinal
epithelium, giving rise to a ``leak.''
This leak enables toxic materials--in particular, opioid
peptides--to be absorbed from the intestinal lumen. These
toxins then enter the bloodstream and are carried to the
developing brain. The so-called rogue peptides, which are
derived from the gut, cross the blood-brain barrier and damage
the developing brain, giving rise to autism.
The evidence that measles virus actually persists in the
bowel is controversial. The idea that measles virus persists
has been recently been supported by Drs. Wakefield and his
collaborator, Dr. O'Leary, with data derived from sensitive
molecular biological techniques, which suggest that the virus
is present in the bowel, but in very low copy numbers.
These data are still largely unpublished, and the findings
have not yet, to my knowledge, appeared in a peer-reviewed
journal. Other investigators have not been able to reproduce
the molecular observations. Furthermore, test samples
containing coded amount of measles RNA from cultured cells and
from transgenic mice--which express the human measles virus--
that were sent to Dr. O'Leary by Dr. Michael Oldstone were not
read with the effectiveness needed to support the claims of low
copy numbers of virus persisting in the gut of vaccinated
individuals with autism.
Oldstone has concluded that the record of performance would
not be acceptable for certifying a clinical laboratory. The
virological support for the hypothesis of measles virus
persistence, therefore, is not established and cannot be
considered so until it is independently confirmed.
The data supporting the next step--the leak of toxic opioid
peptides into the body from the lumen of the bowel--is scanty
at best. Urinary observations of such are unreliable.
The thought that inflammation damages the epithelial lining
of the bowel, causing its permeability to increase, is
plausible. On the other hand, there is no reason that a leak in
the gut should be a one-way leak. Nor is there any explanation
as to how a leak could be specific so as to let only some
molecules through and not others of the same size and shape
pass through.
No movement of peptides or proteins from the tissue fluid
to the intestine has been detected in autism or as a result of
MMR vaccination. Protein-losing enteropathy has not been
reported to be associated with autism, nor has it been reported
to be a sequela of MMR vaccination in any significant number of
people.
On the other hand, if the bowel were to be permeable in a
size manner so that the large molecules of the body do not get
out, then small molecules from the gut would go both ways
through the proposed hole. That would cause massive
malnutrition and malabsorption in the patients, which has not
been reported.
So the absence of a telltale protein-losing loss or a
failure of absorption in patients en masse with autism and in
recipients of MMR vaccine thus suggests that the postulated
leak of the gut admitting opioid peptides does not indeed
occur. To paraphrase Sir Arthur Conan Doyle in Sherlock Holmes,
the failure of these things to occur and the failure of
absorption is the dog that did not bark. The postulated leak of
the bowel is thus unlikely to occur or to be significant.
The idea that opioid peptides or other toxins enter the
body from the bowel and cause autism overlooks another filter
that is in place to remove them, and that filter is the liver.
Everything the gut absorbs goes first to the liver as a
consequence of the circulation. There is no evidence that MMR
damages the liver. The postulated opioid peptides, therefore,
would have to be absorbed in overwhelming amounts to overcome
the ability of the liver to remove them. The liver is
exceedingly good at removing opioids. There is no other
toxicity noted in organs and the fact that the liver is there
and is normal in patients with autism suggests that this
postulated barrier is not overcome.
Finally, once the presumptively toxic peptides--if they
ever could--overcome the barriers of the intestinal epithelium
and the liver, which does not seem likely, the blood-brain
barrier remains. That barrier is constituted by special vessels
in the brain and it ought to be impenetrable to opioid peptides
or other toxins. How these so-called toxins get across is
unknown. One molecule that is large that does get across is
leptin, which is a natural hormone, but it has its own
transporter. No such molecules are known. So for a gut-derived
peptide to be a cause of autism, one has to assume that a
miracle occurs to cause the blood-brain barrier to open, like
the Red Sea did for Moses and the Israelites during the exodus
from Egypt.
Finally, there is no reason to assume that MMR is the
only--or even the most likely--reason for an association
between gastrointestinal disease to be associated with autism.
The nervous system of the gut, the enteric nervous system,
resembles the brain both structurally and chemically, and is
known to share its fate in other conditions, including
Alzheimer's and Parkinson's diseases.
It seems reasonable, therefore, to postulate that the
incidence of gastrointestinal symptoms in children with autism
is high because autism is a disease with manifestations in the
gut as well as in the brain. Alternatively, a brain that
functions abnormally because of autism may cause the bowel to
function abnormally. Similarly, if there is a problem in the
bowel, it can disturb the brain.
Let me tell you, Mr. Chairman, as I prepared for this talk,
I became painfully aware of the kinds of problems that can
happen in the bowel as the brain is disturbed. [Laughter.]
In summary, therefore, I think that there are alternative
explanations for much of this and that the preponderance of
evidence and the nature of the function of the gut, liver, and
blood-brain barrier combine to indicate that it is unlikely
that the hypothesis associated with Dr. Wakefield that MMR
vaccine causes autism is correct. The idea that the measles
virus persists in the gut of vaccinated individuals is
supported only by data that is controversial and has not been
confirmed.
The proposal that the bowel leaks due to measles virus
persistence and absorbs opioid peptides or other toxins assumes
a one-way leak. Since leaks are intrinsically not one-way, but
holes in a barrier, body proteins or ions would be expected to
flow out and no such movement has been detected in MMR or
autism.
The hypothesis that toxins are absorbed does not take
filtration by the liver into account or explain why gut-derived
peptides are not removed.
Finally, it does not explain why peptides can get through
the blood-brain barrier to cause autism and there are
alternatives which are more plausible that can explain the
association of GI malfunction in autism that have nothing to do
with MMR.
In closing, I would just like to say that I sympathize
tremendously and empathize with patients with autism and their
parents. But it may be counterproductive for patients with
autism, their parents, and for the whole population to devote
energy and resources single-mindedly to the pursuit of a single
theory of autism, when that theory might be false. The effort
diverts scarce resources from avenues that might be needed and
productive and should be devoted to this terrible condition.
Thank you.
[The prepared statement of Dr. Gershon follows:]
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Mr. Burton. Let me just start off by saying that I know
just a couple of things. No. 1, there is an epidemic. There is
a huge quantum leap in the number of children that are
autistic. That is irrefutable. That is No. 1.
No. 2, I know that my grandson, Christian, was a normal
child starting to speak and doing everything that was normal
and 1 day he got the DPT shot, he got the MMR shot, he got the
Hepatitis B shot, the Polio shot, and the Marcus Influenza
shot, and 10 days later he had those bowel problems, had
chronic diarrhea, ran around hitting his head against the wall,
flapping his arms, and he could not talk anymore.
That may be just a coincidence, but it happened. I saw it
with my own eyes, so something happened. Whether it was the MMR
shot or the mercury that was in these other vaccines or a
combination of the two, I do not know. But I do know that
hundreds of thousands of children in this country and around
the world are suffering because of autism, and many of them are
suffering from autism shortly after having received one or more
of these vaccines.
Dr. Haley, you said that there was about a 10-fold
occurrence of autism in children who had the mercury vaccines
and the MMR. I am not sure exactly how you said it.
Dr. Haley. I was not making any mention of the rate of
autism.
Mr. Burton. What were you saying?
Dr. Haley. It is on the back page of the handout.
When you compare the toxicity against the bank of enzymes
or against enzymes in a brain tissue, if you add the vaccines
that do not contain thimerosal, they show the least amount of
toxicity, essentially, very little at all.
Mr. Burton. Right.
Dr. Haley. If you use the same vaccine, only with
thimerosal added as a preservative, they are tremendously much
more toxic.
Mr. Burton. You said about 10 times, did you not?
Dr. Haley. I am being very conservative; 1 microliter of
these vaccines will totally inhibit these enzymes. You can
sometimes add 10 microliters of the non-thimerosal-containing
vaccines and see just a few percent----
Mr. Burton. You also said that similar things occurred with
the MMR vaccine.
Dr. Haley. We also measured the mercury level because some
of the vaccines we received had been used a bit. We looked at
the level of mercury. It fit what you would expect. There are
low levels of mercury in the non-thimerosal-containing
vaccines. There is some in all of them. The ones that had
thimerosal added were quite high.
The MMR came across as if it had no thimerosal added. There
was a small amount in there. I think it would be similar to
those that had no thimerosal added. There was mercury in there,
but not very much.
Mr. Burton. There was mercury in the MMR vaccine?
Dr. Haley. Yes, but a very small amount.
Mr. Burton. But there was mercury in the vaccine?
Dr. Haley. Yes, but the toxicity----
Mr. Burton. Merck, when we called awhile ago, said that
there was no mercury in the MMR vaccine. You are saying that
there was a very small amount.
Dr. Haley. Yes, we found it. I would want to do 20 of them
before I came up with an average, but we did find a small
amount of mercury. It was very tiny, though.
The MMR vaccine, unlike those vaccines without thimerosal,
was very toxic. It was as toxic as if it had thimerosal in it.
Mr. Burton. So would you say it was 10 times more toxic
than a vaccine without thimerosal?
Dr. Haley. I would say so, yes.
Mr. Burton. Dr. Spitzer and Dr. Wakefield, I am sure you
are squirming there. Would you like to make any kind of comment
about what you just heard? [Laughter.]
Dr. Wakefield. Generally, Mr. Chairman, or in specific
relation? [Laughter.]
Mr. Burton. The whole hypothesis of your research was
pretty much trashed by the last two witnesses.
Dr. Wakefield. I think Dr. Miller confuses inference with
implication. She says that implicit in what we had written was
a hypothesis. That, unfortunately, was her inference rather
than our implication.
What we have written--and this is one of the earliest
articles where we articulated a hypothesis--I am afraid this is
in scientific jargon--the hypothesis hypothesized that autistic
enterocolitis is an emergent, inflammatory bowel disease that
follows a low-dose compound viral exposure. Basically, that
this subset of autism with an inflammatory disease is an
emergent form of inflammatory bowel disease that follows a very
atypical pattern of viral exposure that requires not one virus
but an interaction between viruses and possibly other things as
well.
And we go on in that same paper--and I will not go into the
details because it is too much scientific jargon--but it comes
back very much to what Dr. Bradstreet was talking about. If the
developing immune system is impaired in some way from
developing an appropriate anti-viral response to exposure to
mercury or other vaccines, if it is skewed in the wrong
direction, then it may behave aberrantly in the face of a
virus.
I am very happy to provide Dr. Miller with a copy of this
paper and I will include one for your records.
Mr. Burton. Thank you.
Dr. Spitzer.
Dr. Spitzer. I would first like to make a comment.
There has been implication about comparing benefits and
costs or good and harm in this situation. The understandable
zeal, as indicating in the Institute of Medicine report, of
coming close to wiping out a disease and the sequela of measles
through the measures that are being taken is a very laudable
goal.
If we think, on the other hand, that say 10 percent only of
autistic children are those in which we eventually find a link
between the disease and that vaccine were the case, a
conservative estimate is 150 children per 100,000 with autism--
reducing it by 10 percent is reducing 15 near deaths, if you
wish, in the community.
With respect to the other side of the coin, comparisons are
almost always made, as I have read them recently in the
literature, with no immunization at all as opposed to making
the reference the best acceptable alternative, which is
univalent measles vaccine. The grandchildren I have I want to
have vaccinated, but with univalent unless it is clarified.
That would reduce in UK statistics, which I only give in a
preliminary way--I was just looking at them last Friday for the
first time--going from second to MMR meant a reduction of about
16 per 100,000 to usually zero or close to zero in developed
countries like the UK. It really is about the same, even if
only 10 percent of autistic children are affected.
That means it is important that we look at subsets, even
small subsets. If we can prevent 10 percent of autism by a more
judicious strategy of immunization, to that extent we will have
balanced the ledger of harm.
Last, I would like to stress in my case, I call myself a
worried agnostic. I do not know whether there is an
association. I think the evidence leans slightly in the
direction of supporting an association. Perhaps causation, but
at least association. I only feel that I am involved in one
cause, and that is the pursuit of truth through scientific,
admissible science, even if it takes 4 or 5 years to get to the
first step.
Mr. Burton. Thank you, Dr. Spitzer.
Mr. Waxman, do you have some questions?
Mr. Waxman. Yes, I do.
Thank you, Mr. Chairman.
Dr. Wakefield, Marie McCormick is the Chair of the
Institute of Medicine's Committee on Immunization Safety
Review. She said at the press conference at the release of the
report that the MMR vaccine is as safe as a vaccine can get.
How do you respond?
Dr. Wakefield. That is a very interesting comment. It is
rhetorical inasmuch--let me put it this way. When the vaccine
was first put together in 1969, one of the concerns I had in
particular was that of interaction of viruses one with another.
It is called viral interference.
Mr. Waxman. Dr. Wakefield, we are limited to 5 minutes
each, so I would really like a very terse and clear response.
Dr. Wakefield. When the MMR was first put together, it was
evident that the viruses interacted one with another. That was
assumed to be a benign process. That was a major mistake, in my
impression. I do not believe that when you put them together it
is a benign process. It alters the outcome from the vaccine, it
alters the immune response.
Mr. Waxman. Do you think the MMR vaccine is as safe as a
vaccine can get?
Dr. Wakefield. No, absolutely not.
Mr. Waxman. That is your view, but the Institute of
Medicine is not the only organization that disagrees with you.
Your work has also been scrutinized by the Medical Research
Council and the American Academy of Pediatrics and none of them
has found any evidence to support your hypothesis.
Dr. Miller, in your testimony, you demonstrate that the
proportion of autistic children with regression or bowel
symptoms has not changed over the period in which the MMR has
been used in the UK and is also no different for children who
have never had an MMR vaccination or those who developed autism
after the vaccine.
What does that suggest about Dr. Wakefield's theory?
Dr. Miller. I obviously do not want to put hypotheses into
Dr. Wakefield's mouth. The hypothesis I would infer that should
be tested on the basis of his suggestion of an autistic
enterocolitis syndrome is that there should have been an
increase in the proportion of such cases with regression and
bowel symptoms associated with the use of MMR vaccine. I cannot
find that in a large sample. I find that at variance with any
inferences I might make about what I would expect to have
happened on the basis of Dr. Wakefield's theories.
I therefore have to come to what I believe is a reasonable
conclusion that my observation does not support his hypothesis.
Mr. Waxman. In other words, your new findings show that MMR
is not linked to bowel syndrome and is not linked to autism.
And this research, combined with the IOM report, really show
that there is no evidence to support a causal connection
between autism and MMR.
We have limited resources to devote to this cause. As a
public health official and an epidemiologist, do you think that
more resources should be devoted to investigating the MMR-
autism connection? Or are there better places to devote our
resources?
Dr. Miller. As I said in my testimony, I think the question
of what is the cause of autism--it is a common condition and we
need effective treatments--is extremely important to answer. I
think that there have already been quite a number of resources
devoted to the question of MMR and autism, both looking at the
evidence by expert committees plus individuals like myself
doing as best we can with epidemiological studies. These have
been uniformly negative.
As I said in my oral testimony, one cannot rule out a rare
idiosyncratic response. However, in relation to what is the
major cause of autism, I am firmly of the view that MMR has
been excluded as a major cause of autism. Therefore, I do not
think it would be profitable to--if you like--hijack the
research agenda to concentrate on answering this question,
which is derived basically from speculation and unsubstantiated
and, as yet, still unpublished evidence in relation to MMR and
autism.
Mr. Waxman. Thank you.
Dr. Gershon, an important part of Dr. Wakefield's theory,
as I understand it, is that the measles virus persists in the
gut. Yet from what I understand, no other scientist has been
able to replicate Dr. Wakefield's findings of the persistence
of measles virus in the gut. Moreover, I also understand that
Dr. O'Leary, Wakefield's associate who does the looking for the
measles virus, was tested to see if he could correctly identify
measles virus in infected samples and he failed that test.
Do you know if that is correct? If so, can you explain the
significance of this?
Dr. Gershon. It is correct. And the significance of it is
that the evidence we have heard--which is largely unpublished
and is not supported or duplicated by other laboratories--is
not adequate to support Dr. Wakefield's hypothesis. So the
evidence that the persistence of measles virus goes on in the
gut is simply unfounded at the moment.
Mr. Waxman. Mr. Chairman, I would like to ask unanimous
consent if I could have another 5 minutes to pursue questions
because I have a conflict and have to run to another meeting.
Mr. Burton. Go ahead.
Mr. Waxman. Dr. Haley, your research demonstrates
thimerosal inhibits enzyme activity and that demonstrates that
the thimerosal, in your experience, is dangerous to the enzyme
in the petri dish.
Don't we need to know how much thimerosal is in the vaccine
before we know whether it is dangerous to a human being?
Dr. Haley. Toxicity is always related to dose, but also
size, the ability to clear it, the health of the patient, the
metabolic status, if they were suffering from a spurious
ailment it would be more toxic.
Mr. Waxman. So the research you are presenting today does
not definitively answer the question of whether the amount of
thimerosal in childhood immunizations is dangerous or not, does
it?
Dr. Haley. That it is dangerous?
Mr. Waxman. Yes.
Dr. Haley. I think if you consider the aspect that we are
dealing with multiple toxicities and exposures to mercury from
a lot of different sources that adding an abundance of mercury
to a child----
Mr. Waxman. My question, though, is whether the amount of
thimerosal in the childhood immunizations is dangerous, the
amount that is in there. There may be other exposures.
Dr. Haley. The amount from the vaccine alone would probably
be not enough by the data we have seen. But again, that would
depend upon the health of the patient you are giving it to.
Mr. Burton. Would the gentleman yield?
Mr. Waxman. Sure.
Mr. Burton. Is there a cumulative effect of mercury----
Dr. Haley. Yes.
Mr. Burton. In other words, my grandson--and I appreciate
you yielding--got nine shots. I think four or five of those
shots he got on that 1 day contained mercury. They said that
was 41 times what was normal.
Would that cumulative effect have an adverse impact?
Dr. Haley. Absolutely.
Mr. Burton. Did you hear that, Henry?
Mr. Waxman. What was that answer? [Laughter.]
Dr. Haley. There are a lot of reports out there with
infants that have been exposed to excess ethyl mercury
generating compounds.
Mr. Waxman. Are you aware of an abstract study funded by
NIH that looked at the blood mercury levels of full-term
infants following the administration of thimerosal-containing
vaccines?
Dr. Haley. Yes, I am. My opinion on that is that blood
mercury levels have been considered by many people not to be
worth very much to the extent of mercury toxicity. It is a
retention toxicity.
Mr. Waxman. I would like to read the conclusion of that
abstract. ``Low levels of mercury can be detected in the blood
of some full-term infants following the administration of
vaccines containing thimerosal. None of the blood mercury
levels observed in the studied infants exceeded the most
recently revised lowest level of maternal blood mercury
considered to represent a potentially significant exposure to
the developing fetus.''
That seems to disagree with your testimony. That seems to
be at odds with what you are saying.
Dr. Haley. If anybody is saying they can look at the level
of mercury in blood after a vaccination and then come to the
assumption that this did no harm to that patient, I sincerely
disagree with them.
Mr. Waxman. Does the research you have represented today
prove that the mercury in vaccines causes autism?
Dr. Haley. Absolutely not.
Mr. Waxman. In your testimony, you stated that infants
cannot clear mercury from their bodies. But a recent study
conducted by the University of Rochester testing mercury in
infants found that mercury was detected in the infants' feces.
Don't these findings prove that infants can clear mercury
from their bodies?
Dr. Haley. I did not say they could not, I said that they
could not do it as well. They have reduced bilary transport. It
takes a while for that to develop. And from what I understand,
they get the vaccination on the day they are born.
Mr. Waxman. Dr. McDougle, first I want to begin by
commending you for the excellent work you are doing to advance
our understanding of how to treat autism. Much of your
attention is focused on determining the causes of autism, and
that is important, but it is also important to help individuals
and families who are suffering now.
I understand you are in the middle of a 5-year grant to
develop medications to treat the symptoms of autism. Can you
give us a preliminary assessment of the effectiveness of some
of the medications you are studying?
Dr. McDougle. Yes. I would say that the first study we
completed was with a medication called Risparidone. Although
the blind has not been broken yet and we are not aware of who
was on which placebo or drug, certainly a number of children
have improved and benefited with particular improvements in the
areas of aggression, self-injury, irritability, and I think has
ultimately improved their quality of life.
Mr. Waxman. So some of them are working?
Dr. McDougle. Yes.
Mr. Waxman. Thank you very much, Mr. Chairman and my
colleagues.
Mr. Burton. I hope you did not miss the response from Dr.
Haley on that one thing because we have asked this question of
others when you were not in attendance, and that is that the
mercury in the vaccines has a cumulative effect. If the child
gets eight or nine shots in 1 day, as my grandson did, he is
getting an exorbitant amount of mercury in one dose. In my
grandson's case, 10 days later he was autistic.
Dr. Weldon.
Mr. Weldon. I want to thank all the witnesses. For me,
personally, I am just trying to find out how we can direct our
research funding better to try to get some answers to some of
these questions.
Dr. Miller, you described the Public Health Lab as being a
non-governmental public body. Do you get funding from the
British Government, though?
Dr. Miller. Yes, in the same way the National Health
Service is funded by the British Government, but we are not an
arm of government. Our relationship to the Department of Health
and Government is the same as the UK National Health Service.
Mr. Weldon. Is all your funding from the government? Or
does some of it come from other entities? Specifically, does
any of it come from the pharmaceutical industry?
Dr. Miller. Our core funding comes from the government. As
with the National Health Service, researchers like myself apply
for funding from research agencies, research funds from the
Department of Health. I have no commercial interests in any
vaccine company. I do not act as a consultant or an advisor to
a vaccine company. I do, along with other individuals, have
research funds for specific studies, largely clinical trials,
from vaccine companies. I have not been sponsored from any of
the work that I do on autism from vaccine companies.
I should say that in relation to the circumstances under
which any funding comes from such commercial sources, the legal
department of the Public Health Laboratory Service draws up a
very stringent contract with the commercial company to ensure
that there is total scientific independence of the PHLS in
publication and interpretation of those results. This is a
standard procedure for organizations such as the PHLS.
Mr. Weldon. So you are saying that the funding comes from
the British Government and some of it does come from
pharmaceutical companies, but you have these----
Dr. Miller. A small amount for specific research projects.
I am also an advisor to the Medicine Control Agency, that
is similar to the FDA. And as a requirement for that, we have a
declaration of interest. Should members of the committee wish
to see the funding I have received and for what purposes, then
they are free to view that. I am not sure if it is on the MCA
Web site.
So there is a full declaration of interest. The ability to
provide independent scientific advice is scrutinized by the MCA
in relation to the type of financial benefit that is received
for research studies from companies. I have not been prevented
from having any input over advisory matters in relation to the
research funding that I have received.
I should say, it is a very small proportion of the total
amount I have received for research studies.
Mr. Weldon. It would be very comforting to me if the PHLS
would just spend $500,000 and try to recruit 50 kids with
autistic spectrum disorder and gastrointestinal symptoms and
just scope them and try to duplicate his findings. It is very
little comfort to me, all these epidemiologic studies, because
the hypothesis is not that MMR causes all forms of autism. If
you are operating under the assumption that MMR causes a small
percentage of the cases of autism, then that may be very, very
difficult to detect in an epidemiologic study.
If the British Government is all concerned about
vaccination rates declining because of Wakefield's findings,
why don't they just scope 50 kids? What is the problem?
Dr. Miller. I would like to say first of all that you have
put your finger on the nub of the question here. I think you
have accepted that the epidemiological evidence has already
excluded MMR as a common cause of autism. I said in my
testimony that it is impossible epidemiologically to prove that
it could never cause it.
So the question is, for how rare an event would you like a
study to be set up to exclude or to find that sort of risk?
For the purposes of spending public money, if one has
excluded MMR as a frequent cause of autism----
Mr. Weldon. I would like to interrupt you, because I have a
limited amount of time.
He came in my office and showed me the pictures. I have
spoken to people. I am an internist. These kids have florid
inflammatory bowel disease. Why can't somebody duplicate this
study?
We have this poor, lone guy coming here constantly, year in
and year out. [Laughter.]
And Dr. O'Leary, might I say, is the guy who identified
Herpes Simplex Type A. He came here to the NIH and all of the
people at NIH supposedly dismissed it as being invalid and
ultimately it was found to be true that Herpes Simplex Type A
causes carposisarcoma. O'Leary is a very, very reputable
scientist.
Why can't we repeat O'Leary's data?
Dr. Miller. First of all, we have to wait to see the
virological findings published in a peer-review journal. As Dr.
Gershon said, we have not yet seen those.
The Public Health Laboratory Service, as I mentioned, its
remit is the national diagnosis, surveillance, and prevention
of communicable disease. Autistic enterocolitis, as far as I am
aware, is not demonstrated to be a communicable disease, nor
indeed to result from vaccination.
Now whether there is a syndrome called autistic
enterocolitis which has distinctive pathological features,
fenotific presentation is another question. And maybe
gastroenterologists, in combination with autism experts should
be looking at that. It is not a question for PHLS.
Mr. Weldon. The responsibility to duplicate his work is not
something that your department would----
Dr. Miller. Our responsibility would relate to the
question, if there is such a syndrome, Is there evidence that
it is associated with MMR?
Analyses of that has come to the conclusion that no--
whether or not there is such a syndrome, whether or not it has
relevance to the current prevalence of autism is another
question, and academic institutions with expert
gastroenterologists and autism experts may indeed be looking at
this.
I would say the Medical Research Council has funded a large
study to look at the question of etiology of autism and what
the risk facts are to try to throw some light on it, but it is
not a question related to vaccines or communicable disease.
Mr. Weldon. I have some questions for Dr. Gershon.
This is not published, but I have been told by some of the
people doing research in treating children with autism that a
substantial percentage of them do have elevation in their liver
function tests.
If that were published and proved to be true, would that
affect your opinion regarding this theory of these neuroactive
peptides?
Dr. Gershon. It would affect my opinion if the elevation of
liver function tests were such that it would affect the ability
of the liver to act as a filter.
Mr. Weldon. So you would want to see very significant
elevations, not very mild elevations.
Dr. Gershon. For example, jaundice.
Mr. Weldon. You would want to see jaundice?
Dr. Gershon. I would like to see some evidence that the
liver is failing in its job as a filter. I would also like to
have some evidence that material is moving from into the gut
from the body. I would like to see some evidence that the
intestinal epithelial barrier is failing. And I would like to
see some mechanism to get whatever toxins are so-called
absorbed through the blood-brain barrier.
Mr. Weldon. Regarding the blood-brain barrier, it was
brought to my attention that a Dr. Connolly published in the
Journal of Pediatrics in May 1999. Maybe you might be familiar
with this study. The title of the article was ``Serum
Autoantibodies to Brain in Landau-Klefner Variant, Autism, and
Other Neurologic Disorders.'' It was basically showing
antibodies to brain endothelium.
Are you familiar with that study at all?
Dr. Gershon. I have seen the study.
Mr. Weldon. That does not affect your opinion at all about
this theory? That study has no impact?
To me, that study suggests that there could be a possible
link and explanation here. I am not saying there is, as a
scientist myself. I think I would want to see more research.
But you dismiss the theory outright, and that study suggested
to me that in some of these kids there may actually be a
breakdown in the blood-brain barrier.
Dr. Gershon. That study did not demonstrate a breakdown in
the blood-brain barrier. It showed autoantibodies. That is a
different issue.
The existence of antibodies--it could be an autoimmune
mechanism, I guess, is what you are implying--that helps to
break the blood-brain barrier down. There could be a lot of
things.
Every step along the way, an improbable event could happen.
But there are a lot of steps along the way.
I would like to direct your attention to two other points.
One part of my testimony and one further one.
I pointed out that there are alternative mechanisms by
which to explain the association between bowel disease and
autism. One need not postulate a set of improbable mechanisms
to get toxins into the brain. The bowel and the brain
communicate by other means. The fact that both are involved in
autism is, to me, established. As I said at the outset,
Professor Wakefield is to be commended for publicizing that.
On the other hand, I do not think it is established that
the reason for the link is MMR. The bowel has many mechanisms
of affecting the brain and the brain the bowel. The same
disease, autism, can give rise to symptoms in both places.
The other thing, in regard to what you said about scoping--
if the British Government or our Government were to scope a lot
of children and find inflammation in the bowel, I would expect
that they would in fact find that. Nobody, to my knowledge, is
quarrelling with the aspect of what Dr. Wakefield has
published, which is that some children with autism have in fact
inflammatory bowel disease. That is not in contention. What is
in contention is that resulted from MMR and that there is
persistent measles virus in it, that what they detect is not
just passenger leftover from the vaccine that is not real
virus.
It is very hard to show that. And Professor O'Leary--I am
not saying he is not a good molecular biologist. I think he is
an excellent molecular biologist. But when asked with coded
samples that were sent to him by Michael Oldstone to show that
he could detect these low copy numbers which are postulated, he
did not pass the test. He identified successive samples
differently on different occasions. He missed some diagnoses.
When there were very large amounts of measles virus, he could
detect it, as could everybody else.
And here we have a situation where other laboratories are
trying to duplicate this finding of measles virus, and they are
not doing it. Yet this laboratory has failed the test of coded
samples to do it.
Mr. Weldon. Mr. Chairman, could we have Dr. Wakefield?
Mr. Burton. Dr. Wakefield.
Dr. Wakefield. I am sorry, I have to take issue with that.
That is a complete misrepresentation of the data.
First, Dr. Gershon suggests that other people have looked
in the intestine of these children for the detection of measles
virus. No one has done that, to my knowledge. So the only
laboratory that has looked in the intestinal biopsies of these
children is Dr. O'Leary's laboratory. Other people have looked
in the intestines of children with Crohn's Disease for evidence
of measles virus, which we have suggested. Indeed, one of the
people on the panel of the IOM presented data at the American
Academy of Pediatrics last June showing that they had could
identify measles virus genetic material in children with
Crohn's Disease and some controls.
I want that to go on record. That has been presented.
So independently groups from Canada and from Japan have
found measles virus in the intestines of children with
inflammatory bowel disease.
The issue of the study with Michael Oldstone was not as it
was portrayed. I am very, very concerned that Michael Oldstone
should breach confidence of data that has not been presented in
any forum, and has not even actually been finally analyzed. But
in fact when they did analyze them, the only discrepancy was
that there was no contamination at all, but a very, very, very
low copy number of the virus, which the tacman PCR system--
which Dr. O'Leary helped develop--detects the virus found that
they might be able to detect it in two out of three samples.
This is merely a function of low copy viral detection. It
is now a function of the ability of us to find viruses in
vanishing small amounts with technology that is not available
in Dr. Oldstone's lab. So the data have not been presented
fairly, and I want that to go on record.
Mr. Burton. Dr. Weldon, you can keep the time, but I want
to make a comment or two because I have no more questions for
the panel. Then I will let you conclude the questioning.
A lot of kids are ruined for life. I detect a close-minded
attitude on something that is so important--not to one child,
my grandson, but to hundreds of thousands of kids. Every 3
hours in California--it was every 6 hours just about a year
ago--but every 3 hours in California, there is a new child with
autism. Every 3 hours.
It is a horrible, horrible thing to have to live with, not
just for the child but for the parents, the grandparents, and
everybody else, not to mention the cost.
So we have some people that have a closed mind about
various theories about this. I think this is a time for
everybody to be open to almost any theory, if it is cost-
effective, to look at it to see if it can be proved or
disproved.
I want to tell you a story. Louis Pasteur was kicked out of
the medical profession and ostracized for 17 years and then he
was knighted. And it was because everybody had a closed mind.
I have a very good friend who lives in Australia. His name
is Dr. Barry Marshall. I do not know if you have ever heard of
him or not. But I went to Africa and I was in the jungles of
Angola and I came down with a bug, I thought, because I could
not eat anything or keep it down for 2 years. It was awful. So
I went to gastroenterologists. I went to several of them. And
they all said it was my nerves and strain on my body. They gave
me Zantac and Prilosec and everything else under the sun.
Then I read this article about this guy named Barry
Marshall. I think it was in one of the major publications. He
was a scientist doctor from Australia. He said that the stomach
problems in 90 percent of the people in the world was caused by
a bacteria. Everybody said that a bacteria cannot live in the
stomach.
He went and gave a speech to a symposium in Belgium. After
he gave the speech--or right near the end--they literally
started laughing at him because it was impossible for a
bacteria to live in the lining of the stomach and he was crazy.
So he went home and drank the bacteria--not unlike what Louis
Pasteur did. He went home and drank it and got deathly ill and
cured himself with the combination that he gave me.
I went down to see him after 2 years of suffering and he
tested me. My doctor said I didn't have that. But I went to see
him and he gave me this concoction of bismuth and antibiotics
and something else. I took it for 2 weeks and I have not had a
problem since.
But the close-minded doctors who were experts, who had all
the answers, told me that I could not be cured, that I had to
take these stomach pills for the rest of my life. All I can
tell you is that we have a problem with kids that is humongous.
It is going to affect the whole world if we do not do something
because we are vaccinating kids all over the world. If mercury
or the MMR vaccine or whatever it is is causing it, we need to
find out and we need to find out pretty darn quickly.
For people to have closed minds when 1 out of 150 or 200
kids in Oregon or 1 out of 400 in the United States or 1 in 500
in the United Kingdom are coming down with autism is almost
criminal. You ought to explore everything to find out what the
answer is.
With that, I will shut up.
[Applause.]
Mr. Burton. Dr. Weldon.
Mr. Weldon. I just have a couple of quick followup
questions.
Dr. Wakefield, Dr. O'Leary came in my office and showed me
his PCR data, all the different versions of that. I think he
ran eight different types of tests. Why hasn't that been
published yet? We have had Dr. Gershon point that out
repeatedly that it has not been published. What is the problem?
Dr. Wakefield. There is no problem. It is being presented
for the first time at the American Gastroenterological
Association in Atlanta in May. It has been peer-reviewed and we
will see how that goes. But it is awaiting publication at the
moment.
We have been asked to provide strain-specific sequencing.
In other words, the acceptance is that the virus may well be
there. I sat down with Michael Oldstone himself who said that
he accepted that we found the virus. NIH's measles expert who
came to troubleshoot this said that the virus is there. But the
reviewers have asked for strain-specific sequencing. Those
studies are being conducted at the moment and we will put those
into the papers. It is an entirely reasonable question and one
that we are answering.
Mr. Weldon. So you expect publication after that issue is
decided?
Dr. Wakefield. Once we have addressed that issue, yes.
Mr. Weldon. Just one more question for you, Dr. Miller.
Were you on the original panel that approved the MMR in
England?
Dr. Miller. No, I had no role in that at all.
Mr. Weldon. That is all I have, Mr. Chairman. Thank you.
Mr. Burton. I want to thank you all very much. You have
been very patient. You have been sitting for a long time. You
have been very helpful.
We will submit all your statements and all your comments to
the health agencies here. We will continue to fight on to try
to find a solution to this problem, with your help.
Thank you.
We have one more witness who could not be with us tomorrow,
Dr. McCormick from the Institute of Medicine. She is the
chairman who did the report that we had heard about.
Dr. Weldon, you can stay for Dr. McCormick, I hope. She was
the chairman of the committee that did the report that was
recently released. I need you.
[Witnesses sworn.]
Mr. Burton. Do you have an opening statement, Dr.
McCormick?
Dr. McCormick. Yes, I do.
Mr. Burton. You are recognized.
STATEMENT OF MARIE MCCORMICK, MDSCD, CHAIR, COMMITTEE ON
IMMUNIZATION SAFETY REVIEW, INSTITUTE OF MEDICINE, ACCOMPANIED
BY WILLIAM COLGLAZIER, EXECUTIVE OFFICER, NATIONAL ACADEMY OF
SCIENCES; AND SUSANNE STOIBER, EXECUTIVE OFFICER
Dr. McCormick. Good afternoon, Mr. Chairman and members of
the committee.
My name is Marie McCormick. I am a professor and Chair of
the Department of Maternal and Child Health at Harvard School
of Public Health and I Chair the Institute of Medicine's
Committee on Immunization Safety Review, which released its
report on MMR Vaccine and Autism on Monday, April 23rd. I
appreciate the opportunity to provide testimony to you based on
the findings of this report. A copy of my testimony and the
executive summary has been submitted for the record.
Dr. William Colglazier, executive officer of the National
Academy of Sciences, and Ms. Susanne Stoiber, executive officer
of the Institute of Medicine accompany me.
As I mentioned, two committee members are here, Dr. Steve
Goodman and Dr. Constantine Gatsonis.
The genesis of this report was a December 1999 discussion
between the CDC and the IOM regarding the need for an
independent group to examine vaccine safety concerns. The CDC
and NIH formally engaged the services of the Institute of
Medicine in September 2000, which in turn appointed the
committee in November 2000.
The committee is comprised of 15 members with expertise in
pediatrics, immunology, neurology, infectious disease,
epidemiology, biostatistics, public health, genetics, ethics,
risk perception, and communication. To preclude any real or
perceived conflicts of interest, committee members were subject
to strict selection criteria that excluded anyone who had
participated in research on vaccine safety, received funding
from vaccine manufacturers or their parent companies, or served
on vaccine advisory committees.
The committee is charged with examining three vaccine
safety issues each year for 3 years. The committee was asked to
assess the scientific plausibility of the safety concern, the
significance of the issue in a broader social context, and to
suggest appropriate actions. The first hypothesis the committee
was asked to consider is the linkage between MMR vaccine and
autism.
The MMR vaccine has been extremely successful in virtually
eliminating measles, mumps, and rubella in the United States.
Measles cases, for example, dropped from over 400,000 per year
in the pre-vaccine era to only 100 in 1999.
Some are concerned, though, that the MMR vaccine might
cause autistic spectrum disorders. These are incurable,
permanent, and serious developmental problems in children and
adults. Scientists generally agree that most cases of autistic
spectrum disorders result from events that occur in the
prenatal period or shortly after birth. However, concern arises
about the MMR vaccine because autistic symptoms typically
become more evident in the child's second year, about the same
time the MMR vaccine is first administered.
A growing body of work has examined this subject. In a
study published in the Lancet in 1998, researchers describe 12
children who developed behavioral problems, including autism,
shortly after receiving the MMR vaccine. Since then, this group
and others have further examined this potential relationship.
To evaluate the hypothesis on MMR vaccine and autistic
spectrum disorders, the committee conducted an extensive review
of the published, peer-reviewed scientific and medical
literature. We held an open scientific meeting including a
broad group of researchers and vaccine safety advocates.
Finally, a working group of the committee conferred with
parents of autistic children and vaccine safety advocates to
discuss their concerns.
The committee concludes that the evidence favors rejection
of a causal relationship at the population level between MMR
vaccine and autistic spectrum disorders. The committee bases
this conclusion on the following evidence: a consistent body of
epidemiological evidence shows no association at a population
level between MMR vaccine and autistic spectrum disorders; the
original case series of children with autistic spectrum
disorders and bowel symptoms and other available case reports
are uninformative with respect to causality; biologic models
are fragmentary; and there is no relevant animal model.
However, the committee notes that its conclusion does not
exclude the possibility that MMR vaccine could in rare cases
contribute to autistic spectrum disorders resulting in a very
small number of affected children. This possibility arises
because the epidemiological evidence lacks the precision to
assess rare occurrences and the proposed biological models,
although far from established, are nevertheless not disproved.
In its significance assessment, the committee considered
the burden of measles, mumps, and rubella infections, the
burden of autistic spectrum disorders, and the level of public
concern. Measles, mumps, and rubella can lead to significant
morbidity and mortality and treatment of these diseases is
limited.
Outbreaks of measles, mumps, or rubella disease could
easily occur now were MMR immunization rates to decline as a
result of fears about MMR. Yet, because MMR vaccine is a
mandatory vaccine that is administered to healthy children--in
part, as a public health measure to protect others--the
responsibility of the Government to ensure the safety of the
vaccine is high. The burden of autism, an incurable and serious
disorder, requires consideration of all possible etiologies. In
addition, the level of public concern about MMR vaccine safety
is high.
Because of the limitations of the evidence, the significant
public concern surrounding the issue, the risk of disease
outbreaks if immunization rates fall, and the burden of autism,
the committee recommends that further attention be given to
this matter.
Specific recommendations regarding policy review, research
and surveillance, and communication follow.
In terms of policy review, the committee does not recommend
a policy review at this time of the licensure of the MMR
vaccine or of the current schedule and recommendations for
administration of MMR.
The committee concludes that further targeted research on
the possible contribution of MMR vaccine to autistic spectrum
disorders in some children is warranted. For example: use
accepted case definitions and assessment protocols for autistic
spectrum disorders to enhance the precision and comparability
of research results; explore whether exposure to MMR vaccine is
a risk factor for autistic spectrum disorders in some children;
explore whether measles vaccine-strain virus is present in the
intestines of some autistic children; and encourage all who
submit reports tot he Vaccine Adverse Event Reporting System
about MMR vaccine and autism to provide as much detail and
documentation as possible.
The committee heard from parents that obtaining unbiased
and accurate information on the possible relationship between
MMR vaccine and autistic spectrum disorder has been difficult.
The committee recommends that governmental and professional
organizations, CDC and the FDA in particular, review some of
the most prominent forms of communication regarding the
relationship between MMR vaccine and autism spectrum disorder.
Direct input from parents and other stakeholders would be
invaluable in conducting an evaluation of communication tools.
In its discussion of recommendations, the committee
identified more general concerns that it could not adequately
address in this report. It intends to address these in the
future.
This concludes my oral statement and I would be happy to
answer any questions.
[Note.--A copy of the Institute of Medicine publication
entitled, ``Immunization Safety Review,'' may be found in
committee files, or obtained by calling the National Academy
Press at 1-800-624-6242.]
[The prepared statement of Dr. McCormick follows:]
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Mr. Burton. Thank you, Dr. McCormick.
What does this mean? ``However, the committee notes that
its conclusion does not exclude the possibility that MMR
vaccine could contribute to ASD in a small number of children
because the epidemiological evidence lacks the precision to
assess rare occurrences of a response to MMR vaccine leading to
ASD and the proposed biological models linking MMR vaccine to
ASD, although far from established, are nevertheless not
disproved.''
What does that mean?
Dr. McCormick. What that means, I think is what Dr. Miller
said, that the level of analysis you are able to do could not
rule out rare occurrences.
In terms of the biological model, we were talking
specifically about the type of evidence Dr. Wakefield had
presented. Unfortunately, because it was an open meeting, Dr.
Wakefield was reluctant to present his full range of data
because it would also have to be put out on the Web and it was
considered pre-published.
Mr. Burton. I understand, and I do not want to cut you off,
I just want to bear on this question.
On television all across the country, we saw yesterday that
our health agencies and your committee said that the MMR
vaccine was not going to be a contributing factor and could not
cause autism.
Dr. McCormick. Based on the evidence that we got to the
committee, that is true.
Mr. Burton. What does this mean, that you just said?
Dr. McCormick. We are leaving the door open for additional
evidence because we could not hear the evidence that was being
presented. We were not provided the evidence on the presence of
measles vaccine. It does not mean that that whole theory is
going to be proven, we are just saying----
Mr. Burton. Let me read this to you again, ``although far
from established, are nevertheless not disproved.''
So what you are saying is that the causal link is not
disproved. Is that right?
Dr. McCormick. No, we are saying it is not established.
Mr. Burton. But you are saying that it is not disproved.
Dr. McCormick. It is not established, either.
Mr. Burton. So you do not know, do you? Can you say
categorically, 100 percent, that the MMR vaccine is not a
contributing factor to autism? Can you say that?
Dr. McCormick. No, because we said in rare cases.
Mr. Burton. That is the point. You put out a report to the
people of this country saying that it does not cause autism,
there is no causal link, and then you have an out in the back
of the thing. You cannot tell me, the committee chairman, under
oath, that there is no causal link because you just do not
know, do you?
Dr. McCormick. Because in part we were not provided the
evidence----
Mr. Burton. Do you know?
Dr. McCormick. I do not know.
Mr. Burton. Then why did you say so in the report?
Dr. McCormick. Because the bulk of the evidence----
Mr. Burton. Because the bulk of the evidence? But you do
not know. You just said that.
Dr. McCormick. In fact, most of the reports I saw indicated
that.
Mr. Burton. Do you know what it is like to have an autistic
child?
Dr. McCormick. I do.
Mr. Burton. You have an autistic child?
Dr. McCormick. No. My brother has two.
Mr. Burton. Your brother has two?
Dr. McCormick. Yes.
Mr. Burton. Then you know what he goes through?
Dr. McCormick. Yes.
Mr. Burton. Do you know how many kids are getting autism?
Every 3 hours in California, there is a new child with autism.
It used to be every 6 hours. You used to have 1 out of every
10,000 kids who were autistic.
We do not know all the answers. We do not know if the
mercury, the thimerosal in the vaccinations are causing autism.
You do not know for sure whether the MMR vaccine is causing
autism.
Dr. McCormick. I know it is not causing most of the cases
of autism.
Mr. Burton. But the point is, if you are the one that it
does cause--if your child is the one that does get it and we
find out there is a causal link, isn't that awful? Isn't that
awful?
I just have to tell you, as I said to the last panel--and
you heard what I said about Louis Pasteur and Dr. Barry
Marshall, didn't you?
Dr. McCormick. Yes.
Mr. Burton. This is such a serious thing with hundreds of
thousands of people that are going to be autistic and be a
burden on society for the rest of their lives, it is going to
cost us trillions of dollars--when you talk about 1 in 250 or
500 kids--they are going to grow up and they are going to be a
burden on society. We should not close the door to any avenue
of research to find out what is causing that.
It is not being caused just by genetics, I do not believe,
because you are having a huge quantum increase in it. Something
is causing it and we ought to be open to everything.
Dr. McCormick. In fact, the report, sir, does recommend
continued attention to this linkage.
Mr. Burton. I know, but that is not the point.
Of course, I read that. But most people in this country did
not. All they heard on television was that there is no causal
link, none. I heard doctors saying that this has been studied
by experts not connected to the pharmaceutical industry.
Now let me ask another question, because this is pretty
important, too.
You sent this report out to a group of people to look at,
didn't you?
Dr. McCormick. I did not send out the report.
Mr. Burton. Somebody sent it out, did they not?
Ms. Stoiber. I am sorry. I would answer those questions
because the committee is not responsible, the Institution is.
Mr. Burton. Stand up and be sworn.
[Witness sworn.]
Mr. Burton. Did you send out the report to be reviewed?
Ms. Stoiber. Not personally, but institutionally, we sent
out the report.
Mr. Burton. And you sent it to Linda Cowan, Eric Fombonne,
Neal Halsey, Samuel Katz, among others, right?
Ms. Stoiber. That is correct.
Mr. Burton. Neal Halsey and Samuel Katz are people that do
not subscribe to the theory that the MMR vaccine might be a
contributing factor, right?
Ms. Stoiber. I have no idea, sir, what they subscribe to.
Mr. Burton. Well, let me tell you they do. Those two people
do not believe that the MMR vaccine is a contributing factor to
autism.
You sent it to them for review, and I presume they went
through it and might have made some modifications--I do not
know--but you did not send it to Dr. Wakefield who is on the
other side of the issue. Why?
Ms. Stoiber. When we select a review panel--and there are
15 reviewers to this report--we try to select people from all
sides of an issue, those who believe there are connections and
those who believe there may not be connections. I think in fact
there are three reviewers that were specifically selected
because they have the confidence and have been engaged in the
research that would in fact be supported by the advocates of
this connection.
We take into account all of the reviews carefully. The
reviewer's comments are blinded. We do not know who they are
when we receive them. And no reviewer ever has the power to
change a word in our report.
Mr. Burton. Were any of these people presenters at the
conference?
Ms. Stoiber. Yes, two of the people were.
Mr. Burton. Who were they?
Ms. Stoiber. Dr. Fombonne and Dr. Miller.
Mr. Burton. Did Dr. Halsey or Katz, either one, present?
Ms. Stoiber. They did not.
Mr. Burton. They did not?
Ms. Stoiber. No.
Mr. Burton. Halsey and Katz have financial interests in
pharmaceutical companies. Fombonne and Miller did present?
Ms. Stoiber. That is correct.
Mr. Burton. And they did not agree with the thesis----
Ms. Stoiber. I am sorry. Dr. Miller did not present. It was
Dr. Volkmar, Ward, and Fombonne.
Mr. Burton. Dr. Fombonne was one of the people who reviewed
it and he was a presenter on the other side of the issue, as I
recall. He believed the MMR vaccine was not in any way
associated with the autism.
Ms. Stoiber. He reported the results of his study, which
showed no association.
Mr. Burton. And Dr. Wakefield was on the other side of the
issue. He was a presenter, as well, but he was not given a copy
of this to review.
Ms. Stoiber. The reviewers, sir, were not selected because
they were presenters, but were selected because they
represented a wide spectrum of views on the subject. The fact
that two of them also presented was totally coincidental and
they were selected for their ability to provide a broad
assessment of the evidence.
Again, we tried to balance, always, the reviewers selected
so that those who have opposing views are equally and well
represented among the reviewers.
Mr. Burton. Do you know if any of the people that reviewed
it--other than the ones I mentioned--had financial interests or
connections with any pharmaceutical companies that produced the
MMR vaccine?
Ms. Stoiber. To the best of our knowledge, they do not. In
fact, we do not do the same kind of extensive review of the
financial holdings of reviewers that we do of committee
members. But to the best of our knowledge, aside from the fact
that they may own mutual funds that hold pharmaceutical stocks,
there is no reason to believe there are any financial ties.
Mr. Burton. In the past, we have subpoenaed from the health
agencies--and we are still going through them--the financial
disclosure forms of people in the decisionmaking process who
make decisions on these vaccines. So therefore I would like to
know--and we would like for the Institute of Medicine to
contact the people on the review committee and ask them to
submit to us any holdings they have in pharmaceutical
companies. If I have to, I will subpoena that.
Would you tell them? And any that are connected with an
institution that gets grants from the pharmaceutical companies.
Ms. Stoiber. I will first say, sir, that they are not in a
decisionmaking process.
Mr. Burton. I understand. They were in the review process.
Ms. Stoiber. They solely reviewed. And after their reviews
were received, the committee had the ability to assess whether
or not to accept any of that advice. Some was accepted and some
was rejected.
Mr. Burton. When it was accepted, did it involve any
changes?
Ms. Stoiber. Very few.
Mr. Burton. Were any changes made after----
Ms. Stoiber. Always changes are made in response to review
because reviewers point out weaknesses in the analysis, they
point out lack of clarity in the expression, but I can say to
you that no central conclusions changed during the course of
review.
Mr. Burton. We will take a look at that and I will make the
decision on that after I review all this. But I want to know
about the reviewers and what recommendations they made and
changes. I would like to have that. I would also like to know
whether or not they had any interest or got any grants of any
kind from any pharmaceutical companies. I would also like to
have that information from any of the people on the original
report panel.
According to our request, we wanted to make sure that these
people are insulted who are working on this report from any
influence being exerted by any pharmaceutical company. I would
like to find out if any of the people who were on that panel
who wrote the report if they have any financial interest or
ties and whether they got any grants from any pharmaceutical
companies.
I wish you would take that request back to the agency and
tell them that, if necessary, we will be glad to send them a
subpoena to get this information.
Ms. Stoiber. I can assure you that no member of the
committee has any financial ties to the pharmaceutical
industry.
Mr. Burton. How about grants?
Ms. Stoiber. Or grants. I do not have the authority to tell
you that we can deliver the financial background of reviewers,
but I will certainly take that back the Academy and assess it
and get back to you.
Mr. Burton. You can tell them that I would like to have it
and if they choose not to send it, I will send them a subpoena
and I will get it.
Ms. Stoiber. I think we do not have the detailed financial
statements of the reviewers.
Mr. Burton. Then how can you tell me right now that they do
not have any financial interests?
Ms. Stoiber. Of the reviewers.
Mr. Burton. How about the people on the panel?
Ms. Stoiber. For those on the panel, we have extensive
financial disclosure.
Mr. Burton. Then I want it.
Ms. Stoiber. What we do not have is the same kind of
information for people who served as reviewers.
Mr. Burton. We want that and we want to know if they got
any grants of any kind from any of the pharmaceutical
companies.
Dr. Weldon, sorry to take so much time.
Mr. Weldon. Mr. Chairman, I ask unanimous consent to
introduce for the record a statement from the Middlebrook
Family of Indialantic, FL, in my congressional district, who
have struggled with autism.
Mr. Burton. Without objection, that prepared statement will
appear in the record.
[The prepared statement of Mr. and Mrs. Middlebrook
follows:]
[GRAPHIC] [TIFF OMITTED] T6856.134
Mr. Weldon. Dr. McCormick, you were quoted on CNN as saying
that the MMR vaccine is as safe as a vaccine can get. Is that
correct?
Dr. McCormick. Yes.
Mr. Weldon. If you were to find that the data, that the
epidemiologic studies that have been quoted today--which I
assume you reviewed and that played a key role in your
decisionmaking process--correct me if I am wrong.
Dr. McCormick. We were not aware of Dr. Miller's study at
the time of the decision.
Mr. Weldon. How about the Taylor study?
Dr. McCormick. Taylor, yes.
Mr. Weldon. If you were to find that any of that data was
defective, would that affect your opinion on the safety of the
MMR vaccine?
Dr. McCormick. First, I think in terms of the statement
that it is as safe as any vaccine can be, it is made with the
understanding that all vaccines carry some degree of risk and
side effects.
Mr. Weldon. Right.
Dr. McCormick. We carefully looked over that epidemiologic
data twice. Not only did we have a prepared review, but both
Dr. Goodman and Dr. Gatsonis looked at that information again
separately to look at the quality of that information.
I think any single study can be critiqued. It was the fact
that there were multiple studies with different kinds of
designs, looking at different populations, addressing different
parts of the pie, and all the results came out the same way. It
was the consistency of cross-studies that was impressive, not
that any single study could not have been critiqued as not
having addressed all issues.
Mr. Weldon. Were you looking at their studies or their raw
data?
Dr. McCormick. We were looking at the studies.
Mr. Weldon. Did you have access to the data?
Dr. McCormick. No.
Mr. Weldon. The committee has asked for the data and it has
not been made available to us.
Dr. McCormick. We did not have the data.
Mr. Weldon. Mr. Chairman, that is the only question I have.
Mr. Burton. Let me just ask one or two more questions.
I have here a list of the people that were on the
committee. The University of Washington School of Medicine,
Christopher Wilson--he is a professor there. Does the
University of Washington School of Medicine get any grants from
any pharmaceutical companies?
Or how about Alfred Berg, University of Washington? Or
Bennet Shaywitz, Yale University? Or Gerald Medoff, professor
of medicine and microbiology at Washington University School of
Medicine? Or Columbia? Or Michigan? Or George Washington?
All those schools get grants from pharmaceutical companies,
don't they? And don't those people who work for those
universities that get those grants know those grants are paying
for a lot of the research they are doing?
Ms. Stoiber. Our bias and conflict of interest excludes
only the personal situation of the individual serving on the
committee, their grant support or grant support in their
immediate labs. Clearly, it would be very difficult to compose
a committee of experts if you excluded every University in the
country because they receive some grant somewhere in the
university from the pharmaceutical industry.
Mr. Burton. I understand that. But the problem is, if you
are getting a large grant from a pharmaceutical company, and
you know that your laboratory at whatever facility you are
working at or employed by is getting that grant, and you know
that they have an interest in the decision being made, don't
you think that would wear a little bit on the processes on the
people on the commission?
Ms. Stoiber. I genuinely do not. I think these individuals
took this as the very highest level of responsibility to look
at the science on its face and were not influenced by external
factors of that nature. But clearly opinions could differ on
that.
Mr. Burton. Thank you.
Mr. Waxman.
Mr. Waxman. Dr. McCormick, a number of times during this
hearing Mr. Burton has impugned the integrity of the Institute
of Medicine's committee. As I understand it, the committee
established strict criteria for committee membership. No one
with any ties to vaccine manufacturers or their parent
companies was allowed to be on the committee. No one who had
ever served on a vaccine advisory committee was allowed to be
on the committee. Even people who had provided expert testimony
or had published about vaccine safety were excluded from the
committee.
Yet the chairman insists that the report is tainted by
bias. He says that after the committee wrote the report the
Institute sent it out to a panel of reviewers that contained
individuals with conflicts of interest and that those
individuals have biased this report.
My understanding is that reputable, published scientific
findings need to go through a review process. Is that correct?
Dr. McCormick. I would defer to Ms. Stoiber, who has been
answering these questions on institutional policy.
Ms. Stoiber. But I think he was asking about peer review
generally.
Mr. Waxman. If you have a reputable, published scientific
finding, doesn't that need to go through a review process?
Dr. McCormick. Absolutely.
Mr. Waxman. In fact, it would have been irresponsible not
to have the report reviewed. Isn't that correct?
Dr. Amaral. I think that is one of the safeguards of the
Institute of Medicine, that there is such an extensive review
of reports.
Mr. Waxman. Was this review process any different from the
process of publishing an article in a peer-reviewed journal?
Dr. McCormick. It is much more extensive. It is much more
critical.
Mr. Waxman. The chairman also continues to say that the
report changed after this review process. Is this true?
Dr. McCormick. There were changes of fact, there were some
changes of wording to more appropriate wording. There was no
change in the overarching conclusions of the report.
Mr. Waxman. Did the committee's recommendation change after
it received the reviewer's comments?
Dr. McCormick. No.
Mr. Waxman. If a parent came to you with concerns about the
safety of the MMR vaccine, after hearing all the evidence
presented to the panel and after hearing the deliberations of
the panel, what advice would you give to that parent about
whether to vaccinate their child?
Dr. McCormick. I would give the advice that the child
should be vaccinated. The risks of measles far outweigh the
risks for autism. We are talking about risks of death, risks of
severe chronic dementia called SSPE. These risks are real and
documented as a result of wild-type virus.
I think the risks of MMR and autism should continue to be
explored, but I do not think that MMR causes even the bulk of
autism. The committee did not feel they had enough information
themselves to make that kind of assessment, but that is my
personal view. The risks of wild-type measles are real.
Mr. Waxman. I said in my opening statement that the
committee concluded that there is ``no credible scientific
evidence establishing a link between the MMR vaccine and
autism.'' Is that a correct characterization of the committee's
conclusions?
Dr. McCormick. Yes.
Mr. Waxman. In Chairman Burton's opening statement, he
stated that ``the committee found that there was insufficient
evidence to prove conclusively or disprove a connection between
the MMR vaccine and acquired autism.''
That seems to me to be a gross mischaracterization of the
committee's findings. The committee could have chosen to say
that there was inadequate evidence, but you did not say that.
You said that the evidence favors a rejection of a causal
connection between the MMR vaccine and autism.
Why did the committee say that the evidence conflicts with
the theory that the MMR vaccine causes autism?
Dr. McCormick. The theory really has not been substantiated
with a full chain of evidence. As I mentioned earlier when you
were not present, Dr. Wakefield was unable to present his full
data because he was reluctant to present it in a public setting
before it was peer-reviewed. We left the door open that should
such data come in and look more solid and that there was a
causal chain we would clearly relook at the results. But it
seemed to be a long way away before that kind of causal linkage
was not only established but replicated in other laboratories.
Mr. Waxman. The Institute of Medicine report also states
``its conclusion does not exclude the possibility that MMR
vaccine could contribute to ASD in a small number of
children.''
Mr. Burton reads this and draws the conclusion that there
is a lot of uncertainty about the safety of the MMR vaccine. Do
you agree with this? Do you think the science raises serious
questions about the safety of MMR?
Dr. McCormick. No.
Mr. Waxman. When I read the report, I draw a different
conclusion than the chairman. We all know that it is very hard
to prove a negative. My understanding is that the Institute is
saying that it could not prove a negative. Is that correct?
Dr. McCormick. That is correct.
Mr. Waxman. This does not make MMR a likely cause of
autism. It does not even make the MMR theory an untested
hypothesis. Rather, the theory has been examined and all the
epidemiological evidence points toward rejection. Is that
correct?
Dr. McCormick. That is correct.
Mr. Waxman. My time is up. Thank you, Mr. Chairman.
Mr. Burton. But you cannot say categorically that the MMR
vaccine does not cause, in any causes, autism, can you?
Dr. McCormick. No, that is what the statement says.
Mr. Burton. Thank you.
Let me just ask you two more questions.
If it is true that autistic children do not get proper
medical evaluations to assess if they have gastrointestinal and
immune system disregulation, as pointed out by Dr. Wakefield,
how can the IOM committee conclude that the percentage of
children with autism caused by MMR is small?
Dr. McCormick. Because the bulk of the epidemiological
evidence shows no causal connection on a population basis.
In terms of the investigations Dr. Wakefield has
recommended, we, too, like Dr. Gershon, really applauded Dr.
Wakefield for expanding the notions of what the problems are
that these children have.
Mr. Burton. Dr. Weldon said to the people from England, why
don't you just take a look at 50 or 100 or 500 kids that have
autism and gastrointestinal problems and check to see if the
thesis is correct? Why not do that?
Dr. McCormick. We recommended continue attention to that
and for duplication of the results in the report. That was one
of the recommendations.
Mr. Burton. If that is one of the recommendations, that
research is necessary, why would you put out a report that
everybody in the country that was interested in this heard on
television saying that there was no causal link, period. That
is all we heard. I watched every channel and they all said the
same thing, that there is no causal link.
Yet you just said that you cannot make a categorical
statement like that.
That confuses a lot of people and it raises uncertainty
even to a higher level because people want to trust the
Government and this creates doubt.
I have one more question for you.
Since there has been a published report of vaccine-strain
measles causing encephalitis in a healthy child, why was it
stated in the IOM report that no such data existed?
Dr. McCormick. We did cite it. It was found that after the
primary hospitalization these children were found to have a
primary immune deficiency so that they were not previously
healthy children.
Mr. Burton. Would you give me that one more time?
Dr. McCormick. After hospitalization, the patient that had
this measles-strain encephalitis was found to have a primary
immune deficiency with a decreased CD-8 count and
hypogammaglobulin. So the inflammation was thought to be due to
immune deficiency.
Mr. Burton. So if a child has an immune deficiency, then
they are at risk for an adverse event?
Dr. McCormick. Children with immune deficiency are at risk
of a wide variety of adverse effects.
Mr. Burton. From the MMR vaccine?
Dr. McCormick. Not necessarily. It depends on the nature of
the immune deficiency.
Mr. Burton. Well, I want to thank you very much for being
here. I do want to say, though, that because this is such an
epidemic, I think our health agencies ought to look at every
possible avenue, and follow every possible avenue, to find out
if this is why we have this fantastic increase.
In Mr. Waxman's district in California, every 3 hours there
is a new case of autism. It used to be one in every 6 hours, as
you heard earlier. Nobody seems to have any idea why.
To rule out anything and then say at the end that in some
cases it may not be conclusive when you do not have all the
facts yet--you have not done a study on kid's guts that have
autism to see if that measles vaccine is in there. It seems to
me that is giving information that is not completely factual
and closing a door that probably should not yet be closed.
Also, on the mercury vaccine--which you do not have
anything to do with----
Dr. McCormick. Oh, yes, we do.
Mr. Burton. You will be working on the thimerosal issue?
Dr. McCormick. That is our next report.
Mr. Burton. Well, I hope you will be very, very thorough
and careful when you do that report because we will have you
back here again and ask you about that. It will be a very
thorough hearing once again.
And I have to tell you that in our own family--and I know
there are lot of people in this room who have autistic children
and grandchildren--a normal child, nine shots in 1 day
containing thimerosal and the MMR vaccine, and 10 days later he
is gone. I just have to tell you that is really bad and we have
an epidemic. We have to find the reason why.
Mr. Waxman. Mr. Chairman, my observation is this: autism is
an awful disease and we have to do everything we can to fight
this disease. But when we are trying to figure out how to fight
a battle, you only have a certain amount of resources. If we
take those resources and continue to go over and over and over
a line that seems to me not very promising, we have an endless
task of trying to reevaluate this theory, to try to prove
whether it is a negative or a positive. It seems to me that we
ought to make some decisions about whether we ought to be
asking the scientists where we should put the money to fight
autism.
Are we going to continue to reevaluate and have another
committee reevaluate Dr. Wakefield's theory? I do not want to
say that we should ignore it. I do not know the answer. I am
not a scientist. I cannot give an answer. But I do not know
that is the best place for money to fight autism.
And I would be interested in our committee trying to find
out from scientists--I do not think scientists who disagree
with Dr. Wakefield should be treated as if they are our enemy.
These are people from the Institute of Medicine. They have
devoted their lives to fighting disease. They are trying to
fight autism.
We ought to consult with them, not challenge them. We are
doing more than challenging them, we are trying to impugn their
integrity because they have not come to the same conclusion as
Dr. Wakefield.
We can keep putting money into Dr. Wakefield's theory over
and over and over again to where we could say, maybe it is true
and maybe it is not, instead of saying, maybe it is not but
maybe it is.
It seems to me at some point we ought to ask what the best
use of money is. Should we be looking for a vaccine for autism?
Should we be looking for medicines that can cure it? Should we
be doing something to help the parents? Should we be using the
money for research in trying to find out the causes? Or do we
know the causes?
It seems like we approach this issue as if we know the
cause and there is somebody trying to keep us from keeping it
open. I do not think we know the cause and I would like us not
to limit ourselves in our thinking and our approach to this
problem as if we know this cause and what we have is a grand
conspiracy to keep this cause from being public.
I think you have done a real service, Mr. Chairman, by
giving a focus on this disease and suggesting that we need to
understand that this a problem that is serious and seems to be
on the increase and we ought to fight it. But let us not get
diverted in our fight to an endless discussion of a theory that
I think is not a very promising one, from everything I have
heard in the hearings, we have had--and we have had many
hearings on this one theory.
So I hope we can work together to figure out some other
constructive ways to fight this disease because you and others
have expressed so strongly, emotionally, and well that it is
our obligation to do that.
Mr. Burton. Let me just end by saying that you have a great
deal of constraints on your time, Mr. Waxman, and we have had a
number of hearings. Generally, you come in and make a statement
and then you leave and do not hear all the testimony and you do
not have a chance to question all the witnesses.
I understand that you have these constraints on your time.
I just hope that in the future when we have these hearings that
you will be able to devote the time necessary to hear all the
witnesses instead of just coming in and making a statement and
leaving.
I do not want to cause acrimony between the two of us, but
that is one of the problems. And I know you have demands on
your time.
I want to say one other thing and then----
Mr. Waxman. I hope you will yield to me on that point.
Mr. Burton. I will yield to you.
Mr. Waxman. I do have a conflict in the time because I do
not get to set the agenda and we have other committees and
other demands. But I do have staff. And I do have an
opportunity to read the testimony. And I do have a chance to
evaluate what is said. I think in doing that I have a better
picture of what the different people are saying than if I sat
here and heard every single person but refused to believe those
that disagreed with my theory.
You can sit here for hour after hour and believe that those
who say that I am right are telling the truth and those that
say I am wrong are lying. That would be maybe a good use of
time, but not a good use of process by which hearings ought to
give us some conclusions.
Mr. Burton. As I understand it, the way that you come to
conclusions is you look at a whole body of people, and you see
if there is a causal link. As I understand it, you look for the
commonality of things like autism. It seems that the vast
majority of the people who are becoming autistic now--the one
common link is that they all suffered in relatively close
proximity to these vaccines, a huge percentage of them.
So there is a commonality there. So it is logical for many
people--myself included--to conclude that a lot of these
autistic kids are becoming autistic because of a combination of
thimerosal, the MMR vaccine--I do not know what--but that is
the commonality. That is the thing we see.
And we have heard that week after week, month after month,
with a whole host of people testifying from around the world.
Because of that, I think we need to take a very hard look and a
very thorough look at these vaccines and the contents of
vaccines and whether or not maybe separate vaccines should be
given.
Instead of the MMR vaccine, maybe it should be a measles
shot without preservatives in it. Maybe it should be a single
mumps shot. Maybe a single rubella shot. I know it would be a
lot more time-consuming and more costly.
We ought to find out if we need to have mercury or
thimerosal in vaccines. As I understand it, if you have single
shots, you do not really need that kind of preservative in
there and you can give a child a shot that does not have a
possible contaminant in it.
So I hope that in your review of these vaccines containing
things like thimerosal you will look very closely at that and
give us a report that will be very, very thorough.
Dr. McCormick, did you have a closing comment you would
like to make?
Dr. McCormick. I do not think anyone sitting around our
table is not concerned at our committee meetings about the
safety of vaccines. That is why we are there. But also millions
of children get these vaccines without developing the autistic
symptoms. What we are looking at in the epidemiologic
literature is the comparison of those with the vaccine and
without to see to what extent we can draw the association with
autism.
So that information does not support the linkage. But I do
not think there is anybody sitting around our committee table
that is not concerned about the safety of vaccines and is not
coming to it from a neutral point of view that if they saw a
risk they would not call it.
Mr. Burton. I understand and I appreciate your comment.
But I will tell you this: it used to be 1 in 10,000 and in
Indiana it is 1 in 400, and in Oregon it is 1 in 190 kids that
are autistic. There has to be a cause and it appears as though
one of the contributing factors are some of these vaccines.
With that, thank you very much for being here. We stand
adjourned.
[Whereupon, at 3:15 p.m., the committee was adjourned to
reconvene at the call of the Chair.]
[Additional information submitted for the hearing record
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AUTISM--WHY THE INCREASED RATES? A ONE-YEAR UPDATE
----------
THURSDAY, APRIL 26, 2001
House of Representatives,
Committee on Government Reform,
Washington, DC.
The committee met, pursuant to notice, at 10:10 a.m., in
room 2154, Rayburn House Office Building, Hon. Dan Burton
(chairman of the committee) presiding.
Present: Representatives Burton, Gilman, Morella, McHugh,
Weldon, Waxman, and Cummings.
Staff present: David A. Kass, deputy counsel and
parliamentarian; Mark Corallo, director of communications; S.
Elizabeth Clay, professional staff member; Robert A. Briggs,
chief clerk; Michael Canty, legislative assistant; John Sare,
deputy chief clerk; Corinne Zaccagnini, systems administrator;
Kate Anderson, Jon Bouker, and Sarah Despres, minority
counsels; Ellen Rayner, minority chief clerk; and Teresa
Coufal, minority staff assistant.
Mr. Burton. Good morning. A quorum being present, the
Committee on Government Reform will come to order.
The minority ranking member will be here shortly, as will
some of the other panelists. I ask unanimous consent that all
Members' and witnesses' opening and written statements be
included in the record. Without objection, so ordered.
I ask unanimous consent that all articles, exhibits and
extraneous or tabular material be included in the record. And
without objection, so ordered.
We're going to be hearing today from the National
Institutes of Health, the Centers for Disease Control and
Prevention and the Food and Drug Administration. Autism is a
neurobiological disorder. It locks a person inside himself or
herself. This disorder, which leaves children like my grandson,
Christian, unable to express themselves or interact with
others, is now at epidemic levels in this country, and I mean
epidemic.
One in 400 children in Indiana, 1 in 190 children in
Oregon, 1 in 150 children in Brink Township, NJ. How has the
Department of Health and Human Services responded to this
epidemic? Have our health agencies recognized this dramatic
rise and acted accordingly? If we generously estimate that NIH
has focused $60 million on autism, and that's generous, autism
research out of a $20 billion budget, that would mean that
their investment is 0.003, three thousandths of 1 percent.
Does that adequately address an epidemic that affects
between 1 in 190 children in Oregon and 1 in 500 children
nationwide? I'm including in the record a document taken from
the NIH Web site this morning that shows research initiatives
at the NIH and their funding for a 3-year period. We'll give
you all copies of this, we'd like for you to take that back
with you.
According to this document, NIH estimates they will spend
$45 million this year on autism. This is compared to $136
million on sleep disorders and $434 million on vaccine
development, which could be part of the problem, especially if
it's got mercury in it. Two of the issues that were discussed
at length yesterday were the concerns that the dramatic rise in
autism may be related to the MMR vaccine and mercury exposure
through childhood vaccines. We do not yet have enough research
evidence to make a conclusion one way or the other. Our health
agencies need to fund clinical and laboratory research that
will get the answers.
As we learned yesterday, epidemiological studies cannot
answer these questions. Epidemiology is important for looking
at incidence and prevalence, but not in answering questions
about causality. I have a short video showing the effects of
mercury on the brain. I think that's simply saying that we're
moving to get new vaccines on the market that have little or no
mercury. It's a step in the right direction, but I continue to
be concerned on behalf of the 8,000 children a day who may be
exposed to mercury through their childhood vaccines until the
current supply is used up.
And why that isn't being recalled by the health agencies of
this country, the FDA, I cannot fathom. As we speak, kids are
having mercury shot into their arms, and we know it's a toxic
substance. We had toxicology experts here yesterday talking
about it and what it does to the brain. We're going to show a
video on what it does to the brain.
And yet the people in the health agencies continue to allow
that to be done. And I cannot figure out why.
Yesterday we also heard about research that the NIH is
funding at the University of Rochester regarding mercury in
autistic children. We'll hear today how research is to evaluate
the level of mercury in the serum, the hair and the urine of
children receiving the currently recommended childhood
immunization schedule.
I hope that the reports will include the hair and urine
data as Dr. Haley, a leading mercury expert, suggested. Simply
reporting the blood data will be misleading. To only report the
blood data and not analyze and report the hair and urine
samples would be an injustice. We need to look at it all.
And I want to tell you something. We have 113 Members of
Congress that have signed up for the Autism Caucus. We're going
to end up with about 270, 280. And we're probably going to have
over half the U.S. Senate in the caucus. And if you think this
is going to go away, you guys are blowing smoke. Because I'm
telling you, I'm going to make sure that everybody in the
Congress knows the problems and knows what's facing us. If the
health agencies don't deal with this and deal with it quickly,
you're going to have a big problem over there.
I've also talked to Tommy Thompson, new head of the Health
Department. He's going to continue to talk to you, on a regular
basis, if we don't do something about this. It's unconscionable
that we have thousands and thousands of children being
inoculated and vaccinated with vaccines that have toxic
substances in them, and we see a horrible increase in the
number of people that are autistic and we continue down the
same path.
I just don't understand it. Last year the Centers for
Disease Control and Prevention reported that they did not know
why so many children in Brick Township, NJ, had autism. They
conducted a thorough evaluation of environmental toxins and
numerous other potential factors, but chose not to include
vaccine history as a part of their evaluation and report. Why
is this?
I believe vaccines are so important, but why they put three
and four and five and six and seven and eight and nine together
at one time, with mercury and other toxic chemicals in them
into our kids, I just don't understand. We have an epidemic on
our hands, and we cannot ignore any potential path that may
lead to ending the epidemic.
With that, we have this brief video that we'd like for you
to see that shows the effects of mercury on the brain and I
hope you'll pay particular attention to this.
[Video shown.]
Mr. Burton. That test was done in June 1999, almost 2 years
ago. I don't know if our health agencies are aware of it, but
in your comments today, I hope you'll address whether or not
you're familiar with that study, and whether or not our health
agencies have done like studies or taken an interest in that
and can respond to it.
[The prepared statement of Hon. Dan Burton follows:]
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Mr. Burton. Do you have an opening statement, Mr. Gilman?
Mr. Gilman. I want to commend the chairman and our
committee for looking into this problem, one that's long
overdue, and I thank you for the opportunity to be here.
Mr. Burton. Thank you, Mr. Gilman. I don't know if you're
familiar, but Congressman Chris Smith and Congressman Doyle
have formed what's known as the Autism Caucus. I don't know if
you're a member yet, but I hope you will join so we can make
sure every member is aware of the problems with it.
Let's start with Dr. Rennert. Do you have an opening
statement?
STATEMENTS OF OWEN M. RENNERT, M.D., SCIENTIFIC DIRECTOR,
NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT,
NATIONAL INSTITUTES OF HEALTH; KAREN MIDTHUN, M.D., DIRECTOR,
OFFICE OF VACCINE RESEARCH AND REVIEW, FOOD AND DRUG
ADMINISTRATION, ACCOMPANIED BY SUSAN ELLENBERG, M.D., DIRECTOR,
OFFICE OF VITAL STATISTICS AND EPIDEMIOLOGY; NORMAN BAYLOR,
M.D., ASSOCIATE DIRECTOR, REGULATORY POLICY, OFFICE OF
VACCINES; AND DR. COLLEEN BOYLE, ACTING ASSOCIATE DIRECTOR,
SCIENCE AND PUBLIC HEALTH, CENTER ON BIRTH DEFECTS AND
DEVELOPMENTAL DISABILITIES, CENTERS FOR DISEASE CONTROL AND
PREVENTION
Dr. Rennert. Mr. Chairman and members of the committee, I'm
Dr. Owen Rennert, Scientific Director of the National
Institutes of Child Health and Human Development at the NIH. I
appreciate the opportunity to provide information on behalf of
the NIH Autism Coordinating Committee about ongoing and planned
research activities at the NIH that are relevant to autism and
pervasive developmental disorders.
Autism, as you know better than I, is a cruel disorder, not
only as a result of the disability it causes, but also because
it is an illness that challenges the emotional bond between
child and parent. In its most severe forms, it effectively
isolates that child socially, cognitively, emotionally and
linguistically, denying other family members even the
opportunity to console and comfort.
In light of these immense human costs and the significant
public health burden that autism brings with it, the NIH is
working to focus the research community with ever-greater
intensity on this terrible disease. We appreciate the continued
involvement that parents have given us in that effort.
The Children's Health Act of 2000 called for expansion,
intensification and coordination of autism related scientific
programs at NIH. I'm pleased to report that significant
progress is being made, including toward the establishment of a
new network of centers of excellence in autism. The act
directed the Secretary of Health and Human Services to
establish an interagency autism coordinating committee, which
will include NIH, the Centers for Disease Control and
Prevention and other HHS agencies.
Yesterday, Secretary Thompson delegated to NIH authority
for establishing this coordinating committee. And we can assure
you, it will have at least three members from the parent
community of children with autism.
There has been considerable expansion and enhanced
coordination of autism research efforts at NIH. The amount of
NIH support autism related research grew from $22 million in
fiscal year 1997 to $52 million in fiscal year 2000. This
demonstrates the commitment of Institute members to the broad
intensification of autism research efforts.
As you requested, Mr. Chairman, we have supplied for the
record the 10-year funding history of NIH sponsored autism
related research, the list of projects funded in fiscal year
2000. We will also be supplying the abstracts of those funded
grants shortly.
Effective this week also, NIH has released an RFA, request
for applications, containing setaside funds for research
support for the development of autism centers applications.
This is part of an overall plan to support a variety of
investigative teams and wherever possible, to recruit the
participation of outstanding investigators who previously have
not worked in autism research. These grants would be funded in
September 2001 if meritorious applications are submitted.
A second RFA will be issued in fiscal year 2002 to solicit
applications for the centers of excellence with funding of the
first of these centers targeted for early in fiscal year 2003.
NIH anticipates a pool of approximately $8 million per year,
which will be available for the first 5 years of the funding of
those programs.
The Children's Health Act of 2000 calls upon NIMH, the
Institute of Mental Health, to take the lead in providing a
program under which samples of tissues and genetic materials
are donated, collected, preserved and made available for autism
research. NIH presently supports ongoing efforts by Harvard's
brain tissue resource center, UCLA and the University of
Miami's tissue banks, and recently special supplements were
awarded to target acquisition of necessarily biological
materials from individual with autism for focused study.
The network. In 1997 through an RFA, the National
Institutes of Child Health and Human Development with co-
funding from the National Institute of Deafness and
Communicative Disorders, established the networks on the neural
biology and genetics of autism, referred to as the
collaborative programs of excellence in autism.
Currently, we have enrolled nearly 2,300 patients with well
diagnosed autism in the network and are gathering data from
their families. A major ongoing CPEA initiative, a part of this
network that is co-funded by NICHD, NIDCD and the CDC is the
autism regression vaccine study. A principal goal of this study
is to assess temporal association between measles, mumps,
rubella vaccine and the onset of autism and attempts to
differentiate early and late onset forms of the disorder.
Another aim of this study is to try to replicate studies of
persistent measles infection in children with autism versus
those children who are not affected. Stage one of the project,
which got underway in September 2000, includes 1,600 well
diagnosed cases of autism and 1,250 healthy controls.
Individual vaccination records as well as records of the onset
of autism, specifically looking at the age of onset, the age of
recognition and the age of the diagnosis, will be examined in
this study.
Stage two of this project will attempt to replicate
previously reported findings regarding abnormal measles
antibody titers and persistent measles infection. In this
phase, investigators will examine 250 children with early onset
autism, 250 children with the regressive form of autism, 250
healthy controls matched to early onset cases, as well as 250
controls matched to regressive autism cases.
Neuroscience research, as you know, requires that we
understand the pathogenesis and cause of autism, and is the
most promising approach to ultimately developing targeted
effective treatments. Until the brain mechanisms responsible
for the manifestations of autism are understood, it will not be
possible to develop truly targeted interventions.
Treatment research also is currently focused on studying
the efficacy and safety of promising treatment interventions
which are commonly used in the community without adequate
testing or are aimed at specific impairing symptoms. These
include both psychosocial and pharmacologic interventions.
Last October, neuroscientists, including autism
researchers, parents, advocates and NIH program staff,
participated in a 1-day brainstorming session on the role of
the environment in autism which was organized by the National
Institutes of Environmental Health Sciences. This group
identified key priorities, large scale epidemiologic studies to
determine autism incidence and prevalence trends, studies to
describe the natural history of autism and to identify
meaningful subgroups that may be at increased risk from
environmental exposures in studies specifically to examine the
proposed association between regressive autism and thimerosal
in vaccines.
Mr. Burton. I don't know how much longer your opening
statement is, but we'd like to get to the questions as quickly
as possible.
Dr. Rennert. I'll abbreviate it.
I simply would indicate to you that there are ongoing
studies of several institutes amongst the ones you mentioned,
the one at the University of Rochester, which attempt to look
at hair, urine, serum levels of children having received a
thimerosal and mercury derivatives, of children having received
immunizations, those who have had thimerosal containing
vaccines and those who haven't.
Preliminary data, as you were told yesterday, shows no
difference in blood levels. I do not have at this point in time
the complete analysis, because it hasn't been completed.
There are also studies at several centers that are looking
at the pharmacokinetics, the metabolism, the disposition and
the disposition in tissues such as brain of mercury when
administered as thimerosal, mercurial mercury in monkeys. There
are another set of studies that have been funded in November
2000 that are carrying out somewhat similar experiments in
rats. These again look at the cellular distribution patterns of
mercury in tissue, including the brain, and also are attempting
to evaluate the role of immune activation in altering brain
levels of mercury after exposure to thimerosal.
The last comment that I'll make in a general way is that as
you know, the Children's Health Act authorized a longitudinal
study to investigate basic mechanisms of environmental
disorders and environmental factors, both risk and protective,
that influence health and developmental processes.
In the context of environment, one is talking about
chemical, physical, social behavioral influences on children
who have critical windows of vulnerability during development,
during which time environmental exposures could have a greater
influence and diseases of increasing prevalence, such as autism
and asthma, are two targeted elements of this. Planning for
this study, which will follow about 100,000 children across the
United States from birth into adulthood, is currently underway,
with pilot studies scheduled to occur in fiscal year 2002.
The other comments I was going to make related exclusively
to the efforts of the NIH to increase its dialog with the
parents and the public community with regard to what our
priorities should be, how we conduct our research as it relates
specifically to autism. The only thing to highlight there is as
a consequence of those efforts, there is a list server
presently available that provides up to date information about
autism related research activities at the NIH, there is an NIH
Web page which also allows you to identify all the research
that presently is funded by NIH and gives you information about
advocacy groups, the scientific literature, etc.
In closing, we at NIH understand the passion of parents and
families of those who have been affected by autism and related
disorders and share your concerns for quickly unraveling the
mystery of autism. Thank you, Mr. Chairman.
[The prepared statement of Dr. Rennert follows:]
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Mr. Burton. Dr. Midthun.
Dr. Midthun. Mr. Chairman and members of the committee, I'm
Dr. Karen Midthun. I'm the Director, Office of Vaccine Research
and Review of the Center for Biologics Evaluation and Research,
FDA. With me today are Dr. Susan Ellenberg and Dr. Norman
Baylor. Dr. Susan Ellenberg is Director of the Office of Vital
Statistics and Epidemiology, and Dr. Norman Baylor is the
Associate Director for Regulatory Policy in the Office of
Vaccines.
Mr. Chairman, as a physician and a parent, I want to
express to you, the members of this committee and to parents
that I'm aware of the devastating effects of autism on children
and their families. I'm here to assure you that we are working
diligently to ensure that the vaccines we license for use in
the United States are shown to be safe, pure and potent. I
appreciate the opportunity to participate in this hearing on
autism and to respond to the committee's concerns regarding a
potential link between vaccines and autism.
The Office of Vaccines regulates the investigation and
licensure of vaccines. FDA's regulatory process for licensing
vaccines has for decades served as a model for other countries.
To date, the existing data do not demonstrate a causal
relationship between vaccines and autism. However, I want to
assure this committee, the public and especially parents that
FDA takes these concerns seriously.
One concern that has been raised relates to the use of
thimerosal, a mercury compound as a preservative in some
vaccines. FDA recognizes and supports the goal of reducing
exposure to mercury from all sources. Consistent with this
goal, for several years, FDA has encouraged manufacturers to
develop new vaccines without thimerosal as a preservative, and
to remove or reduce the thimerosal content of existing licensed
vaccines.
Initial results of this effort were realized at least a
year prior to the enactment of the FDA Modernization Act of
1997, with the licensure of new thimerosal-free vaccines. As
required by Section 413 of FDAMA, FDA conducted a review of the
use of thimerosal in childhood vaccines. A review revealed no
evidence of harm caused by thimerosal used as a preservative in
vaccines except for local hypersensitivity reactions.
Under the U.S. recommended childhood immunization schedule,
the maximum cumulative exposure to mercury from thimerosal at
the time of this review in 1999 was within acceptable limits
for the methyl mercury exposure set by FDA, the Agency for
Toxic Substances and Disease Registry and the World Health
Organization. Of note, all these guidelines contain a safety
margin and are meant as a starting point for evaluation of
mercury exposure, not absolute levels above which toxicity can
be expected to occur.
However, during the first 6 months of life, cumulative
exposure to mercury in some cases could have exceeded the more
conservative limits of the EPA depending on the specific
vaccine formulations used and weight of the infant. The
clinical significance of exceeding EPA's limits is not
currently known. Nevertheless, reducing exposure to mercury
from vaccines is warranted and achievable, in part because in
the United States, it is possible to replace multi-dose vials
with single dose vials, which do not require a preservative.
I am pleased to be able to report substantial progress in
the efforts to reduce thimerosal exposure from vaccines. At
this time, all routinely recommended licensed pediatric
vaccines being manufactured for the U.S. market contain no
thimerosal or contain only trace amounts in the final
formulation. Prior to the recent initiatives to reduce or
eliminate thimerosal from childhood vaccines, the maximum
cumulative exposure to mercury by routine childhood
immunizations during the first 6 months of life was 187 and a
half micrograms. With the newly formulated vaccines, the
maximum cumulative exposure during the first 6 months of life
will now be less than 3 micrograms of mercury, more than a 98
percent reduction.
In an effort to better characterize any toxicity that could
have accompanied an exposure to thimerosal from vaccines, FDA
is in the process of nominating thimerosal to the National
Toxicology Program for further study.
Reports of developmental delay following vaccination have
been submitted to the Vaccine Adverse Event Reporting System
[VAERS]. Although VAERS reports by themselves usually cannot
establish a causal relationship between a vaccine and an
adverse outcome occurring after vaccination, further study of
these reports can sometimes provide important clues and suggest
directions for further research.
FDA takes these reports seriously and has begun a followup
study of VAERS reports of autism. In addition, FDA is pursuing
research involving the characterization and development of an
animal model for autism. While looking at ways to improve the
safety of vaccines, we must keep in mind that childhood
vaccines have contributed to a great reduction in vaccine
preventable diseases, including polio, measles and whooping
cough.
Today, it is rare for American children to experience the
devastating effects of vaccine preventable illness. However,
vaccines, like all medical products, are not risk free, and FDA
is committed to continuing its efforts to reduce these risks
whenever possible.
In conclusion, FDA continues to work diligently with
manufacturers to eliminate or reduce exposure to mercury from
thimerosal in vaccines. As stated previously, at this time, all
routinely recommended licensed pediatric vaccines being
manufactured for the U.S. market contain no thimerosal or
contain only trace amounts in the final formulation.
Although no causal relationship between vaccines and autism
has been established, FDA, along with other Health and Human
Service agencies, continues to pursue research activities to
increase our understanding of any potential relationship
between vaccines and neurodevelopmental disorders. Although the
prevention of disease through the use of vaccines is a
tremendous public health accomplishment, there is more work to
be done. I assure you that the Office of Vaccines at FDA will
continue to make regulatory decisions or recommendations
regarding vaccines based on the best scientific evidence to
protect the public health.
Mr. Chairman, I appreciate the committee's interest in this
area, and look forward to continuing to work with you on this
in the future.
[The prepared statement of Dr. Midthun follows:]
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Mr. Burton. Thank you.
Dr. Boyle.
Dr. Boyle. Good morning, Mr. Chairman and members of the
committee. I'm Dr. Colleen Boyle, Acting Associate Director for
Science and Public Health in the newly established Center on
Birth Defects and Developmental Disabilities at the Centers for
Disease Control and Prevention.
I have with me today Dr. Roger Bernier, an epidemiologist
and Associate Director of Science for the National Immunization
Program at the CDC.
Thank you for the opportunity to update you on CDC's
activities related to autism. One major change since last year
is that CDC has established, at the direction of Congress, a
new center, the National Center for Birth Defects and
Developmental Disabilities. This center will increase CDC's
efforts to discover causes and develop preventive strategies
for birth defects and developmental disabilities, including
autism.
First, Mr. Chairman, I want to stress that CDC is committed
to understanding the prevalence of autism, identifying its
preventable causes and establishing and evaluating prevention
programs. We've made considerable progress over the last year
toward fulfilling this commitment. Last year, we mentioned that
CDC and the Agency for Toxic Substances and Disease Registry
were about to report on an investigation on the prevalence of
autism in Brick Township, NJ. The investigation found a rate in
Brick that is high compared to many previous studies.
However, there are few very recent studies, none in the
United States, that have reported rates in this range, which
suggest that the rate of autism may be considerably higher than
previously thought. To increase our ability to monitor autism
prevalence in the United States, in September 2000, CDC
competitively funded health departments in Arizona, South
Carolina, Maryland and New Jersey to establish monitoring
programs for autism in their States.
CDC is also completing the analysis of the first year of
autism monitoring data gathered from its own metropolitan
Atlanta developmental disability surveillance program. Our
report should be complete later this year.
This September, as directed by Congress, CDC will
competitively fund up to four centers of excellence in autism
epidemiology to conduct collaborative epidemiologic studies.
The research objectives of these studies will be determined by
an independent oversight committee, and representatives from
parent and consumer groups will be invited to provide input to
the oversight committee in planning the epidemiologic study.
CDC has also developed a wide range of activities that are
responsive to the needs of parents of children with autism and
health care professionals working with these children. For
example, CDC funds a program at Marshall University in West
Virginia of an intensive community support program for families
with young children with autism. As part of the centers for
excellence in autism and epidemiology, we expect to fund
projects of model intervention programs for children with
autism, of the economic and social costs of autism, and of
studies to look at the natural history of autism.
Some parents have expressed concern about the potential
link between autism and vaccines. Although the weight of the
scientific evidence does not support such a link, CDC is
committed strongly to assuring vaccine safety. The concerns
raised regarding autism and vaccines have focused primarily on
thimerosal, a preservative in some vaccines, and on the
measles, mumps and rubella vaccine. Today, all manufacturers
are producing for immunization only vaccines that are free of
thimerosal or have only trace elements of thimerosal.
As shown in figure one of my testimony, the thimerosal
content of pediatric vaccines purchased by States through CDC's
contract has dramatically decreased since 1998. CDC is actively
investigating whether there have been any adverse effects
related to thimerosal in vaccines. Preliminary analyses of the
vaccine safety data link have not supported a link between
thimerosal containing vaccines and autism.
It has been suggested that vaccination, particularly with
the MMR vaccine, may be related to the development of autism.
Substantial scientific review does not support this suggestion.
First, the American Academy of Pediatrics executive committee
stated in March 2001 that there is a considerable body of
evidence that does not support a causal relationship between
MMR vaccine and autism or inflammatory bowel disease. Second,
the IOM stated just this week that existing evidence does not
favor a causal relationship between the MMR vaccine and autism.
In addition, Dales et al. recently reviewed changes over
time in the MMR coverage and autism diagnoses in California.
There was a 373 percent relative increase, in the prevalence
rate of autism between 1980 and 1994 while the MMR immunization
coverage was relatively flat over that same period.
To date, the weight of the scientific evidence does not
support a causal relationship between vaccines and autism.
Nevertheless, because of the continuing concern of parents, we
are committed to conducting research to evaluate this matter.
At present, we are conducting a study in Atlanta, another in
Denmark, and we are collaborating with NIH, with their centers
and programs of excellence in autism to further examine the
relationship between vaccines and autism.
While we must remain vigilant to assure the safety of
vaccines, we must also remember that vaccines benefit the
individual child and the public by protecting persons from the
consequences of infectious diseases. While we've made great
progress to reduce the number of cases of vaccine preventable
diseases, threats posed by vaccine preventable diseases are
known and are real.
We want to assure you that CDC knows how important it is to
find the causes of autism and prevent this disorders. We are
committed to conducting research that will lead to these
answers. With the support of Congress, we have made a good
beginning by funding autism monitoring programs with several
States and the Centers of Excellence in Autism Epidemiology to
look at causes of autism. CDC's efforts will continue until we
have found the answers that will enable us to prevent this
serious condition that affects so many American children.
Thank you, Mr. Chairman and members of the committee, for
the opportunity to testify before you today. Dr. Bernier and I
would be happy to answer any questions that you may have.
[The prepared statement of Dr. Boyle follows:]
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Mr. Burton. I neglected to have you sworn. Would you all
please stand?
[Witnesses sworn.]
Mr. Burton. Dr. Boyle, why is it that there's a reduction
in thimerosal in vaccines that are being produced today? Did
not our health agencies request that thimerosal be removed from
vaccines as the newly produced vaccines?
Dr. Boyle. I think we've made considerable progress in
reducing the thimerosal content.
Mr. Burton. So you've asked that thimerosal be reduced in
vaccines, have you not?
Mr. Bernier. I think the answer is that this was done as a
precautionary measure.
Mr. Burton. Why?
Mr. Bernier. Because it was feasible to do, and there are
sources of exposure to mercury that we cannot control, such as
that from food. So----
Mr. Burton. I'm talking about the vaccine. Why is it that
you have started at our health agencies to reduce the amount of
thimerosal in vaccines, as a precautionary measure?
Mr. Bernier. As a precautionary measure.
Mr. Burton. OK, as a precautionary measure. That would lead
one to believe that you're not really sure whether or not
thimerosal causes some problems. Otherwise, why wouldn't you
just leave it in there and say, hey, we've run all these tests,
there's no causal link whatsoever? So why even move to take it
out of there?
Mr. Bernier. There is a theoretical risk.
Mr. Burton. OK, so there's a theoretical risk. Then why
have we not recalled the vaccines that have thimerosal in them
right now, while you're testing this? If there's any question
whatsoever about what we're putting into our kids' arms, and
their bodies, and if you're reducing thimerosal because you
think there may be a causal link, as a precautionary measure,
why don't you recall the thimerosal that's in doctors' offices
that are being injected into kids as we speak until you're
sure? Because obviously you're not sure or you wouldn't be
taking it out anyway. Why don't you recall it?
Mr. Bernier. I can give you my comments. The FDA may wish
to weigh in on this issue of recall. But as succinctly as I can
put it, Mr. Chairman, being safe means being safe from disease
as well as being safe from the side effects of vaccine.
Mr. Burton. Let me ask you this question, then. Can you
create a measles vaccine and do we have a measles vaccine that
does not have thimerosal in it?
Mr. Bernier. Yes, that's correct.
Mr. Burton. Can we create a mumps vaccine that does not
have thimerosal in it?
Mr. Bernier. That's correct.
Mr. Burton. Then why are you putting thimerosal in it?
Mr. Bernier. At the present time, as Dr. Midthun and Dr.
Boyle mentioned, we have made very good progress, and I can say
to you we are not putting in thimerosal any longer in the
vaccines that are being produced.
Mr. Burton. So if you're not, if you're not, as a
precautionary measure, then why are you leaving vaccines on
doctors' shelves and in drugstores around this country that are
being used in facilities where they supply them, are being
used, if you're not putting them in new vaccines, as a
precautionary measure? Why don't you recall the supply that you
have out there until you are absolutely sure, beyond any doubt,
that thimerosal has no causal link to autism? Why don't you
recall it?
Dr. Midthun.
Dr. Midthun. Under the Public Health Service Act, in order
to make a mandatory recall of vaccine, there has to be an
imminent or substantial hazard to the public health. As the
weight of the evidence does not support a causal link between
thimerosal----
Mr. Burton. Then why are you taking it out of the new ones?
Dr. Midthun. As Dr. Bernier said, it's a precautionary
measure. It's recognized that mercury in large doses is toxic
and any way that we have of reducing the exposure to mercury
over which we have control is something that is desirable to
do.
Mr. Burton. Let me tell you, my grandson was very healthy
and very normal and spoke and ran around like every other
child. He got nine vaccines in 1 day. He got 41 times what's
the allowable amount of mercury through thimerosal in 1 day.
And 10 days later, we lost him. Now, we're trying to get him
back.
Now, there's a lot of parents out there that are getting
all these shots when their children's immune systems are
depressed, they've got colds, and they're getting these shots,
several of them at a time, with thimerosal in them. As a
precautionary measure, if you think there may be a causal link,
don't you have any latitude whatsoever to recall those and say,
we're not going to destroy this, but we're going to hold these
supplies in abeyance until we know for sure, until all the
tests have been done?
Dr. Midthun. Not under the Public Health Service Act.
That's not what would allow us to make a mandatory recall.
Mr. Burton. But you are taking thimerosal out of vaccines,
as a precautionary measure?
Dr. Midthun. That's correct.
Mr. Burton. How long are these studies going to take, Dr.
Rennert?
Dr. Rennert. We hope to have answers of various phases
within the next 2 to 3 years.
Mr. Burton. Oh. Do you know how many kids are going to be
vaccinated today? Do you know that in California, it used to be
one child every 6 hours was becoming autistic. It's now one
every 3 hours. In the United States, 1 out of 400 to 500 kids
are autistic. And in some parts of the country, it's under 200.
And boys have a four times more prevalence of getting autism
than girls.
So if you go to Oregon, 1 out of 190 kids are autistic,
that means 1 out of 50 boys being born are going to be
autistic. And you're telling me these studies are going to take
2 to 3 years, and at the same time the studies are going to
take 2 to 3 years, you're going to keep mercury in vaccines
that you just saw from that Calgary, Canada study what mercury
does to brain cells?
I mean, come on. If there's any doubt whatsoever, and you
say it's a precautionary measure you're taking, then why in the
heck don't you get that stuff off the market until you've
tested it thoroughly? And if it's going to take 3 years, put it
some place for 3 years, in a storage box, and if the tests
don't prove out, you've still got it, and the pharmaceutical
companies can still get their money.
Now, on these tests that you're doing, you said you're
testing the blood for mercury. Are you testing hair and urine
samples?
Dr. Rennert. Yes. In the studies that were done by Navy and
the University of Rochester, there are samples that have been
obtained for study of hair and urine concentrations as well.
Mr. Burton. Have you had any results from that yet?
Dr. Rennert. No, sir. The study as far as I know has just
been completed and the analysis is occurring. I don't have the
data.
Mr. Burton. How long will it take to get that analysis?
Dr. Rennert. I would imagine--to be honest, sir, I don't
know. I don't think it will be long, but I will attempt to find
out and give you an answer.
Mr. Burton. We would like to have copies of the analysis as
quickly as you get them. We'd like to have any records that you
have whatsoever about the analyzing of blood, hair, urine,
whatever it is, regarding mercury and thimerosal in these kids.
You know, you were talking about how vaccines have reduced
measles, mumps, rubella, diphtheria, all these other things.
And that is great. And we really appreciate what vaccines and
pharmaceutical companies have done for this country. Because
they've saved a lot of lives. And what you've done has been
very laudable.
But when you have a child who is autistic, from the time he
becomes autistic until he dies, they estimate that the cost to
our society is $5 million, for each child. Now, if we have 1 in
400, and the cases are rising at a very rapid rate, do you have
any idea what that's going to do to our economy? Not now, but
5, 10, 15, 20 years from now. And so every precaution that
should be taken must be taken and must be taken now. Because
this is not only a health issue, it's an economic issue that's
not going to go away.
I mean, we're talking about trillions and trillions of
dollars if we don't find an answer. If you've got substances,
aluminum, formaldehyde, mercury, in these vaccines, and you
have this huge rise and you're not absolutely sure that
mercury's not causing it, you ought to get it out of there. You
ought to recall this stuff. Because the doctor just said, Dr.
Bernier just said that they are producing and can produce
vaccines without mercury in them, without thimerosal.
Now, granted, you might not be able to put three or four
different vaccines in one vial. Because as I understand it, you
put the mercury in there to keep everything pure so they can be
used, and won't be tainted. But if you go to single vials with
single vaccines, sure, the parents would have to have more
shots. But if it's going to be safer, then why not do it? And
why wait 3 years for studies if you think that there may, even
the most remote possibility, be a causal link.
If you look at some of these studies, like we've seen, and
I am not a scientist, I'm not a doctor, I'm just a grandfather
who has an autistic kid, and I didn't even know what autism was
until a couple of years ago. But when you see the huge number
of people that are contacting us through e-mail and through
conferences, there's one going on right here, you've got to
take the proper precautions. You can't say, let's wait 3 years
and let this go on.
So as I said earlier, and I'm going to yield to my
colleagues here, as I said earlier, we have 113 members in the
Autism Caucus. They will be supplied with every bit of
information we get, not only from you folks, but from Calgary,
Canada, and from around the world and from the experts we have
here. And I will be taking special orders on the floor of the
House. I'll be going down there on a regular basis, reading
into the record and talking to the American people, about the
problems that we have.
So the pressure that you're feeling, if any, now, I don't
know if you are or not, but the pressure you're feeling right
now is going to be magnified as many times as I can make it,
until our health agencies either come to some conclusion that's
scientifically provable, or they get that stuff out of there,
in particular thimerosal. And I don't know why, if you're
coming up with vaccines that don't have these toxic substances
in them, as I believe they are, I don't understand why you
don't recall that stuff. Get it off the market.
FDA, can you do a voluntary recall for manufacturers the
same as the rotavirus recall?
Dr. Midthun. That was not a voluntary recall. The
manufacturer on their own initiative withdrew their product
from the market.
Mr. Burton. Can you contact the people that manufacture
thimerosal, and I know who it is, can you ask them to recall it
temporarily?
Dr. Midthun. That would be something that would be
voluntary on their basis.
Mr. Burton. You can't write them a letter and say that
because of the concern of thousands and thousands of parents
and because we're in the process of doing research on this, we
think it would be prudent to recall thimerosal products until
we run all of our tests, which may take as much as 3 years?
Dr. Midthun. I'm sure that the companies are well aware
also of these concerns over autism----
Mr. Burton. But you can't even write them a letter?
Dr. Midthun. It's their choice to make a voluntary recall,
and they know that they have that choice, sir.
Mr. Burton. So you're not going to do anything?
Dr. Midthun. Under the PHS Act, we can make a mandatory
recall for the reasons that I indicated. And the company, of
course, on its own volition, can do anything it would like in
terms of making product available or deciding not to distribute
it any longer.
Mr. Burton. I found out yesterday that there's a lawsuits
pending, I believe in, I think it's Mississippi, regarding
mercury toxicity and how it's affected children. And if that
lawsuit is successful by the people who are bringing the suit,
it will probably involve a great deal of money to the
pharmaceutical company that produces this product, and other
pharmaceutical companies that use it in their vaccines.
I wonder, I just wonder if perhaps one of the reasons why
FDA is not pounding these pharmaceutical companies to get this
off of the market, especially when you look at this Calgary
study about mercury and the toxicity of it, maybe there's not
pressure being exerted by pharmaceutical companies on our
health agencies because they're afraid of what might happen in
that lawsuit if they do withdraw it from the market. Is there
any validity to that kind of thinking?
Dr. Midthun. I really couldn't say. I do not know, sir.
Mr. Burton. OK, Mr. Gilman.
Mr. Gilman. Thank you, Mr. Chairman. I want to thank you
for raising these issues.
Permit me to request that my opening statement be made part
of the record.
Mr. Burton. Without objection.
[The prepared statement of Hon. Benjamin A. Gilman
follows:]
[GRAPHIC] [TIFF OMITTED] T6856.267
[GRAPHIC] [TIFF OMITTED] T6856.268
[GRAPHIC] [TIFF OMITTED] T6856.269
Mr. Gilman. And I do have several questions. I think what
Chairman Burton is raising I think is quite pertinent. I'm
surprised to hear that, Dr. Midthun, you're reluctant to issue
any letter to the manufacturers if there is some concern. You
say there is some mandate in the legislation that permits you
to make some of these corrections?
Dr. Midthun. Under the PHS Act, the FDA can make a
mandatory recall if there is an imminent or substantial hazard
to the public health. And as I noted before, the preponderance
of the evidence does not suggest that there was a causal
relationship between thimerosal containing vaccines and autism.
Thus, there is no substantial or imminent hazard that would
authorize us to make a mandatory recall, sir.
Mr. Gilman. And yet, you are making a request that the
thimerosal not be included in the future production of vaccines
because of some concern? Is that correct?
Dr. Midthun. As Dr. Bernier noted, wherever it is possible
to reduce exposure to mercury, that is a goal that we would
like to achieve. Because there are many aspects of exposure
that we don't have control over. For example, environmental
food intake and thus, it's considered a precautionary measure
that we can take. It's achievable, we can move from multi-dose
vials that require a preservative to single dose vials. That's
what we have been doing, and actually have made a substantial
achievement toward reaching, as I noted before, currently all
vaccines being manufactured for pediatric use under the routine
childhood immunization schedule, either contain no thimerosal
or only trace amounts.
Mr. Gilman. And that's based on your recommendations?
Dr. Midthun. That's based on working collaboratively
together with the other public health service agencies and also
the manufacturers, that it was agreed that this would be an
achievable goal, and it would be good to reduce the exposure to
mercury whenever possible.
Mr. Gilman. So there is a consensus in the thinking of the
medical world that it would be preferable to eliminate that
possibility in providing vaccines for children, is that
correct?
Dr. Midthun. It's recognized that mercury in larger amounts
is a toxin. And thus, it is good to be able to reduce exposure.
You can never eliminate exposure. But it is good, where you
can, to be able to reduce it.
Mr. Gilman. I will yield.
Mr. Burton. Let me just ask, is mercury a cumulative thing
in the body?
Dr. Midthun. I'm not a toxicologist.
Mr. Burton. We had one yesterday. And the toxicologist, Mr.
Gilman, said that if you get a shot with mercury in it and then
you get another one and another one, there's a cumulative
effect. And our children are getting 26 shots by the time they
go to school.
I might add, did you get a flu shot?
Mr. Gilman. Yes, I did.
Mr. Burton. You got thimerosal. You got mercury in your
body from that shot, and Dr. Eisel, our admiral, I called him
about it, and he didn't even know it was in there.
Mr. Gilman. That raises another good question. You have
taken some precautionary measures. What have you done with the
public so that they're aware of these problems? What is your
educational process, what have you done in the educational
process to the consuming public with regard to these concerns
that you have in the medical community?
Dr. Midthun. Our labeling for products indicates what is in
the product. In the case where there is a preservative, it is
so stated. And----
Mr. Gilman. I'm not asking just labeling. I'm asking you,
have you undertaken educational initiatives for the consuming
public so they'd be aware of these problems?
Dr. Midthun. We believe that the vaccines are safe and
effective, including those vaccines that were licensed with
thimerosal as a preservative, sir.
Mr. Bernier. Mr. Gilman, if I might add something, because
we've discussed this at CDC in anticipation that we might have
this question. I think one of the things that CDC has done, at
least, is we generally try to work with the provider community
to try to provide information about these matters. So in the
last 22 months, during the time when this episode has been
ongoing, there have been repeated publications, for example, in
the morbidity and mortality weekly report at CDC, there have
been joint statements between the Government agencies and the
American Academy of Pediatrics and the American Academy of
Family Physicians.
So we have worked to put information in the hands of the
providers, so that they could address the concerns of the
parents. Also, we have had on our Web site information about
these matters. We have a hot line where parents can obtain
information. So I wouldn't want to leave the impression that we
haven't been proactive, if you will, about putting information
out there. Because I think we have been.
Mr. Gilman. Well, you're saying you're putting it in the
hands of the providers. What about the consuming public? What
are you doing? You're a government agency. What are you doing
about educating the public about these dangers? What has been
done by your agency or any of the panelists who are here
representing our government agencies? What's been done to make
the consuming public aware of these mercury problems?
Mr. Bernier. Well, like I said, at least speaking for CDC,
traditionally we make, we work through the providers to address
the concerns of the parents to make sure----
Mr. Gilman. You don't go beyond the provider? If the
provider fails to make the information available, you're
satisfied?
Mr. Bernier. Well, we have also the vaccine information
statements that parents are given prior to vaccination, and
that's one direct connection that we have with the parents at
the time of vaccination.
Mr. Gilman. Are these statements that your agency makes to
the parent?
Mr. Bernier. Are they what, sir?
Mr. Gilman. Are these statements that you make available to
the parent?
Mr. Bernier. Yes.
Mr. Gilman. How is that distributed?
Mr. Bernier. These are widely available, they're required
by law to be made available to all the parents when children
are immunized, before every immunization----
Mr. Burton. If the gentleman would yield.
Mr. Gilman. I'd be pleased to yield.
Mr. Burton. And then we'll get to Dr. Weldon.
Mr. Gilman, do you ever use a nasal spray?
Mr. Gilman. No.
Mr. Burton. Does your wife, or any of their friends?
Mr. Gilman. My wife does.
Mr. Burton. Do you know that most nasal sprays have
thimerosal in them?
Mr. Gilman. I didn't know that.
Mr. Burton. Yes. There's mercury in a great many products
that we use as adults. And there's a tremendous rise in the
number of cases of Alzheimer's. And mercury has a debilitating
impact on the brain, as you saw, you probably didn't see it, in
that Calgary study. So it's not only the children that are
being affected by this, in my opinion. And I'm not a scientist.
It's all of us.
Because we're getting mercury through the environment, but
we're getting it in nasal sprays, and the health agencies, not
too long ago, took mercury out of all topical dressings,
because they said it would leach into the skin and cause
problems. And yet, it's in nasal sprays, it's in a lot of
products we use as adults, and it's in our vaccinations, like
the flu shot that you received.
Mr. Gilman. Mr. Chairman, if I might reclaim my time. It
would seem to me there's a responsibility by our agencies,
whether it be NIH, whether it be CDC, whatever agency is
involved in regulating our vaccines, that we make more
information available to the public of the dangers of mercury,
and make it available not only just to potential users of the
vaccine, but to the entire public.
So I'm urging those panelists who are here today to address
that problem, since it is a problem that can affect millions
and millions of our population.
Just one other question, Mr. Chairman. Parents are becoming
concerned about the vaccines that are already on the market
that have not been recalled, but many are unaware what's being
done to make some recall or are unaware of your preventive
actions or your concerns, because you have directed the
manufacturers to take some steps to remove this product.
But what have you done with the product that's still on the
shelves around the country?
Dr. Midthun. It remains on the shelves, sir.
Mr. Gilman. And could be used?
Dr. Midthun. And could be used, that's correct.
Mr. Gilman. Shouldn't you have some responsibility to
remove that, if you are concerned about its use?
Dr. Midthun. Again, as I mentioned, there are certain
conditions that allow us to make a mandatory recall. And that
is not one of them. You have to have an imminent or substantial
hazard to the public health in order to make a recall.
Mr. Gilman. Are you concerned that if some of these
products are used, they could cause some problems in the health
of young people?
Dr. Midthun. The evidence does not show that there is a
causal relationship between thimerosal as used in vaccines and
autism.
Mr. Gilman. And yet you recommended that it not be used in
future manufacturing, is that correct?
Dr. Midthun. That's correct, because if we can decrease
exposure to mercury in ways that are available to----
Mr. Gilman. If you're concerned about the increase in
exposure, then why not take these products off the shelves and
prevent their distribution? If you really are sincerely
concerned about the use of these products, it would seem to me
there's an absence of responsibility here by your agency.
Dr. Midthun. We have to follow the regulations as they are
written, sir.
Mr. Bernier. Mr. Gilman, could I add, I want to, I think,
try to correct an impression that I think is being generated
here. That is that the vaccine is not being recalled then
nothing's happening. I think nothing could be further from the
truth. Please allow me to just take a minute to explain what
has changed between, in the last 22 months and today. And a lot
has changed.
I think the impression is, well, if we don't accomplish a
recall that somehow this problem is not being addressed. And I
think there are two or three things I'd like to point out.
Mr. Gilman. Doctor, if I might interrupt, when we have
faulty tires on vehicles, we demand that they be recalled. If
we have a medication that's on the shelf that could create some
problem, it would seem to me there's enough evidence, even
though it's not fully explored, that there's enough evidence
available that these products should not be allowed to go out
to the consuming public.
Mr. Bernier. Mr. Gilman, we have no faulty vaccines on the
shelves.
Mr. Gilman. You've already testified before us, at least
Dr. Midthun has testified that as a preventive measure, they're
recommending to the producer not to use this product. It would
seem to me that's enough evidence to take the rest of the
product off the shelf.
Dr. Midthun. We've not recommended that a product not be
used. We have worked with manufacturers to reduce the use of
thimerosal as a preservative in vaccines.
Mr. Gilman. And you've done that because you have a concern
about the future health of young people, isn't that correct?
Dr. Midthun. We have concerns about overall exposure to
mercury from all sources in the environment. And this happens
to be a source that we can control by switching to single dose
vials in large part.
Mr. Gilman. And these other products that are still on the
shelf could contribute to their poor state of health, is that
right?
Dr. Midthun. We do not believe that the products out there,
we believe that they are safe products, sir.
Mr. Gilman. No further questions.
Mr. Burton. Dr. Weldon.
Dr. Weldon. Thank you, Mr. Chairman. I want to thank all
the witnesses for testifying. I certainly thank your efforts in
trying to answer and address the issues and concerns we have.
Dr. Rennert, you testified, I believe, that the total
spending at NIH will be $52 million on autism related research?
Correct me if I'm wrong, that is including a lot of autism
related research, but the actual figure on autism specific
research is smaller than that, is that correct?
Dr. Rennert. I can't tell you that for sure. I will tell
you that the list we submitted is correct. We will go back and
review it and provide you with the information.
Dr. Weldon. Yes, I would like you to personally provide
that to me, because I have had people come to me and say the
net was cast pretty wide to come up with a figure that high,
and that the figure for autism specific research is actually
about a third or less of that.
And the reason I bring that up is, I had my staff pull a
Congressional Research Study on AIDS. The figures that were
provided to me from CRS is that there's 300,000 Americans
currently suffering with AIDS, and 115,000 living with HIV.
Now, I realize some people estimate that those figures are
quite a bit higher, and that there's a substantial cohort in
the population who have exposure to HIV, they're carrying HIV
and they don't know it.
But if we use those figures and those figures have appeared
in the media, that's about 415,000 people. The Federal
expenditures on research and treatment and the various care for
those patients with AIDS is $10.9 billion. Now, if we just look
at the research number, I have a figure of $3.1 billion in the
year 2000. I could not get the 2001 figure.
Now, I'm told we have about a similar number of kids with
autism. That's also very debatable, if you look at autism
spectrum disorder, you get a much larger number. When I do the
math, it comes out to, for research, about $7,000 per person
with AIDS and about $140 for each child with autism. Another
way to look at that figure is for every $7 we spend on AIDS
related research, we're spending 14 cents on autism related
research.
Do you, and I would ask any of the panelists to comment on
this, do you feel that, and I feel the ultimate responsibility
for this rests with the Congress, not with you, OK? So I'm not
trying to make you feel bad. I think we have a responsibility
to make sure that our money is spent, or the public's money,
the taxpayer money, is spent appropriately. Do you think this
is an appropriate level of funding, a relatively appropriate
level of funding?
Dr. Rennert. You've evoked my bias as a pediatrician. I
believe our future is with our children. What I can tell you is
that we will spend more money on autism research. The numbers
that I've presented, regardless for the moment of the
magnitude, represent an increase in funding at least in recent
times, for this area. And I certainly subscribe to the notion
that this is an area that should be an area of focus and
emphasis for us.
Dr. Weldon. Well, does anybody else want to comment?
Dr. Boyle. Sure, I'd be happy to.
Dr. Weldon. Are there adequate levels of funding for the
types of research studies that need to be done on this?
Dr. Boyle. We direct money at CDC as directed by Congress.
But I can tell you that in the last year, we have gotten a
substantial increase in our funding for autism. And that's
really allowed us to develop the State surveillance, State
monitoring programs that I referred to in my testimony. It's
allowing us to develop the infrastructure to actually be doing
a very large study of the epidemiology of autism.
So I feel that we have made substantial progress. But we
have a lot further to go.
Mr. Gilman. Would the gentleman yield?
Dr. Weldon. I'd be happy to yield.
Mr. Gilman. Have any of you made a request for additional
moneys that have not been allocated for your autism research?
Have any of your agencies made a request for additional sums in
the budget that were not allocated to you? Or were you all
satisfied with the way the funds were being allocated?
Dr. Weldon. If I could ask it a different way, were all of
your requests granted to you by your superiors within the
agencies you work in?
Dr. Midthun. May I just say that FDA, and the Office of
vaccines, we don't have the ability to ask for funding for
studying autism per se. Our mission is to regulate vaccines.
Dr. Weldon. What about CDC and NIH?
Dr. Rennert. The answer for NIH is no.
Dr. Weldon. We'll make sure your future is secure in the
year ahead.
Dr. Boyle, I've got to ask you a question related to what
you're doing. We had a physician testify yesterday about this
increasing incidence issue. And I think you came into my office
once and we talked about this, and the change in the diagnostic
manual. He made a very good point. Where are all the adults? If
the prevalence isn't increasing, if the incidence isn't
increasing, then where are all the adults? In all of these
studies, you're looking at prevalence and incidence. Are you
looking at prevalence in adults to try to make a determination
to answer that question, is the rate increasing?
Dr. Boyle. Our studies have been directed at children. We
primarily look at school age children, children age 3 to 10.
That is a very good question. And as may have come up
yesterday, the prevalence, we call it prevalence only because
we think most of it has to do with sort of prenatal etiology,
so that someone is either born with the condition or with the
specific genetic predisposition for the condition. So we
thought we'd refer to prevalence.
Dr. Weldon. Well, I would recommend you look at that issue,
looking at the disease prevalence throughout all age groups in
the population. Because I think that's a very, very critical
question, if we are going to try to get----
Dr. Boyle. I think Dr. Amaral testified yesterday about
efforts in California to address the issues of sort of changes
in diagnosis, as many researchers have suggested, as well as
the greater awareness of the condition and the impact that has
had on the increase in the number of cases seen in California.
Actually, I think that's going to be a very interesting study.
It's really going to be able to shed some light on what's
happening.
Mr. Burton. Can we come back to you, Dr. Weldon? Mr. Waxman
is here and he wants to ask a few questions, then we'll come
right back to you.
Mr. Waxman. Thank you, Mr. Chairman.
Dr. Bernier, the CDC has explained that it is opposed to
recalling thimerosal-containing vaccines because it's concerned
about shortages. In fact, I understand there is a concern about
a shortage of DTaP vaccines. At the hearing yesterday, one of
the witnesses suggested that stocks of non-thimerosal vaccines
are adequate and that there was no need to keep thimerosal-
containing vaccines on the shelves.
Can you explain your concerns about shortages? For
instance, if the DTaP vaccine containing thimerosal were
recalled, what possible effect would that have on our children?
Mr. Bernier. Yes, Mr. Waxman, it is correct that at the
present time, for DTaP, there is a very tight supply situation.
We have two additional manufacturers that have left the market
in the recent past, and we are now left with only two
manufacturers. And there are back orders at the present time
that cannot be filled because the amount of available vaccine
is not adequate to fill those back orders.
So if in fact there was to be issued a strong preference
for thimerosal free DTaP, or if there were to be a sudden
recall of the existing DTaP vaccine with thimerosal, this would
produce spot shortages which would create, we think, delays in
children being immunized, which could lead to disease very
quickly.
In 1999 alone, there were 15 deaths from pertussis in the
United States. This year already we've had five deaths from
pertussis. So the need to continue the coverage with DTaP is
very real. These are not hypothetical or theoretical risks. We
know that creating shortages will produce coverage problems,
will increase the risk of children to these diseases.
Mr. Waxman. Last year, CDC testified that they were
actively monitoring possible adverse effects of thimerosal, the
mercury-containing preservative that's being phased out of
vaccines. CDC found no link between thimerosal and
developmental delays. Have you continued to monitor for any of
these effects, and what has your surveillance shown?
Mr. Bernier. Well, we have continued at least in the look
at the autism question. In the original results from the
vaccine safety data link, there was no evidence of a link
between thimerosal exposure and autism. In the last year, an
additional number of cases has accumulated. I believe somewhere
in the vicinity of an additional 40 cases. When we add those
cases to the ones that we looked at before, we reached the same
conclusion. It has not altered the original conclusion, which
was that there was no link between exposure to thimerosal and
autism.
Mr. Waxman. Thank you. Dr. Midthun, at the hearing
yesterday Dr. Haley testified about the toxicity of thimerosal-
containing vaccines. He suggested that the thimerosal in
vaccines was harmful to children.
In the pre-licensure phase, is the vaccine tested for
toxicity?
Dr. Midthun. Yes, it is. The vaccines are usually evaluated
in a very large number of infants, if that's the target
population for whom they're intended. They are tested with
regard to the entire formulation. And thus, if there were to be
any acute toxicity, that would be noted in the clinical trials
that are done in support of the license application.
Mr. Waxman. Does this mean that the entire vaccine,
including all of its component parts, is tested for toxicity?
Dr. Midthun. That's correct. The vaccine in entirety is
tested.
Mr. Waxman. So if a vaccine were toxic, this should be
revealed in the prelicensure phase, is that correct?
Dr. Midthun. Yes, that's correct.
Mr. Waxman. What did the toxicity testing of vaccines with
thimerosal reveal? Did this testing indicate that the
thimerosal is likely to pose health dangers for children?
Dr. Midthun. The clinical studies did not suggest that,
sir.
Mr. Waxman. So why did the FDA move quickly to remove
thimerosal from vaccines?
Dr. Midthun. Because we felt it was an achievable goal. It
was a way where we could reduce the overall exposure to mercury
among children, and it was something that was achievable,
because we could switch from multi-dose to single dose vials.
In the United States that was something that was feasible.
Mr. Waxman. Dr. Boyle, Dr. Wakefield testified at
yesterday's hearing that we need active surveillance of vaccine
adverse events. Can you explain what CDC does to actively
monitor potential problems associated with vaccines?
Mr. Bernier. CDC is actively looking at vaccine safety
events through the VAERS system. We are monitoring events and
when events occur that create cause for concern, we have the
resource represented by the vaccine safety data link
population, which is a way of, provides us an easier means of
testing hypotheses that may arise from adverse events that are
detected.
So we have this detection arm and then we have a testing
arm where we can test hypotheses. For example, this was one of
the ways in which it worked recently with rotavirus and
intussusception, where both arms of the vaccine safety
mechanisms were put into play in order to address that concern.
Mr. Waxman. Thank you very much. Thank you, Mr. Chairman.
Mr. Burton. Let me just followup on what Mr. Waxman said. I
know he has to leave and he's probably not going to hear the
response, but did you folks test the rotavirus vaccine before
you put it out on the market?
Dr. Midthun. I've not been involved with the rotavirus
vaccine trials.
Mr. Burton. It was tested by FDA, wasn't it?
Dr. Midthun. It was tested by FDA.
Mr. Burton. And in 9 months it was recalled, wasn't it?
Dr. Midthun. Maybe I could ask Dr. Baylor. I wasn't there
at the time.
Mr. Burton. You don't have to ask him. It was recalled,
because one child died, there were several serious problems,
intestinal problems where there was surgery involved. And it
was recalled.
Dr. Midthun. I just spoke with Dr. Baylor. It wasn't
actually a recall, either a mandatory or a voluntary recall.
The company decided to withdraw it from the market, sir.
Mr. Burton. Well, because one child died, and a whole host
of them were injured. I mean, you know, you can cut it either
way you want to. The fact is, they took it off the market, and
it had been tested. So you folks are not infallible.
Now, the DPAT shot, are they still manufacturing that with
thimerosal in it?
Mr. Bernier. No, Mr. Chairman, they are not.
Mr. Burton. They're not. But you say that they're not
producing enough of the single shot vaccines to take care of
the needs of the country at the present time?
Mr. Bernier. At the present time, there is a shortage in
the supply, correct. They are back ordered, and the new vaccine
that they are producing is not adequate to meet the demand at
the present time.
Mr. Burton. How long will it take for that to be adequate?
Mr. Bernier. I think the FDA could have a better idea of
that. My impression is that it's, well, I mean, relatively
short, and I'm thinking of a few months. But I don't have the
information.
Mr. Burton. So in a few months, they could have the supply
up. Now----
Mr. Bernier. Could we just get FDA, because I don't want
that to be on the record, if that's true or not.
Mr. Burton. How long will it take for them to get the
single shot vials, doses up to safe level?
Dr. Midthun. I can't give you the exact time line. But I do
know that there are two more lots potentially containing
thimerosal that the company intends to release. But after that,
they will then be releasing only the thimerosal reduced
versions.
Mr. Burton. How many shots are in a lot?
Dr. Midthun. That's proprietary information, sir.
Mr. Burton. Do you want me to subpoena it?
Dr. Midthun. I would be happy----
Mr. Burton. You get it for me, or I'll subpoena it. I want
it.
Dr. Midthun. I would be happy to respond to the chairman's
letter on that.
Mr. Burton. Because what we're talking about, there's
thousands and thousands of shots of DPAT that you're going to
put into the system and kids are going to get those shots
because of the shortage.
Now, let me ask you, what's the likelihood, let's say it
takes 6 months, let's say it takes 6 months to get the single
shots up to snuff to where you've got a supply, let's say it
takes 6 months. How many kids do you think are going to die in
6 months because they don't get that shot?
Mr. Bernier. I can't estimate, Mr. Chairman. I can tell you
that as I mentioned earlier in my testimony, this is not
hypothetical. In 1999, there were 15 deaths associated with
pertussis. And already, there have been five deaths this year.
So if we created a situation where we abruptly said, you must
use thimerosal free vaccine, that would create shortages which
would lead to delays which would lead to what I'm calling days
of lost protection.
Mr. Burton. I understand. You've made your point. Let me
just say this. I want the names of the producers of the DPAT
shot. And I'm going to subpoena records from them to find out
how much is in a lot, how they have two more lots that they
have to use, they have two more lots. I want to find out how
long it would take for them to produce the diphtheria, tetanus
and the pertussis vaccines individually. I'm going to find out
how long it's going to take.
Because I suspect that those lots have a lot of shots in
them and there's a lot of money involved, a lot of money
involved. And as a result, they want to sell those before they
go ahead and get their lots of individual shots up to snuff.
And I think it's money, I really believe that.
I think that there is mercury in those vaccines, and during
the time that you say two or three or four or five or six or
seven children are going to possibly die, and we don't want any
child to die, according to my figures, there are 16 children a
day that's going to come down with autism. A day. That's 17,520
children are going to be at risk for autism in the next 3 years
while studies are going on, if mercury has something to do with
it, as many, many people believe.
Scientists, toxicologists, it's not just me. We had a whole
litany of doctors from all over the world talking about this
yesterday. And what you're saying is one thing. But what
scientists and doctors and studies have already shown is that
mercury does have a debilitating impact on the brain. So you're
talking about children at risk. In 3 years that it's going to
take to go through these studies, 17,520 children are likely to
become autistic. If you folks are wrong, how are you going to
live with yourselves?
The gentlelady is recognized.
Ms. Ros-Lehtinen. Thank you so much, Mr. Chairman. I regret
that I have not been able to be here for the entire hearing due
to an overbooked schedule. But I have the testimony and I look
forward to reading it tonight. As I had said before, we have
two good friends of our family, Charles and Patience Flick, who
have two children who are afflicted with autism. I know what a
terrible toll autism can take on a family. Everything that the
Flick family does is related and surrounded by Bonnie and
Willis and their care and what will happen to them. And any
steps the Flick's take, Bonnie and Willis are at the foremost
of their thoughts.
Bonnie is a little more high functioning and was able to go
to Disney World with us. Willis is unfortunately so
overstimulated by the environment that he can barely leave his
house. Everything is too much sight and sound for him. So I
look forward to seeing the fruits of the pressure that Chairman
Burton is bringing to bear on this issue. We need to improve
research dollars, and have more research going into the causes
of autism, to help lead us to a cure. Because I know how
devastating that affliction is, not just on the children who
have it, but on their families.
We look forward to getting more evidence about the
relationship between vaccinations and the rise, dramatic rise
in autism rates. I know that many are not in agreement with
that, but I congratulate Chairman Burton for his steadfast
devotion and his bravery, in spite of all of the attempts of
the scientific and health community trying to make this seem
like there's no tie-in whatsoever. I don't think that we should
leave any stone unturned. If mercury is a factor, we should
give serious consideration to revamping our vaccination program
and looking at other possible factors involved in the dramatic
rates in autism across the country.
So I thank you, Chairman Burton, on behalf of the many
Flick families throughout the United States. Thank you, Dan.
Mr. Burton. I thank the gentlelady.
Mrs. Morella, do you have any comments or questions?
Mrs. Morella. Actually, I commend you for the ongoing
series of hearings that you've had on autism. We all care about
it. I'm really here to listen, to learn and then to do what I
can to lead and I know you have medical experts before you,
many of them who are involved in laboratories in my district,
NIH and of course FDA, and I value CDC.
I'm also interested in the kind of funding that you do
have. Really, we work very hard, just as an example, to double
the funding for NIH for that 5 year plan we had, so that by
2003 we would realize it. We are well on our way, this is our
4th year. I'm curious, with regard to autism, and I must say, a
lot of the leadership on looking into autism obviously has come
from the chairman, although I do wear sometimes my little
jigsaw puzzle ribbon which is autism, the puzzle pieces, right,
which we are trying to put together.
I understand from your testimony, and I guess this would be
Dr. Rennert, that $1 million is being set aside to fund
innovative treatment proposals, and that you have 30
applications. How do you work with that? Are you kind of a
magician?
Dr. Rennert. No, I think one works with it by trying to
fund as many grants as one can, and that the limit is the
number of dollars.
Mrs. Morella. So how many do you think you can?
Dr. Rennert. Well, I think again, the response I would make
is that the amount of funding we could use is equivalent to the
number of meritorious proposals that there are. And it depends
on where you set the bar.
Mrs. Morella. Sounds like a political answer to me.
Dr. Rennert. No, I can't give you a precise number. But the
point is quite clearly, we could use more funding to fund more
proposals and more research on autism.
Mrs. Morella. It just seems to me that of the 30
applications and obviously probably not all would meet the
qualifications, the peer review, what it goes through, but
certainly $1 million isn't going to fund more than a couple of
them, probably.
Dr. Rennert. Three to four is what that would fund.
Mrs. Morella. So it does say something about the need for
us to begin to look more into that in terms of the adequate
funding.
Then I note also, looking at Dr. Boyle's testimony, and I
wasn't here to hear you synopsize it for the committee, but you
mentioned that CDC, NIH and 10 NIH funded centers and programs
of excellence in autism are collaborating on a case control
study of developmental regression. Each of these centers was
awarded funds through the NIH competitive process.
Can you give us like a time line on it, how that is going?
Dr. Boyle. Actually, I may let my colleague at NIH address
that.
Dr. Rennert. Again, the program was initiated in 1997. And
at this point in time, as we mentioned in our testimony, there
are approximately 2,300 patients with well defined autism that
are a part of the network and the study. The second part is
with regard specifically to the question of the temporal
association between vaccination and the onset of autism, as
well as a study of the potential effects of mercurials in
vaccines as preservatives.
There are at the present time 1,600 cases that are being
used for the study. And the phase one part of the study will
look at 250 cases of patients with early onset autism, 250
patients with regressive autism, and a corresponding number of
controls for each group. That work now is in the second phase
where the analysis will begin and the study of the biological
specimens that were obtained.
A third part, because you mentioned it in regard to
funding, I forgot to point out though it was in my written
testimony, that in fact we will release in the coming year an
RFA or request for applications for the competitive renewal and
the commitment to renew these centers for another 5 years.
Clearly, our hope will be that over time, that we could add
more centers to this. But specifically, the element of study
that ought to be completed, as I was asked by Chairman Burton
in the next 2 years or so, is that these studies linking or
attempting to establish whether there's an association or what
the association is between vaccination and thiomercurials will
be completed.
Mrs. Morella. Within 2 years, then, that's what you're
saying, 2 to 3 years. Fine. Thank you, Mr. Chairman.
Mr. Burton. Let me just say to the gentlelady, in 3 years
is what we thought was going to be the study, but if we waited
3 years to have a conclusion drawn, and we continue to use
these kinds of vaccines, we're all for vaccinations, but not
with some of these things like mercury in them, there would be
17,520 new children that would probably be autistic. That is if
mercury did have something to do with it.
I think we're about to wrap this up. We have a number of
questions we'd like to submit to you for the record. I don't
want to keep you here all day. Do we have any parents that have
autistic children in the room? Would you raise your hands?
How many of you believe that your children were adversely
affected by something in the vaccines? Would you raise your
hands? Is that everybody or almost everybody? About 80 percent;
8 out of 12, maybe 9 out of 12. That's what we're getting in e-
mails by the hundreds and thousands.
Now, maybe you folks are right, maybe mercury doesn't have
anything to do with it. Maybe the thimerosal doesn't. But they
think it does. And there's a growing body of these people. And
they're getting organized all across the country, and so is the
Congress of the United States. So I really hope that you'll
take a hard look at this. Because it isn't going to go away.
And as I said before, it's going to cost this country trillions
of dollars.
In any event, do you have any other questions?
Mrs. Morella. No, I don't, but of course I hope on the
basis of all of this that if you can expedite so that we can
come to some conclusions, because I can recognize the passion,
but also the desire for patience that's so difficult for the
chairman. And I would agree with him, if it's been going on
since 1997, we should have some results. Thank you very much.
Mr. Burton. Thank you, Congresswoman Morella.
We will submit these for the record.
There are documents that we'll be requesting. If there's a
problem with you giving those because of confidentiality of any
kind, if you would let us know and we'll be happy to legally
send a subpoena to get that information, because we want to
make sure we have as much research material as possible.
We'd also like to know who are the manufacturers of the
DPAT shot.
Dr. Midthun. I believe Ms. Clay has that.
Mr. Burton. OK. We'll be contacting them to get records on
the supply that they have and how long it will take to go to
single shot vials.
With that, thank you for being here. We stand adjourned.
[Whereupon, at 11:45 a.m., the committee was adjourned, to
reconvene at the call of the Chair.]
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