[House Hearing, 107 Congress]
[From the U.S. Government Publishing Office]
THE STATUS OF RESEARCH INTO VACCINE SAFETY AND AUTISM
=======================================================================
HEARING
before the
COMMITTEE ON
GOVERNMENT REFORM
HOUSE OF REPRESENTATIVES
ONE HUNDRED SEVENTH CONGRESS
SECOND SESSION
__________
JUNE 19, 2002
__________
Serial No. 107-121
__________
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
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___________________________________________________________________________
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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
STEVEN C. LaTOURETTE, Ohio ELIJAH E. CUMMINGS, Maryland
BOB BARR, Georgia DENNIS J. KUCINICH, Ohio
DAN MILLER, Florida ROD R. BLAGOJEVICH, Illinois
DOUG OSE, California DANNY K. DAVIS, Illinois
RON LEWIS, Kentucky JOHN F. TIERNEY, Massachusetts
JO ANN DAVIS, Virginia JIM TURNER, Texas
TODD RUSSELL PLATTS, Pennsylvania THOMAS H. ALLEN, Maine
DAVE WELDON, Florida JANICE D. SCHAKOWSKY, Illinois
CHRIS CANNON, Utah WM. LACY CLAY, Missouri
ADAM H. PUTNAM, Florida DIANE E. WATSON, California
C.L. ``BUTCH'' OTTER, Idaho STEPHEN F. LYNCH, Massachusetts
EDWARD L. SCHROCK, Virginia ------
JOHN J. DUNCAN, Jr., Tennessee 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 June 19, 2002.................................... 1
Statement of:
Bernier, Dr. Roger, Associate Director for Science, Office of
Director, Centers for Disease Control and Prevention,
accompanied by Dr. William Egan, Food and Drug
Administration; Dr. Stephen Foote, National Institutes of
Health; and Dr. Frank DeStefano and Dr. Robert Chen, CDC... 177
Bradstreet, Dr. Jeff, medical director and founder, the
International Child Development Resource Center and an
autism parent; Dr. Andrew Wakefield, research director, the
International Child Development Resource Center; Dr. Vera
Stejskal, associated professor of immunology, University of
Stockholm, founder of Melisa Medica Foundation; Dr. Arthur
Krigsman, pediatric gastrointestinal consultant, Lenox Hill
Hospital and clinical assistant, professor, Department of
Pediatrics, New York University School of Medicine; and Dr.
Walter Spitzer, professor of epidemiology, emeritus, McGill
University................................................. 52
Letters, statements, etc., submitted for the record by:
Bernier, Dr. Roger, Associate Director for Science, Office of
Director, Centers for Disease Control and Prevention,
prepared statement of...................................... 180
Bradstreet, Dr. Jeff, medical director and founder, the
International Child Development Resource Center and an
autism parent, prepared statement of....................... 56
Burton, Hon. Dan, a Representative in Congress from the State
of Indiana:
Exhibit 1................................................ 197
Exhibit 3................................................ 252
Exhibit 5................................................ 280
Exhibit 10............................................... 266
Exhibit 13............................................... 246
Exhibit 14............................................... 293
Exhibit 15............................................... 243
Exhibit 16............................................... 296
Prepared statement of.................................... 6
Krigsman, Dr. Arthur, pediatric gastrointestinal consultant,
Lenox Hill Hospital and clinical assistant, professor,
Department of Pediatrics, New York University School of
Medicine, prepared statement of............................ 131
Kucinich, Hon. Dennis J., a Representative in Congress from
the State of Ohio, prepared statement of................... 403
Morella, Hon. Constance A., a Representative in Congress from
the State of Maryland, prepared statement of............... 398
Spitzer, Dr. Walter, professor of epidemiology, emeritus,
McGill University, prepared statement of................... 139
Stejskal, Dr. Vera, associated professor of immunology,
University of Stockholm, founder of Melisa Medica
Foundation, prepared statement of.......................... 113
Tierney, Hon. John F., a Representative in Congress from the
State of Massachusetts, prepared statement of.............. 49
Towns, Hon. Edolphus, a Representative in Congress from the
State of New York, prepared statement of................... 401
Wakefield, Dr. Andrew, research director, the International
Child Development Resource Center, prepared statement of... 101
Waxman, Hon. Henry A., a Representative in Congress from the
State of California:
Abstract for meeting of Pathological Society............. 153
Prepared statement of.................................... 27
Weldon, Hon. Dave, a Representative in Congress from the
State of Florida:
Article entitled, ``Analysis of Noncoding Regions of
Measles Virus Strains in the Edmonston Vaccine
Lineage''.............................................. 206
Prepared statement of.................................... 45
THE STATUS OF RESEARCH INTO VACCINE SAFETY AND AUTISM
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WEDNESDAY, JUNE 19, 2002
House of Representatives,
Committee on Government Reform,
Washington, DC.
The committee met, pursuant to notice, at 11:10 a.m., in
room 2154, Rayburn House Office Building, Hon. Dan Burton
(chairman of the committee) presiding.
Present: Representatives Burton, Morella, Horn, Davis of
Virginia, Weldon, Duncan, Waxman, Maloney, Norton, Cummings,
Kucinich, Tierney, and Watson.
Staff present: Kevin Binger, staff director; David A. Kass,
deputy chief counsel; Pablo Carrillo Jennifer, Hall, counsels;
S. Elizabeth Clay and John Rowe, professional staff members;
Blain Rethmeier, communications director; Robert A. Briggs,
chief clerk; Robin Butler, office manager; Elizabeth Crane,
deputy communications director; Joshua E. Gillespie, deputy
chief clerk; Michael Layman and Susie Schulte, legislative
assistants; Nicholis Mutton, assistant to chief counsel; Leneal
Scott, computer systems manager; Corinne Zaccagnini, systems
administrator; Lisa Wilson and Katie Yee, interns; Phil
Schiliro, minority staff director; Phil Barnett, minority chief
counsel; Sarah Despres, minority counsel; Josh Sharfstein,
minority professional staff member; Ellen Rayner, minority
chief clerk; and Earley Green, 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 statements be included in the record. Without
objection, so ordered.
I ask unanimous consent that all articles, exhibits and
extraneous or tabular material referred to be included in the
record. Without objection, so ordered.
In April, the committee conducted a hearing reviewing the
epidemic of autism and the Department of Health and Human
Services' response. Ten years ago, autism was thought to affect
1 in 10,000 children in the United States. When the committee
began its oversight investigation in 1999, it was thought to
affect 1 in 500 children. Today, the National Institutes of
Health estimates that autism affects 1 in 250 children. Think
about that. It has gone from 1 in 10,000 to 1 in 250. We have
an absolute epidemic.
In April, we looked at the investment our Government has
made in autism as compared to other epidemics. We showed in
that hearing that the CDC and NIH have not provided adequate
funding to address the issues in a manner that our public
health service agencies have used to address other epidemics.
We have some charts I think are being put on the screen to show
this.
After our hearing, I joined with my colleagues on the
Coalition on Autism Research and Education to request from our
appropriators that at least $120 million be made available in
fiscal year 2003 for autism research across the NIH and an
additional $8 million be added to the CDC's budget for autism
research. Giving more money to research is not the only answer
though. Oversight is needed to make sure research that is
funded will sufficiently answer the questions regarding the
epidemic, how to treat autism and how to prevent the next 10
years from seeing the statistic of 1 in 250 children go to 1 in
25 children.
High quality clinical and laboratory research is needed
now, not 5 or 10 years from now. Independent analysis of
previous epidemiological and case control studies is needed as
well. We have learned that a majority of parents whose children
who have late onset or acquired autism believe it is vaccine-
related. They deserve answers. We have also learned that
parents have been our best investigators in looking for both
causes of autism and for treatment. It has been parents who
have formed nonprofit organizations to raise research dollars
to conduct the research that the CDC, the FDA and NIH have
neglected to do. We have heard from many of these parents in
the past, Elizabeth Birt, Rick Rollens, Shelley Reynolds and
Jeanna Smith to name a few. Each of these parents had healthy
babies who became autistic after vaccination.
I might have been like many of the officials within the
public health community denying a connection had I not
witnessed this tragedy in my own family. I might not have
believed reports from parents like Scott and Laura Bono, Jeff
Sell, Jeff and Shelly Segal and Ginger Brown who came to me
with pictures, videos and medical records. I might have been
like so many pediatricians who discounted the correlation
between vaccination and the onset of fever, crying and
behavioral changes. Because both of my grandchildren, not one
but both of my grandchildren suffered adverse reactions to
vaccines, I could not ignore the parents plea for help and I
could not ignore their evidence. My only grandson became
autistic right before my eyes, shortly after receiving his
federally recommended and State mandated vaccines. Without a
full explanation of what was in the shots being given, my
talkative, playful, outgoing, healthy grandson, Christian, was
subjected to very high levels of mercury through his vaccines.
He also received the MMR vaccine and within a few days, he was
showing signs of autism. I won't go into the details but those
of you who have autistic children know what I am talking about.
As a part of our investigation, the committee has reviewed
ongoing concerns about vaccine safety, vaccine adverse events
tracking and vaccine safety data link, VSD Project, and the
National Vaccine Injury Compensation Program. I have joined
with Congressmen Weldon, Waxman and 32 other Members of
Congress in introducing H.R. 3741, the National Vaccine Injury
Compensation Program Improvement Act of 2002 to realign the
compensation program with congressional intent.
In today's hearing, we will receive a research update from
several previous witnesses as well as new research findings
that further support a connection between autism and vaccine
adverse events. We will learn more about both the possible link
between the use of mercury containing preservative thimerosal
in vaccines in autism as well as autistic entercolitis
resulting from the measles, mumps, rubella vaccine, MMR
vaccine.
Through a congressional mandate to review thimerosal
content in medicines, the FDA learned that childhood vaccines
when given according to the CDC's recommendations exposed over
8,000 children a day in the United States to levels of mercury
that exceed Federal guidelines. Is there a connection between
this toxic exposure to mercury and the autism epidemic? We will
hear from Dr. James Bradstreet and Dr. Vera Stejskal on this
issue.
We have twice received testimony from Dr. Andrew Wakefield
regarding his clinical research into autism entercolitis. We
will learn today that not only has he continued to conduct
clinical research but this research is confirming the presence
of vaccine-related measles, RNA, in the biopsies from autistic
children. Dr. Wakefield, like many scientists who blazes new
trails, has been attacked by his own profession. He has been
forced out of his position at the Royal Free Hospital in
England. He and his colleagues have fought an uphill battle to
continue the research that has been a lone ray of hope for
parents whose children have autistic entercolitis.
Dr. Arthur Krigsman is joining us today as well to discuss
his clinical findings of inflammatory bowel disorder in
autistic children. He will share with us his initial findings
as well as discuss his research plans currently with his
institutional review board for approval.
Do the epidemiological and case control studies which the
CDC has attempted to use to refute Dr. Wakefield's laboratory
results answer the autism vaccine questions honestly?
Epidemiologist Dr. Walter Spitzer is back today to answer this
question. What else is needed to prove or disprove a
connection?
Unfortunately, rather than considering the preliminary
clinical findings of Dr. Wakefield as a newly documented
adverse reaction to a vaccine, the CDC attempted to refute
these clinical findings through an epidemiological review.
While epidemiological research is very important, it cannot be
used to disprove laboratory and clinical findings. Valuable
time was lost in replicating this research in determining
whether the hypothesis was accurate. Officials at HHS have
aggressively denied any possible connection between vaccines
and autism. They have waged an information campaign endorsing
one conclusion on this issue where the science is still out.
This has significantly undermined public confidence in the
career public service professionals who are charged with
balancing the dual roles of assuring the safety of vaccines and
increasing immunization rates.
Increasingly, parents come to us with concerns that the
integrity and honest public health response to a crisis has
been left by the wayside in lieu of protecting the public
health agenda to fully immunize children. Parents are
increasingly concerned the Department may be inherently
conflicted in its multiple roles of promoting immunization,
regulating manufacturers, looking for adverse events and
managing the Vaccine Injury Compensation Program, and
developing new vaccines. Families share my concern that vaccine
manufacturers have too much influence as well. That is
something we continue to look into.
How will HHS restore the public's trust? One of the primary
topics to be discussed at this hearing is access to the vaccine
safety data link. To help fill scientific gaps, the CDC formed
partnerships with eight large health maintenance organizations
through an agreement with the American Association of Health
Plans to continually evaluate vaccine safety. This project is
known as the Vaccine Safety Datalink or VSD and includes
medical records on millions of children and adults.
Until this year, access to data from the VSD has been
limited to researchers affiliated with the CDC and a few of
their hand picked friends. This good old boy network practice
has predictably led to questions about the objectivity of the
research and the fairness of the results. The VSD data should
be made available to all legitimate scientific researchers so
that independent studies can be conducted and the results
verified. This data base contains a wealth of data involving
millions of patients over a 10-year period. If properly
utilized, it can help researchers study vitally important
questions about the safety of vaccines, the effects of mercury-
based preservatives and childhood vaccines and many other
questions.
The committee first raised this issue with the CDC 2 years
ago. For 2 years the CDC delayed. Six months ago, we were
informed the CDC was developing a plan to expand access to the
data base. Finally, in February of this year after a great deal
of prompting from the committee, Dr. Robert Chen, Chief of
Vaccine Safety and Development at the National Immunization
Program, informed our committee staff that the CDC had
finalized its plan and that it was poised to put it into
effect. Under this plan any legitimate scientist could submit a
proposal to the CDC to conduct research using VSD data and
access to the data would be provided along with some scientific
or basic safeguards.
In preparation for today's hearing, committee staff asked
the CDC why the plan describe to us in February had not been
put into effect. The staff was informed that it had been put
into effect. However, there has been no public announcement.
They put it into effect but didn't tell anybody. How are
researchers supposed to know about availability of the data if
there is no announcement? It took 2 years of prodding by this
committee to get the CDC to open up access to the data base.
For 4 months, it appears the CDC didn't inform anybody but this
committee of the data's availability. That doesn't make it
appear that the CDC is making a good faith effort to open up
this data base. It looks to me like the CDC is trying to do the
bare minimum they have to do to get us off their backs, and
that is not acceptable.
That is why I insisted that Dr. Chen be here today. I just
wanted to ask him why they didn't tell anybody about the data
base being available. I would like to know how he expects
researchers to use this data if nobody tells them it is
available. Dr. Roger Bernier is here from the CDC to testify
about these issues. He is accompanied by both Dr. Chen, the
creator of the VSD Project, and Dr. Frank DeStefano, the CDC
official who is also co-author of the MMR IVD study. They are
here to address our questions on the VSD Project and the
vaccine autism research. The CDC employees are accompanied by
Dr. Stefan Foot and the National Institutes of Health from the
National Institutes of Health and Dr. William Egan of the FDA.
As representatives of the people, we have a responsibility
to ensure that our public health officials are adequately and
honestly addressing this epidemic and its possible links to
vaccine injury.
I look forward to hearing from our witnesses and the
hearing record will remain open until July 3.
[The prepared statement of Hon. Dan Burton follows:]
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Mr. Burton. I now recognize Mr. Waxman.
Mr. Waxman. Mr. Chairman, today you have convened a hearing
about the safety of vaccines. This is an important topic and
also a familiar one to this committee. Over the last several
years, you have held a series of hearings raising questions
about the safety of vaccines, questions that undoubtedly have
caused real concern among some parents and clinicians. These
hearings have had some positive effects. Your interest over the
years has led to unprecedented attention to vaccine safety.
Since your first hearing on the topic, many respected
researchers have chosen to investigate whether vaccines are
associated with inflammatory bowel disease, autism, diabetes
and other assorted conditions among children.
While rare side effects from vaccines are always possible,
these studies have not found that vaccines are associated with
any of these serious health problems. Since your first vaccine
safety hearing, a blue ribbon panel of scientists convened by
the Institute of Medicine has reviewed many of the most widely
disseminated theories alleging harm from vaccines. This
esteemed panel evaluated the allegation that the MMR vaccine
causes autism. It studied the claim that thimerosal, a vaccine
preservative, caused developmental delay. It reviewed whether
the Hepatitis B vaccine causes neurological injury. It assessed
the theory that multiple vaccinations cause allergies and
asthma. In each case, the Institute of Medicine panel has found
that scientific evidence does not validate the theories. Expert
panels in other nations have reached similar conclusions.
Mr. Chairman, you have challenged the public health system
to defend itself against numerous allegations that vaccines
cause a wide variety of problems. I am not aware of any
allegations about the safety of vaccines that you have not
pursued. So far, the subsequent investigations and expert
reviews have found vaccines to be safe. Because of your efforts
in this area, Americans can have more confidence today in the
safety of the vaccine supply than ever before.
There has also been a negative consequence to your
approach. You have repeatedly provided a forum for
unsubstantiated allegations about vaccine safety that have
alarmed and confused parents. Although the scientific evidence
for vaccine safety has grown stronger, parental concerns about
vaccine safety have also increased since you started these
hearings. This is a potentially dangerous development because
it can lead to lower immunization rates and more disease.
I recently asked the Centers for Disease Control to
describe what would happen if MMR immunization rates dropped.
According to CDC, if immunization rates dropped to the levels
they were in 1989, we could see over 26,000 hospitalizations
for measles, 8,500 cases of pneumonia, 135 cases of
encephalitis, and 224 deaths. According to the CDC, even a drop
in immunization rates of 10 percent could result in an
additional 2 million kids being susceptible to measles. It
would also significantly increase susceptibility to rubella and
congenital rubella syndrome which can cause serious birth
defects such as blindness, deafness, and stillbirths.
Congenital rubella syndrome is also a well known cause of
autism, a disease we all want to prevent. How tragic it would
be if an unjustified vaccine scare caused some children to die,
others to have permanent brain deficits, and still others to
suffer from autism. I ask that the information from the CDC be
placed in the record at the conclusion of my statement.
While I am strongly opposed to reckless allegations about
vaccine risks that scare parents and are not supported by the
science, I also recognize that questions about vaccines will
always arise. That is why I support efforts to fund additional
research on vaccine safety. Some of the theories on the agenda
for today do require additional research and I am pleased the
Government is supporting such studies.
I also want to ensure that the Government does not lose the
ability to conduct valid vaccine safety studies. We must assure
the future of initiatives like the Vaccine Safety Datalink
Project. This is a unique collaboration between CDC and several
large health maintenance organizations that allows for valid
and timely research on vaccine safety. Indeed this research has
led to many important policy changes over the years.
Today, we will hear from scientists at CDC who work closely
with the Vaccine Safety Datalink Project. These scientists are
quite concerned about your threats to subpoena the raw data
from this data base to pursue a vaccine related allegation
because the raw data contain identifiable information from the
medical records of more than 6 million Americans. A
congressional subpoena would constitute a serious violation of
medical privacy. According to CDC, a subpoena could have the
effect of driving health maintenance organizations from the
program and destroying CDC's ability to scientifically test
hypotheses relating to adverse effects potentially associated
with vaccines. In other words, we are going to end up causing
more harm than doing good if we pursue this subpoena approach.
You have an alternative to a subpoena, Mr. Chairman. The
CDC has worked with HMOs to create a process for allowing
independent researchers access to this data. I continue to urge
you to accept this solution and renounce your subpoena threat.
Finally, I would like to address some allegations that Dr.
Wakefield makes in his written testimony. Dr. Wakefield implies
that a witness who testified here last year, Dr. Michael
Gershon, either perjured himself or was guilty of sloppy
science by noting problems in the lab that Dr. Wakefield used
in his research. Dr. Gershon did not lie to this committee and
this portion of his testimony did not involve his scientific
expertise and thus was not sloppy. Dr. Gershon related what he
was told by Dr. Michael Oldstone of the Scripps Institute, who
has performed an evaluation of this lab. Dr. Gershon continues
to stand by his testimony.
Dr. Wakefield also is planning to make a needless attack on
Dr. Gershon's wife, who he alleges may have a financial
interest in the chicken pox vaccine. In fact, according to Dr.
Gershon, while his wife did conduct research relevant to a
chicken pox vaccine patent, neither he nor his wife has any
financial interest in the vaccine or its manufacturers. Dr.
Wakefield's allegation is therefore groundless as well as
gratuitous. Dr. Gershon's testimony last year was quite lengthy
and he raised many scientific issues but Dr. Wakefield has not
refuted any of them. Instead, he is resorting to name calling
which does not move these scientific issues along and is
unproductive.
I am going to ask unanimous consent that the written
testimony of Dr. Elizabeth Miller of the Public Health
Laboratory Service of the United Kingdom be entered into the
record and I also alluded to other information which I would
also like attached to this opening statement and made a part of
the record.
I thank the witnesses for coming today. I look forward to
your testimony and I yield my time.
[The prepared statement of Hon. Henry A. Waxman follows:]
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Mr. Burton. Regarding the unanimous consent, we would like
to review it. We probably have no objection and would like our
staff to take a look at that information. So we reserve
notation on that. Do we have a copy of that?
Mr. Waxman. We will make everything available to you and
your staff to put into the record. I would note that the
chairman asked for unanimous consent at the beginning of this
hearing for all submissions of materials to be part of the
record. I would hope you would come to the same conclusion with
regard to these.
Mr. Burton. We probably will. We just want to review it
real quickly.
Mr. Waxman. I have no problem with that.
Mr. Burton. Mr. Weldon.
Mr. Weldon. Thank you, Chairman Burton, for calling this
hearing.
As a physician who continues to see patients, I have a
very, very strong interest in maintaining the safety and
integrity of our national immunization program. The response
from the CDC and the NIH to the growing concerns over the
safety of the measles, mumps, rubella or MMR vaccine continues
to baffle me. While this vaccine may be safe for most children,
there is growing clinical evidence that a subset of children
may be suffering very severe reactions to the MMR.
For too long, public health officials and those with a
vested interest in the status quo have engaged in what I
perceive to be denial or simply view those who suffer severe
adverse reactions as the cost of doing business. We have a
moral imperative to look at the clinical evidence to determine
why some children may be suffering reactions to MMR. For nearly
3 years, I have been urging the CDC and NIH to more
aggressively move to address these concerns and I must say I
have been disappointed by the failure of the CDC and NIH since
these concerns were first raised in a study published in 1998,
and they have not addressed this issue. The CDC in conjunction
with public health officials in the United Kingdom have
responded to each new clinical study raising safety concerns
about the MMR with an epidemiologic study, a statistical study.
They did this after the 1998 Wakefield Study, they did it with
the study issued in January of this year by Oman et al and they
did it again last week in anticipation of the release of a
study identifying vaccine strain measles as the strain in the
affected children in the Oman study.
These statistical studies have been released with great
fanfare to the media and the media thus far have given the
expected response of proclaiming the complete safety of the MMR
vaccine. Those who have been raising these questions and
conducting clinical research in this area have grown to expect
the mantra, our statistics say that this cannot be.
I must say, if their purpose is to preserve the status quo
and succeed in a public relations campaign, they have been
successful, at least to date. However, if their purpose is to
directly address the clinical findings of persistent measles
infection in seriously affected children, their efforts have
been a dismal failure. They have not produced one clinical
study to directly address these concerns.
My message to the NIH, particularly to the CDC, is put away
your statistics textbooks and get out your microscopes. Failure
to do so only breeds speculation and undermines public
confidence and ultimately makes the job of clinicians more
difficult.
Thank you and I yield back.
[The prepared statement of Hon. Dave Weldon follows:]
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Mr. Horn [assuming Chair]. Ms. Watson.
Ms. Watson. Thank you for this opportunity to address some
issues that have been of great concern to me for a while.
As you know, I am co-sponsoring, with Congressman Burton, a
bill that would require informed consent on the part of
patients at a dentist's office when the dentist is getting
ready to put in a filling that is an amalgam that contains
mercury because over the years there has been a connection
between mercury and amalgam and an effect on not only brain
cells of the mother but going through the placenta into the
fetus.
I will listen very intently in the time that I have to hear
from CDC and the other witnesses about the connection of
vaccines and autism because we are thinking now that any kind
of foreign substance that is toxic that you put into any
orifice of the body has an effect and certainly mercury in the
teeth.
I have had dentists come to me and argue against our
proposition from the standpoint of questioning the research.
This morning I put on a ring and I can taste silver on my
tongue. This is nickel and there is an effect that metals do
have in the body from things that we apply to it and ingest,
that are put into these orifices.
I am hoping that CDC will support the work of Dr.
Wakefield, make the connection, report back to us. Then I will
start looking into the use of nickel and nickel is in most
custom jewelry, in the ear rings that we wear, the ring that I
have on and so on. It does have an effect on the body.
I want to thank the chairman for having this hearing. There
have been hearings before and I am sure there will be hearings
and I am listening very closely to see if we can indeed draw
that linkage from vaccines to autism and other conditions that
face not only children but human beings as a whole.
Thank you, Mr. Chairman.
Forgive me for running out to my next hearing before I can
hear all the witnesses.
Mr. Horn. Thank you very much.
The gentleman from Tennessee, Mr. Duncan.
Mr. Duncan. Thank you, Mr. Chairman.
I don't have a formal opening statement but I do want to
say I want to thank Chairman Burton for calling this hearing
and continuing to pay close attention to what I think is a
very, very important topic. I mentioned at the last hearing
that I became interested in this because I talked to several
parents who told me very sad, heartbreaking stories about
healthy children they had and just terrible problems that
occurred after taking some of these vaccines. I think this is
something we really need to look at.
I have been sitting reading the testimony of the witnesses
and looking through these outstanding notebooks that the staff
has prepared for us. I think this is something that we need to
have a hearing about and we need to continue to research and
look into this as fully as we possibly can.
I thank you for calling this hearing.
Mr. Burton [presiding]. Mr. Cummings.
Mr. Cummings. Thank you, Mr. Chairman.
I want to thank you for holding this hearing and I want to
thank you for your tremendous interest in health care and for
the recent hearing that you held with regard to disparities in
health care.
Our committee has held several hearings exploring vaccine
safety and the theories on the correlations between
vaccinations and autism. Let me say first off that vaccinations
have played a very significant role in this country and across
the world. When we think of diseases like polio and smallpox
and many others, vaccines have certainly allowed many to live
who probably would have died and helped them to live the best
lives they could as opposed to suffering.
Additionally, the committee initiated investigation into
the dramatic rise in autism rates across the country. Autism is
a disorder that severely impairs development of a person's
ability to communicate, to interact with others and to maintain
normal contact with the outside world. One of the most common
developmental disabilities, autism affects 2 to 5 out of every
10,000 children and usually appears before the age of 3.
The causes of autism are unknown. There are some effective
treatments for some children but there is no cure. In the past,
autism was considered a rare disorder. However, today, autism
is being diagnosed much more frequently. There have been
approximately 2,800 cases of autism reported in my State of
Maryland. Additionally, there has been a rise in the number of
autism cases in California, New Jersey and other States.
Although at this time, it is unclear whether the rise in the
number of autism cases is due to increased reporting or demand
for services, emerging data appears to support the theory that
changes in diagnosis explain the rise in autism cases. Parents
everywhere are anxious to learn more about the possible links
between common preservatives in childhood vaccinations and
developmental problems whose symptoms resemble those of autism.
Symptoms of mercury toxicity in young children are extremely
similar to those of autism.
There is a growing awareness of the nature of autism and
the kinds of approaches to diagnosis, treatment and care that
are likely to be effective in meeting the needs of autistic
individuals and their families. Diagnosing autism today
requires specific training and experience. I would encourage
medical schools to offer specialized training for our nursing
and medical students for autism.
As I said in past hearings, I applaud the Centers for
Disease Control and Prevention, the National Institutes of
Health, as well as the Kennedy Kreiger Institute, the Center
for Development and Behavioral Learning at the University of
Maryland School of Medicine in Baltimore and the many other
organizations for their continued research on autism.
Congress should allocate more money for autism research. I
offer my support to the families of autistic children. We must
continue to look for the cause and cure of autism. I am
convinced that with further research a cause and cure will be
found. As such, I strongly believe that all theories for the
cause of autism must be objectively researched. I look forward
to hearing from today's witnesses and learning more about the
Vaccine Safety Datalink, a large, linked data base that the CDC
uses to research vaccine safety.
Again, I thank you for the hearing and with that, I yield
back.
Mr. Burton. Thank you.
Mr. Horn.
Mr. Horn. I commend you, Mr. Chairman. I have sat through
these hearings and we have really looked at this situation. I
look forward later in the day, I have to go to Transportation
and Infrastructure right now but thank you for putting all this
together with the staff.
Mr. Burton. Mr. Tierney.
Mr. Tierney. Thank you for having these hearings.
I would like to get to our witnesses. I am pleased we are
going to have testifying today individuals and representatives
from the CDC and others who are actually conducting the
research into autism's causes. I really believe that affected
children and their families obviously can't afford to have us
be complacent about this disorder.
I would like to enter my complete remarks in the record and
look forward to hearing from the witnesses today.
[The prepared statement of Hon. John F. Tierney follows:]
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Mr. Burton. Thank you.
We would like to have Dr. Bradstreet, Dr. Wakefield, Dr.
Stejskal, Dr. Krigsman and Dr. Spitzer come to the table. Let
me just say that the purpose of the Government Reform
Committee, it is not called oversight anymore but that is still
our responsibility, to conduct oversight into every agency of
Government where we think there is a problem. The minute the
Congress of the United States stops asking questions about very
important issues like vaccine safety which affects every single
person in this country, then we will be guilty of dereliction
of our responsibilities. As long as I am chairman of this
committee, I am going to continue to ask these questions.
I want to make one more brief comment and that is we have
gone from 1 in 10,000 children who are autistic to 1 in 250.
Somebody has to begin explaining why this horrible tragedy is
occurring, why we have this epidemic. We are not getting the
answers. We have an epidemic here and we can't just close our
eyes and stick our heads in the sand. We have to find out why
this is going on. The health agencies have not yet given us an
adequate answer.
I would now ask the witnesses to rise so that I can swear
you in.
[Witnesses sworn.]
Mr. Burton. Dr. Bradstreet, do you have an opening
statement?
STATEMENTS OF DR. JEFF BRADSTREET, MEDICAL DIRECTOR AND
FOUNDER, THE INTERNATIONAL CHILD DEVELOPMENT RESOURCE CENTER
AND AN AUTISM PARENT; DR. ANDREW WAKEFIELD, RESEARCH DIRECTOR,
THE INTERNATIONAL CHILD DEVELOPMENT RESOURCE CENTER; DR. VERA
STEJSKAL, ASSOCIATED PROFESSOR OF IMMUNOLOGY, UNIVERSITY OF
STOCKHOLM, FOUNDER OF MELISA MEDICA FOUNDATION; DR. ARTHUR
KRIGSMAN, PEDIATRIC GASTROINTESTINAL CONSULTANT, LENOX HILL
HOSPITAL AND CLINICAL ASSISTANT, PROFESSOR, DEPARTMENT OF
PEDIATRICS, NEW YORK UNIVERSITY SCHOOL OF MEDICINE; AND DR.
WALTER SPITZER, PROFESSOR OF EPIDEMIOLOGY, EMERITUS, MCGILL
UNIVERSITY
Dr. Bradstreet. Unfortunately, the nature of autism is so
complex that to do it in 5 minutes will be challenging, so I
have submitted, under Tab 5 a more complete review of the
nature of our research. I will try to get through my slides
quickly.
Thank you very much for the hearing and for an opportunity
to present this. Dr. Weldon and I previously met 2 weeks ago in
your office with the Deputy Secretary of Health and Human
Services, Claude Allen, to present this data to him. So he has
been made aware of it. It was a very encouraging and positive
meeting and I look forward to the outcome of that over time.
The prevalence may be both misunderstood and
underestimated. Two recent studies, one from England and a CDC
study with Brick Township indicated between 57 per 10,000 and
67 per 10,000 children. However, autism is primarily a boy
related disorder, four to eight times as many boys suffer with
this disorder. That means the prevalence is therefore in the
order of 1 percent for boys.
The economic impact: We estimate that there are
approximately 420,000 children with autism in this country at
this time based on those studies, greatly less than what the
Time Magazine article said at 1 million. However, that puts a
price tag over the next 50 years to take care of these children
in excess of $1 trillion. The lifetime costs could be $3 to $4
trillion for the families and for society with the lost wages
and other factors.
The biological evidence for causality is growing
significantly and for those members of the committee who may
not be familiar with me, I am a physician, I am also a parent
of a child with autism and I am a clinical researcher
associated with studies currently ongoing at 14 medical schools
around the world.
The growing evidence is substantial that measles virus is
still the frontrunner with the viral etiology aspects of things
and not all children suffer from measles virus related
disorders, but we will show you today some examples that are
quite impacting.
Additionally, auto-immunity continues to be published by a
variety of researchers at multiple medical schools that there
is a unique disorder affecting the immunity in these children
where they become immune to their gut and their brain, and that
is a disaster for them.
Mercury and to a lesser extent lead remain significant
toxin burdens, and we presented that data to the Institute of
Medicine in July of last year.
I am going to present two cases today and I will try and go
through them briefly. Matthew who was born in 1984 from an
uncomplicated pregnancy and an easy delivery had a normal early
development except he did develop some gait abnormalities that
are very consistent with what you might expect from mercury. We
will see that data later on. He had a rapid decline after each
of two MMRs. He did receive those in combination with other
vaccines, however. He developed auto-immunity to myelin basic
protein, a critical insulator of the brain. He suffered
seizures shortly after the second MMR and he has persistent
immune deficiency with protracted low lymphocyte counts.
He has inflammatory bowel disease that has been documented
on endoscopy and biopsy. He has persistent measles virus genome
in that inflammatory bowel disease. He has persistent measles
virus in circulating white blood cells. He has persistent
measles virus F gene in his cerebral spinal fluid, which is the
fluid that surrounds the brain, implying it is present in the
brain as well. He has autoantibodies to measles virus in his
spinal fluid. He has autoantibodies to myelin basic protein in
his spinal fluid, a very low serum sulfur level, and cysteine
level and very high mercury as a result of that.
That is my son--Matthew--who is also the inspiration for
our research and the work that we do. He was a very happy, well
connected child prior to his MMR at approximately 12 months of
age and that is Matthew completely lost about 2 months after
his MMR vaccine.
This is a copy of the laboratory results documenting the
presence of measles virus in his terminal ileum. This is a copy
of the laboratory results from Utah State University where
Matthew had his spinal fluid analyzed which showed antibodies
to myelin basic protein and to measles virus in his spinal
fluid.
This shows the presence of antibodies in his RBCs, the
presence of virus in his red blood cells and also presence in
his cerebral spinal fluid.
This is his first mercury titer showing marked elevations
of mercury, and you can see for all those essentially the only
thing that is truly abnormal is the significant increase in
mercury.
The first challenge test to get mercury out of his body
resulted in an extremely high titer. That number of dots
actually represents 24 mcg per gram. It would take it well off
the slide, perhaps into the next room.
This is an interesting correlation. Mark Blaxil presented
this to the Institute of Medicine last year and that shows that
rising titer of cumulative mercury in the vaccine program in
California compared to the prevalence of autism in California.
I want to superimpose on that a very interesting graphic
derived from the government Web site on the use of
methylphenidate, also known as ritalin or concerta. Look at the
time relationship. It is identical. In 1990, the rise in the
mercury titer started to go up and in 1990 there is a striking
and continuous rise in the use of ritalin in this country which
I think is rather telling.
This is the thimerosal versus autism relative risk that was
produced in the CDC confidential study which was acquired under
the Freedom of Information Act showing that at the time
approximately 62 mcg of mercury is administered, there is more
than a doubling of the relative risk of autism.
This is a copy of a transcript from the Simpsonwood
meetings, page 229 where Dr. Brent, who is not employed by the
CDC, but who is a public health official from one of the
States, said ``The medical legal findings in the study, causal
or not, are horrendous. If an allegation was made that a
child's behavioral findings were caused by thimerosal
containing vaccines, you will not find a scientist with any
integrity who would say the reverse with the data that is
available. So we are in a bad position from the standpoint of
defending the lawsuits if they were initiated and I am
concerned.'' I think that may set part of the tone for what we
have seen happen in the last several years.
Additionally, there was a very good documentary on this.
Parents are aware and I think it is very important for Congress
to be aware that the parents are receiving information from a
variety of outlets. This is not your doing or undoing of
policy. Parents are well educated, they are hungry for
information and they currently don't believe many of the
reassurances that are being provided by CDC.
Case two is very similar to my son and I present it so that
you will realize that my son was not an isolated case. He had
normal developmental milestones. He developmentally arrested
shortly after his first MMR at 15 months. He again has
antibodies to many things in his brain and persistent measles
virus in places that it doesn't belong including his cerebral
spinal fluid.
This lab slide indicates he has antibodies to myelin basic
protein and to measles in his spinal fluid. He has this unique
antibody, this is the presence of MMR antibody which is
actually the H protein or the hemogluten protein from the
measles virus of a special antibody titer that was derived
using the MMR vaccine, done in Dr. Singh's laboratory at Utah
State University, also positive in spinal fluid.
We presented this data, Dr. Singh and myself, at the
American Society of Microbiology last month which indicates
that 50 percent of children in our study had antibodies to this
special measles, mumps, rubella derived protein in their
cerebral spinal fluid and also 86 percent have antibodies to
myelin basic protein in their spinal fluid, and again a very
high percentage, up to 100 percent, had antibodies to myelin
basic protein in their blood. This is not present in normal
controls. This is a controlled study. We now have significant
controls and we do not see these present. This is not an
antibody leakage, this is real disease in these children.
Scott has documented measles virus in his terminal ileum
and his blood as well as his spinal fluid. These are the
laboratory data.
I want to include from Dr. Menkes, his comments, where he
concludes that this is related to the MMR vaccine in this
particular child. Dr. Menkes wrote the textbook ``Child
Neurology.'' He is considered to be one of the foremost experts
both on child neurology and on vaccine safety and has concluded
that measles, mumps, rubella vaccine is causing this syndrome.
I think it is always important to put a face with this.
This is impacting human lives.
I would leave you with some questions. I think there are
some important things that we need to ask. These are in the
handout but as we work through this, I think we need to ask:
what if Dr. Wakefield, myself, Dr. Singh, Dr. O'Leary and Dr.
Menkes and others are right, what then? What would be the
reaction of public health officials if in fact this data, as we
believe, is verifiable? In addition, what is the response to
treating these kids? How are we going to get this virus out of
these kids and restore them to good health? Have we traded a
very rare occurrence of severe side effects to natural measles
infection for a very common occurrence of autism?
With that, I will end because I think I have gone past my
time.
[The prepared statement of Dr. Bradstreet follows:]
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Mr. Burton. That is all right. I think it was very
informative.
Dr. Wakefield.
Dr. Wakefield. It is a great pleasure to be back here
again.
Before bringing you up to date with the research linking
MMR vaccine to autism, I would like to put the record straight
with respect to Dr. Gershon's testimony last year on the
molecular detection of measles virus in the laboratory of
Professor O'Leary. Dr. Gershon's was false in relation to a
number of assertions, whether or not his testimony constituted
perjury or simply sloppy science. It is not my wish to take up
valuable time in this hearing with the details of Dr. Gershon's
unacceptable errors or correspondence relating to this. All raw
data have been provided to both the ranking majority and
minority members.
Merely by way of illustration, he stated that tissues from
experimental animals and others infected with measles virus
were positive in Professor O'Leary's lab. In fact, they were
all entirely and consistently negative on repeat testing in
blinded studies.
Scientifically, Dr. Gershon's behavior was a disgrace and I
stand by that. I would level the same charge at anyone who
relies on or has relied on in any way upon his testimony. The
disgrace is that he did not check the raw data before impugning
the reputation of a fellow scientist before the eyes of the
world. I am not surprised that Dr. Gershon has turned down on
two occasions the offer to appear before this committee.
Let me turn now to the current state of the science. The
association between MMR vaccine autism and intestinal
inflammation was first suggested by my group on the inspiration
of parents from the Royal Free Hospital Medical School in 1998
in a paper published in the Lancet. This is well known to you.
The same research team in collaboration with Professor John
O'Leary and Dr. Simon Murch, a pediatric gastroenterologist
from the Royal Free Hospital have since shown in a
comprehensive series of what were 8 and now 10 peer reviewed
scientific studies that the major findings of our original
study were indeed correct. These papers are listed in the
appendix. The papers are here and I will make them available to
anyone who wishes to read them.
The sum of the research of my group and our collaborators
taken together with additional work by independent physicians
and scientists in the United States has now confirmed the
following facts. Children with regressive autism and intestinal
symptoms have a novel and characteristic inflammatory bowel
disease. This disease is not found in developmentally normal
control children. This disease is entirely consistent with a
viral cause. This disease may be the source of a toxic or
immune insult to the brain. The measles virus has been
identified in the diseased intestine in the majority of
children with regressive autism studied, precisely where it
would be expected if it were the cause of the intestinal
disease.
These children who suffer the same pattern of regressive
autism and intestinal inflammation come from many countries,
including the United States and Ireland where they have been
investigated and biopsied independently. These biopsies have
been no where near my laboratory.
Measles virus has been found in only a small minority of
developmentally normal control children. The measles virus in
the diseased intestine of autistic children is from the
vaccine. Children with regressive autism appear to have an
abnormal immunal response to measles virus, as you have heard
from Dr. Bradstreet, and these findings are entirely consistent
with parental reports that their normally developing child
regressed into autism following exposure to the MMR vaccine. As
you will hear from my colleague on my left, Dr. Stejskal, these
findings are also entirely consistent with an immune mediated
damage to the developing child by thimerosal.
Confirmation of the intestinal findings, other researchers
in the United States have confirmed the presence of intestinal
inflammation in children with regressive autism and we will
hear testimony from Dr. Krigsman to this effect independently,
the link between measles virus and children who were given the
MMR vaccine and abnormal immune responses.
Measles virus sequencing has been performed, most
significantly a study due to be presented at the Pathological
Society of Great Britain and Ireland in Dublin at the beginning
of July has confirmed that the measles vaccine virus is present
in the diseased intestinal tissues of these children. The
Dublin researchers, headed by Dr. John O'Leary, professor of
pathology at Trinity College, Dublin, examined viral genetic
material from intestinal biopsies taken from 12 children with
gastrointestinal disease and autistic spectrum disorder.
The viral genetic material had already been identified as
coming from measles virus in a study published in January in
Molecular Pathology. Using state-of-the-art molecular science,
the samples from these 12 children have now been characterized
as from the vaccine strain virus. This investigation continues.
These data constitute a key piece of evidence in the
examination of the relationship between MMR vaccine and
regressive autism.
We heard last year about rechallenge phenomena, children
who had received more than one dose of the vaccine. A further
key piece of evidence comes from the examination of these
rechallenge cases and biological gradient effects. I will
explain what I mean by that.
Rechallenge refers to a situation where exposure of an
individual to an agent, for example a vaccine elicits a similar
adverse reaction to vaccine following the initial exposure. The
secondary reaction associated with rechallenge may either
reproduce the feature associated with the primary challenge or
lead to worsening of the condition that was initially induced.
In other words, Mr. Chairman, I give you a drug, you develop a
rash. That could be coincidence. I give you the same drug
again, you develop the same rash, that is not coincidence until
proven otherwise.
During the course of our clinical investigations, we have
observed some children who received a second dose of MMR or in
the UK, boosting with the combined measles rubella vaccine
experience further deterioration in their physical and/or
behavioral symptoms as explained in Dr. Bradstreet's trial.
In a report of April 2001, the Vaccine Safety Committee of
the Institute of Medicine said that in the context of MMR
vaccine as a possible cause of this syndrome, challenge,
rechallenge would constitute strong evidence of an association.
In the context of adverse reactions, a biological gradient
refers to an increasing severity of the disease upon repeated
exposure.
We have undertaken a systematic evaluation of rechallenge
and biological gradient effects in children with regressive
autism who have undergone investigation at the Royal Free
Hospital. We have compared exposed children, those who have
received more than one dose with those who have only received
one dose to ask is there a sequential deterioration in their
behavior and development compared with the group who only
received one dose and is there worsening of the intestine or
inflammation.
In analysis based upon the exposed and unexposed children,
we find that secondary regression on the basis of three
independent analyses including parental history alone,
excluding those children whose secondary deterioration appeared
after the publication of our first paper in 1998, or inclusion
of only those children for whom we can find independent
corroborative evidence in their records there is a highly
significant effect in terms of secondary deterioration in the
children who had two doses compared to those who only had one.
Secondary physical symptoms, for example, deterioration in
their bowel disease, their bowel symptoms is present. Severe
lymphoid hyperplasia, you will remember the swelling of the
lymph glands in the intestine is significantly worse in the
children who have had two doses, and to me as a pathologist,
the most significant finding is the intestinal inflammation, a
blinded observation made independently of any knowledge of the
child's deterioration or their vaccination status shows that it
is much worse, worse in those children who have received two
doses than one.
This is something you cannot confabulate. The quality of
records might not be good enough to make didactic decisions
about deterioration but you cannot fake the state of a child's
intestine in terms of inflammation.
These data identify rechallenge effects upon symptoms and
the biological gradient effect upon severity of intestinal
inflammation but provide evidence of a causal association
between MMR and regressive autism.
What about the political aspects of this? I have repeatedly
requested a meeting with the Sir Liam Donaldson, the UK's Chief
Medical Officer, in order to discuss this situation. His
response has been to refuse to meet but instead to demand that
we send him the children's samples. He has provided absolutely
no indication in terms of scientific protocol how he would
proceed to analyze these samples. He may have a PCR machine in
his kitchen for all I know. I do not know how he intends to
analyze them.
He has, as far as I am aware, no ethical approval for
analyzing these samples but he may be reassured to know that
independent testing is being conducted and that as part of the
litigation process in the UK, the defendants are being provided
with identical samples for entirely independent analysis.
The last 7 days have seen a report in the journal Clinical
Evidence from the UK publicized as new research, disproving any
links between autism and the MMR vaccines. The author
specifically excluded clinical research into the bowel disease,
in other words, everything that has been performed in my
laboratory.
They do not cite any of our publications beyond the initial
study of 12 children in 1998. In fact, this paper does no more
than review the epidemiological studies that have already been
deemed irrelevant by the members of the IOM committee.
In closing, Mr. Chairman, Dr. Bradstreet's data somewhat
underestimate the size of the problem. A recent study published
by the National Autistic Society in the UK shows that in
primary school children, those between 4 and 11, autism now
affects 1 in 86 children, not 1 in 86 boys but 1 in 86
children. This is a staggering level of a disease. It is
unacceptable and no society can afford to sustain this
attrition of its children. Something has to be done. We have to
depoliticize this process and conduct the science that is
necessary to answer the questions. Thank you.
[The prepared statement of Mr. Wakefield follows:]
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Mr. Burton. Before we go to the next witness, I believe
other scientists who have differed with the prevailing opinions
have suffered similar castigation as you have. You may rest
assured that eventually the truth will out. Louis Pasteur found
that out after 17 years when he was knighted, so eventually the
truth will come out and those who criticize and continue to
denigrate what you have done will be eating a heck of a lot of
humble pie.
Dr. Stejskal.
Dr. Stejskal. I am honored to be here and this is my first
testimony. In this limited time, I am going to tell you why I
am here and what are my credentials.
I have been working for 20 years in pharmaceutical industry
directing a group of clinical immunotoxicologists so I have
been working with allergy to simple chemicals like mercury for
20 years.
What I am going to tell you is the fact which has not been
mentioned here before, to my big surprise, and this is that
thimerosal in clinical setting is a strong allergen. You can
learn about it more by looking on our Web site which I will
show later where I compiled the studies from all over the world
telling us that thimerosal obviously due to vaccination is No.
1 childhood allergen, meaning that if you are getting a special
testing, which I will tell, 10, 20, 30 percent of the children
are allergic.
I will tell you why this is risky to be allergic if you
don't know this and I will also tell you how it goes together,
opening ways to autoimmunity and at the end to be constructive.
I will tell you how to diagnose the causes which are leading to
autism and what studies should be conducted.
I been also asked to see if it is plausible that there is a
synergistic reaction between thimerosal and MMR and yes, it is
and I will tell you why.
You are well acquainted with the fact that mercury, not
organic mercury only but also inorganic mercury, will damage
the brain, especially organic mercury because it is lyophilic,
it will easily go to the brain. There are some ways we call
retrograde transport. If someone wants, it is on our Web site.
So in addition to toxicity, which is very important which can
damage, you also have to worry about allergy.
Allergy is a thing which explains to us why not every child
is affected by vaccination. This is something which is very
important. As you know, some children cannot eat eggs, some
others cannot ride a horse because they are allergic to horses,
and some don't eat fish, people don't either, which is also
very important. Allergy affects the brain. As you know, in
spring when there is pollen around, people become sleepy, they
cannot concentrate. This is due to the chronic inflammation
which is affecting the brain. This may be part of the answer
why Dr. Wakefield sees inflammation in the stomach affecting
the brain. This is another reason why we can see that in
certain children, especially the autistic ones, also other
types of allergies like food allergy, increased denigration of
the immune system.
This is very simply showing you that we are not equal.
Genetics determines our detox capacity. This will explain to us
that we have a subgroup of children and subgroup of adults
which will not properly handle the overload of toxins and
allergens.
Thimerosal as an allergen, it is worldwide known for years
since 1970's that if you are doing special testing for a
special type of allergy which is lymphocyte mediated allergy,
so-called delay type sensitivity or cellular hypersensitivity,
you find that actually thimerosal is superseding nickel in the
frequency of sensitization worldwide.
If you look at a few studies which have been done comparing
East and West Germany, you see that the East Germany allergy
was very low and it started to rise after those two merged. You
wonder why that is so. It may be that the most strict regime of
vaccination couldn't do something against this.
How do you test for this important allergy to thimerosal
and other things? You do it by so-called patch testing. In
patch testing, you put your putative allergen, the things you
would like to see if you are allergic, on the skin in the back.
I have to say again I read some witnesses from CDC and others
claiming that thimerosal is perfectly safe because the only
thing we could see is its local reaction on the skin. These
people do not remember from the years it is cool that allergy
is never a local phenomena. Allergy is a systemic phenomena,
governed by special types of white blood cells which are
circulating in the body.
If somebody tells you that there is only local reaction,
this is a lie or incompetence but this is not true. Allergy is
a systemic reaction and anywhere in the body where there is
foreign agents, for example, thimerosal, the reaction will
occur and this is inflammatory reaction.
We are doing patch testing. You read on my Web site there
are thousands and thousands and thousands of people patch
testing telling you that especially children are very strongly
sensitized. I think the data from Germany shows that children 8
years or less have actually sensitization rate in those which
are tested, people with skin problems, 20 to 30 percent which
is quite amazing.
The other test which can be used, especially should be used
in children because it is not so good to put the allergen on
the skin because you become resensitized, is so-called blood
test or lymphocyte transformation test. This test has been used
for years in America for detection of people who are sensitized
to different occupational allergens, for example beryllium.
Beryllium specific stimulation tests is used as a golden
standard in America to detect latent sensitization to beryllium
prior the clinical outcome.
So pharmacologic factories and those who are using
beryllium in industry have realized you can save a lot of
suffering like long term sickness and sarcoidosis to detect by
bio markers because now we are looking at the markers of
susceptibility, the people or children which are susceptible to
the agents which others tolerate.
So with Melisa, you take a blood test, the Melisa stands
for optimized lymphocyte proliferation test and memory
lymphocytes. You take a blood sample and you ask if the body
has stored the information of allergy to certain circumstances.
If it is yes, there is a sensitization, then you can see it
objectively by increase in the volume of lymphocytes and you
can measure it objectively. If there is no such allergy, that
means the person is genetically not able to respond, there is
no difference. I will in the end show some cases of this.
If you forget everything, you remember this. Thimerosal and
autoimmunity are the two sides of the one coin. That means you
can never separate. Why is this? This is because mercury, not
only mercury, nickel and other metals, will strongly bind to a
certain immunoacid in our body which contain SH groups. These
groups are everywhere. They are in two aminoacids which are
called methionine and cystine and are especially rich in fat
tissues. As you know, the brain is full of fat, so that is why
mercury will go into the brain and it will find there, for
example, in so-called myelin protein. This is the reason why
Dr. Singh can measure increased antibodies, again myelin, in
many of those children.
Since there are physical chemical properties which are
undisputable, mercury will bind in the brain and elsewhere,
where do we find these things? It will go there, it will bind
there and then your genetic susceptibility if you can make it
or not make it will explain why some will be ill while others
will not.
MMR and thimerosal, there is no way I can comprehend that
there is a concern about synergistic adverse effects upon the
immune system of susceptible children if you put those things
together. So you can buy immunosuppression, which is the other
way mercury works, you can lower the threshold of protection
against the virus, meaning in this time there will be
persistent viral infection instead of the limited one.
There is a fact which you may or may not know. This is that
in my country in Sweden, thimerosal has been removed from
vaccines since 1998. One of the reasons for it is a report on
the pharmaco working party of the European Agency for Medical
Products. They basically say that alteration of the immune
system due to mercury could have consequences on the ability of
the host to withstand viral attack.
So Swedish people made a lecture and since I have been
working in toxicology laboratories for 20 years, I know there
is always risk assessment and they decided they don't want to
take the risk.
The conclusion for this general part is yes. I really
believe there is a connection between synergistic effect of
thimerosal and MMR and there is a group of susceptible
individuals which we may detect even prior and they will be
affected and will be ill.
Some were published and some were not. Just to show you how
we work with this, the big guys, lymphocytes, which are now
stimulated, in culture outside the body, this test is a blood
test, and the big guys are lympoblasts and the small ones are
the ones which are not affected.
Since I was talking about patch testing as an instrument or
device to look on the special type of hypersensitivity which
has no counterpart in the serum, we studied these in 1992, we
have taken which have positive patch tests and looked for the
lymphocytes just to prove this is not only back reactions, it
is a systemic reaction driven by lymphocytes.
This woman has a muscle inflammation and she also has been
susceptible to infections and chronic fatigue. She was patch
tested in 1991 and positive to thimerosal. I am looking on
different mercuries because this part goes together, everything
I say now can be actually applied to dental fillings and you
can look on our Web site.
In 1991, she had thimerosal positive patch test, in 1992 we
did Melisa test. This is exposure. We are always looking into
the exposure. From this point of view, she had occupationally
exposed to inorganic mercury, had 17 amalgam fillings, she was
exposed to ointment which contained thimerosal and she received
gamma globulin and other vaccines at least 16 times.
You can see now a diagram of her lymphocyte reactivity to
different metal salts. This can be difficult for you to follow
but the horizontal line shows the line of positivity and the
rest is very, very strongly positive. This is from a published
paper which you can download on the Internet.
This patient has been treated by mercurochrome another
organic mercury. You can see the huge red staples showing
extreme sensitization to mercurochrome but not at all
sensitization to other mercury compounds meaning that both in
patch testing and in lymphocyte testing you an actually see no
cursory activity between inorganic and organic mercury but
there is one cursory activity and this is between ethyl mercury
and methyl mercury, meaning we are very much afraid that any
sort of sensitization to one may cross react and deteriorate
and heighten the response to other ones. They are patch test
results.
Mr. Burton. Doctor, could we submit the rest of your
testimony for the record. We will have questions for you and
you can elaborate then.
Dr. Stejskal. I just would like to finish with the data on
autistic children two of them. This study is done together with
scientists from Center for Pediatric Health in Belgium, Antwerp
from a group of Austrian researchers, from some American
scientists and from some Swedish scientists. The study is still
continuing. I am just showing some case reports.
This is an Austrian guy, 14 years old with mild autism,
lactose intolerance and vaccinations. There is a causal
relationship of vaccines to his deterioration.
The next one shows you the nonresponsiveness to inorganic
mercury, strong reactivity thimerosal, cross reaction to methyl
mercury and no reaction to nickel and cadmium.
This is a Belgian boy, 5 years old, from John Cronenberg a
pediatrician in Antwerp. He was healthy at birth, got first
instance of autism as a baby, strong aggravation of symptoms at
15 to 18 months. He was diagnosed with autism at 11 months of
age. He has digestive problems, food sensitivity, dairy
products, skin lesions, eczema, rashes and irritation from
metallic contact. Mother had dental work during pregnancy.
This is the schedule of vaccination in Belgium. They don't
vaccinate at birth. You are the only ones who do. At 3 months,
4 months, 5 months, 7 months, at 2 years, several vaccines at
once. This is his reactivity. In this case, there is thimerosal
and methyl mercury.
In conclusion, I would like to say that preliminary data
show the theory that thimerosal containing vaccine may be a co-
factor in the development of autism in genetically susceptible
children. I would like to tell you what I would like to have
for future studies because there is no sense you give millions
and millions to waste the time for nothing.
What we learned about the allergic reactivity to simple
compounds, for example, mercury, regardless if it is inorganic
or organic is that rats and mice are not suitable. One of the
reasons is that they produce their own cyton. It is not a man
and we don't do it. Cyton will protect against metals.
The second thing is you have to do a biomarker screening
for susceptible children and there is a notion from a paper on
our Web site published by my daughter which says the increased
knowledge about individual sensitivity based on genotype and
phenotype variability together with the markers for the
diagnosis of individual susceptibility seems to be the key in
elucidation of operative mechanisms of any autoimmune disease
and also autism.
Thank you.
[The prepared statement of Dr. Stejskal follows:]
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Mr. Burton. Thank you, Doctor. We will have questions for
you later.
Dr. Krigsman.
Dr. Krigsman. Thank you for having me today.
The purpose of my appearance today is to report to the
committee the status of my findings regarding my research into
the intestinal inflammation in autistic children.
We have done a retrospective survey and collected
intestinal biopsy specimens from 43 patients. These 43 patients
were mostly referred from private practitioners who were caring
for their overall autistic medical issues, among them their GI
symptoms. After chronic frustration and inability to control
mainly symptoms of diarrhea and constipation, these patients
were referred to me. Other patients came on their own after
often years of frustration with these symptoms.
Of the GI symptoms that these children have been seen for
mostly it is diarrhea. Many also have constipation. A large
number have both diarrhea and constipation alternating. The
stools are severely malodorous, one of the most common things
we hear parents talk about is the entire house smelling when
these children have a bowel movement in the basement.
Abdominal pain is a very, very common symptom. Most of the
kids are noncommunicative and when they have pain they either
just scream and wail and fall to the floor having tantrums,
unexplainable crying, which could last for half a hour to an
hour.
There are problems sleeping at night, waking up in the
middle of the night screaming. Parents intuitively feel that
these symptoms are due to pain. Sometimes there is an objective
observation as such, holding their belly but more often than
not it is just unexplainable crying.
Abdominal distention is another symptom and poor growth.
The growth is a very interesting issue. I have seen that most
of the children with regressive autism fall in the bottom 10
percentile on the growth charts and weight for age. We have not
found that their height for age is similarly affected. I don't
have an explanation for that but their weight for age, most of
these kids are skinny kids.
The male to female ratio of these 43 patients is 7 to 1.
Who said that these kids are autistic? The diagnosis was made
either by a pediatric neurologist, a developmental pediatrician
and for the most part parents have gone to both and even a
third opinion. In no patient was the diagnosis in dispute.
When I first meet with these patients, we do a routine
evaluation for what is often diarrhea, constipation, we get a
complete blood count, sedimentation rate, chemistry. To most of
you these tests are meaningless; to a gastroenterologist or
parents they are very, very meaningful.
These tests look for specific reasons, specific diagnoses
that can cause these GI symptoms these kids complain of. We do
stool cultures, we look for parasites, we look for occult blood
in the stool. We go over their diet, make major revisions in
their diet, remove carbohydrates, remove sorbitol from their
diet, take them off gluten and casein and pretty much without
exception, none of these interventions help and none of these
tests show anything that would explain why these kids have
chronic diarrhea, constipation and pain.
At that point, I perform a colonoscopy, along with biopsy.
We will look at the entire colon and not just the colon but
more importantly the very end of the small bowel which is the
terminal ileum the area that Dr. Wakefield had described as
involved in these diseases.
I should mention that as recently as 2 years ago, I would
never have put a colonoscope in any of these children. I didn't
feel it was justified or appropriate. I didn't know what I
would be looking for, and I wouldn't do it even though I had
seen quite a number of them. It wasn't until I read Dr.
Wakefield's article of September 2000, American Journal of
Enterology where he described the biopsy findings in over 60
patients and he described a pattern of colonic inflammation
that could explain their symptoms. It wasn't until I read that
article--I read it about seven times actually in one night
because I just couldn't believe it. After reading it over and
over, I decided that I could not find any valid criticism to
the article. I felt justified at that point to perform these
colonoscopies myself.
At the outset, I will say that our findings, which are
independent of Dr. Wakefield's findings, completely support his
explanation and his observations of the abnormalities that are
found in the bowels of these children.
I also performed an upper endoscopy looking at the
esophagus and stomach. I performed that test in those children
who based upon the histories as related by the parent. If those
histories contained abdominal pain, a story of pain, then we
needed to rule out any esophageal or esophagus problems,
stomach problems, intestinal inflammation, infection, and so
forth.
I am showing now a series of slides, actual photographs
that are taken during the colonoscopies to give you a visual
idea of the extent of abnormality that we find. As you will
see, these are not normal.
This first slide is normal. This is a terminal ileum, the
area at the end of the small bowel in a normal patient. What
you can see in the photo on the right, if you look carefully
you will see very small bumps, almost indiscernible. Those are
enlarged lymph nodes but those aren't normally enlarged lymph
nodes. Those are the kind of lymph node enlargements you see in
normal small bowel.
In contrast, the upper row of photographs--can you dim the
lights?
Mr. Burton. She said it would not be good.
Dr. Krigsman. It is a pity because I think the effect would
be greater.
Mr. Burton. You said we cannot dim the lights? The TV
cameras then can't pick up what you are doing and I think that
is important that the American people get a chance to review
all this.
Dr. Krigsman. Absolutely.
The upper row, three across, show marked nodularity, marked
abnormality, numerous small lumps and bumps.
Another patient, same exact finding.
Another patient, you are looking down the tube of the small
bowel, along the right side on the wall those large nodular
bumps. This is not normal.
I call your attention to the upper left and those large
bumpy nodules are the ileal tissue that Dr. Wakefield first
described. On the right side, same patient, a view from a bit
further away, upper right corner.
Another patient, same finding.
Same finding, upper right corner in both those pictures.
Upper right corner on both pictures, those large nodular
bumps.
Same thing, lower left half of the slide.
Same thing from another patient, all over the mucosa of the
ileum there is nodularity.
This particular patient didn't have as much nodularity as
they have swelling. The medial term is edema and is one of the
byproducts of ongoing inflammation.
Same thing. Next patient.
This is a very dramatic photograph. If you look in the
middle downwards in both of those pictures, there is actually
normal mucosa but on both sides of the mid line you see marked
nodularity.
Same thing.
Again.
These are all different patients.
Same thing once again and again.
This patient I included because the lower two photographs
show the same modularity. The upper two photographs are of the
colon and if you look carefully, you will see very small minute
nodules scattered around the mucosa. Not only are these nodules
present in the ileum of these patients, they are also present
scattered throughout the colon.
Same thing.
Same thing.
This patient, the inflammation was so bad in the colon that
he formed what is called a pseudopolyp and the polyp is
recognizable to all. It actually is not really a polyp. What
has happened in this patient is the surrounding tissue is so
inflamed and eroded that what is left is the polyp. Everything
else has eroded around it.
This patient I just saw yesterday. This is the final
patient I will be showing you. This is the oldest patient that
I have done a colonoscopy on. He is 13 years old, autistic. The
regression history is not clear, it has been many years with a
chronic history of one to two bowel movements a day, always
very loose, dismissed by the pediatrician. Over the last 3
months, this child's diarrhea has become uncontrollable, 10 to
15 times per day. He is incontinent all of a sudden. He never
was incontinent. His behavior has been intolerable, aggressive,
throwing tables over and his parents are at the verge of
institutionalizing him because of this recent worsening over
the last 3 or 4 months.
His mother found me out and I did the colonoscopy just
yesterday. This child has the absolute worse colitis I have
ever seen. Most of these kids, when you put the scope up the
colon, the colon appears normal and it is only on biopsy that
you find the abnormalities. In this particular child, the
inflammation was so bad, it has obtained the characteristics of
classic inflammatory bowel disease. If you saw this colon, you
would think this patient has ultrative colitis or Crohn's
disease.
What is interesting about this patient, and Dr. Wakefield
might be interested particularly in this slide, is that the
photo on the left is the bottom of the esophagus and in the
area of about 3 o'clock, you see a white little nodule. That is
an abscess ulcer which is something you see in classic
inflammatory bowel disease. You find those ulcers anywhere in
the GI tract. The photo on the right is the upper esophagus,
the upper esophageal sphincter and you can see there are two
nodules there as well, two more abscess ulcerations as well. I
am wondering if this patient doesn't have just autistic
enterocolitis but actual inflammatory bowel disease. The
biopsies are still pending.
I am going to bypass these slides because I want to point
out that the area of the round ball on the right is the
microscopic view of those big nodules that you saw grossly.
The circle in the middle you see here is the crypt in the
intestine and on the left side of the crypt you see there seems
to be small little black dots. This is a cryptitis, this is one
of the classic findings of bowel inflammation which we have
seen over and over and over in these patients exactly as
described by Dr. Wakefield.
The is the same view. The crypt in the middle in particular
is being invaded by inflammatory cells. It is a very heavy
inflammatory throughout the mucosa.
Same thing here. One more slide.
So looking at our 43 patients, what are our cumulative
results? The percent of patients who had colitis, 65 percent,
meaning either active colitis or chronic colitis, there is a
difference, active colitis, 51 percent of the patients had
that, chronic colitis, 40 percent. Most patients had both which
is why the overall colitis indicator is 65 percent.
A third type of colitis is the cosinophilic colitis, also
described by Dr. Wakefield. We have a 7 percent number, very
similar to his number.
The percentage of patients that had the large nodularities
of the ileum we found to be 90 percent, also very similar to
Dr. Wakefield.
Thirty-five percent of our patients had no form of colitis.
However, even though they did not have colitis or inflammation
on biopsy, all of them without exception had abnormal
lymphnodes so they are not normal even though there is no
colitis.
This is my last slide. I would like to conclude that our
study is ongoing. We have a control group in place. We are
waiting for our formal IRB approval to sit down with one
designated pathologist, the gastrointestinal pathologist
specialist on preagreed-upon pro forma to define the grade of
colitis, types of colitis and with one definition to give you
all the slides we have done from all 43 patients plus our
control group and publish our results and make them known.
The question I would like to explore in our publication is
if you compare regressive autistic children with non-regressive
autistic children, is the incidence of colitis the same or will
it be different? I would like to go over the growth of these
children and compare the growth of children both in regressive
groups and non-regressive groups and see if we find a
percentile difference when we compare the two groups.
Finally, because it is our hypothesis that children with
regressive autism will be those who are most likely to exhibit
growth failure, and also that if we trace back their growth
charts to early infancy, I suspect we will find for the first
year of life, they were growing normally, closer to the median
and somewhere near the onset of their autistic symptoms, I
suspect we are going to find that they began to show evidence
of growth failure along with their autism which suggests that
their autistic symptoms and their GI symptoms are related.
Thank you very much for having me.
[The prepared statement of Dr. Krigsman follows:]
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Dr. Weldon [presiding]. Thank you very much, Dr. Krigsman.
You essentially did what I have been asking the NIH to do for
several years.
Dr. Spitzer, you are recognized for 5 minutes.
Dr. Spitzer. I would like to start by saying my
presentation will attempt to be as objective and as neutral as
I can. I would like in particular to say that despite
disagreement on a narrow set of issues, the CDC, in my
experience of 35 years in epidemiology, has been a great
institution, I am honored that some of my students have been
hired by them, that we have been able to recruit their
colleagues, graduates and people with work experience.
I do not know Dr. Davis or any of the colleagues. I am
looking at the paper and what I find and I would like that
accepted.
The focus of what I am going to talk about is measles
containing vaccines and the risk of inflammatory bowel disease
as published by Dr. Robert Davis and others in the publication
cited in the slide.
The purpose of the study published was to examine the risk
of inflammatory bowel disease following exposure to a measles
containing vaccine. Unfortunately, as implied by my other
colleagues at the table, the use of the results to demonstrate
no link between MMR and autism is what I respectfully consider
to be a misuse of the study and I shall try to explain why.
The fatal flaw of the study is that it is grossly
underpowered. With conventional programs of power calculation,
the calculation of power is somewhat complex but not
controversial and we all do it similarly in various
institutions. The power we calculate is 12 percent where
normally accepted power is on the order of 80 percent and when
you are looking at trying to demonstrate no difference, you
want the power to be higher to avoid what is called a Type II
error as opposed to a Type I error which is what we worry about
in clinical research.
As I say there in what I try to make non-jargon English, a
power of 12 percent means that one has a chance of 88 percent
of declaring no increase in risk if indeed there was a twofold
increase. Just to explain that in a somewhat different way to a
non-statistical or non-epidemiologic audience and to colleagues
in the world of politics, if you mandate a poll and say as you
are facing reelection and so on and you get a poll with a point
estimate that 55 percent in your jurisdiction are in favor of
reelection, in the ones published in newspapers, Time Magazine
and so on, you will see the error is about 3 percent, so
whether you are on the low side, 52 percent or 58 percent, you
will probably get elected.
If it were 40 percent, your estimates go down to the 20's
and up to the 80's and 90's and you have no way from that poll
which had insufficient numbers to predict whether you are going
to get elected or not. It is an underpowered poll as I am
giving the example from this paper.
So the low power results in the wide confidence intervals
you see if not in every estimate of the paper we are talking
about, and in this case 6 percent of the exposed to measles
containing vaccines in the population from which the sample was
drawn, were among the controls they picked. I think their
choice of controls was reasonable and that is what determines
the low power. It is an imbalance, a maldistribution with
exposed and non-exposed in the controls. That low 6 percent is
what demonstrates the low power.
Let me turn to another issue. We can expand with questions,
Mr. Chairman.
A hallmark of science as I have always taught, my
colleagues teach, is replication and/or verification. I think
the replication that Dr. Krigsman has done or the British work
is an enormous contribution to our understanding of the
validity of what went on before and it must be part of the
practice in an evolving challenge like this or other
challenges.
These temples of secrecy, it is more in academia in fact, I
would say, than in organizations like the CDC where this is our
data and false issues such as confidentiality are brought up.
We worked that out decades ago. Ten years ago, I went through
the data base in Saskatchewan and in 4 months we sorted out the
controversy of beta agonists and death in children due to
asthma. It took 4 months, it took $4 million; it would have
taken 5 years and $25 million to do it out in the field. You
can protect the identity of the patients easily in our state of
science today in computer skills and so on.
We should avoid adversarial challenges. There were those
who didn't believe this. We worked together on that. I just
hope we can get past that in these controversies. As I say,
temples of secrecy and adversarial approaches have no room in
population science and most other clinical and related
sciences.
I would agree with what the chairman said earlier, that the
Datalink Data base should be opened to train scientists with
reasonable safeguards. I don't believe in fishing expeditions.
I am sure the colleagues in the CDC worry about that. These at
random searches to see if you can find some dirt if you wish
has no place. This is done seriously in a scientific way but
access must be given to the legitimate concerned academic
population, governmental organization that needs to look,
especially if they are funded through public funds like the
Saskatchewan data base in Canada.
I conclude that the Davis case control study from the
Vaccine Safety Datalink Project cannot determine whether
measles containing vaccines do or do not increase the risk that
we are concerned about. In the 3-years I have been looking at
epidemiologic literature from the entire world, scarcely any of
it allows you to rule out MMR, nor can it rule it in. Part of
the reason is in most jurisdictions where this has been done,
you can't get high power. That is why in a case control study,
my colleagues and I have designed to zero out this problem, we
can't do it in the United States. and in the UK. The population
has been penetrated too much of a degree. It has to be done in
eight other countries just like the NIH supported the WHO
studies in oral contraceptives for exactly the same reasons, an
appropriately so.
Last, this study does not contribute to our understanding
of the relationships between MMR and MCV and autism.
Thank you for your attention.
[The prepared statement of Dr. Spitzer follows:]
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Mr. Burton. Thank you.
I am going to yield to Dr. Weldon because he is a physician
and has some scientific background. I thought I would let him
start off the questions and then I will chime in as we go
through this.
Dr. Weldon. I want to thank all of our witnesses. You have
provided us with a tremendous amount of information. I want to
focus on a couple of important points initially.
If I understand you correctly, Dr. Bradstreet, you have two
cases where you have identified measles virus in the cerebral
spinal fluid in two children with regressive autism?
Dr. Bradstreet. We presented two cases out of the ongoing
investigation.
Dr. Weldon. So you have other cases?
Dr. Bradstreet. Yes, sir, we do.
Dr. Weldon. Have you submitted this for peer review and
publication?
Dr. Bradstreet. No. At this point in time, the data is
preliminary. We are in the process of developing a control base
and replicating the science at which time we will submit it for
peer review. We intend to have, based on the current rate of
acquisition of cases, at least 30 cases to submit.
Dr. Weldon. This is fairly significant, what you presented.
Has anybody done this type of research where they have looked
at kids with regressive autism and done a spinal tap on them
and checked their spinal fluid for evidence of the antibodies
to myelin and basic protein as you described, but more
importantly, viral particles in their cerebral spinal fluid?
Dr. Bradstreet. I believe we are the only people so far who
have done that research.
Dr. Weldon. So you did a research of the medical literature
and you didn't find any evidence that this has been looked at
previously?
Dr. Bradstreet. Not at any point in time in the creation of
the vaccine and the introduction of the vaccine, development of
the safety issues of the vaccine or subsequent to that has
anyone looked for persistence of the measles virus from the
vaccine or autoimmunity in the sense of the brain as it relates
to the vaccine strain. I am not aware of any data to that
effect.
Dr. Weldon. My understanding of pathophysiology for them to
have measles particles in their cerebral spinal fluid suggests
an ongoing encephalitis basically in these kids? Is that what
you are implying to the committee?
Dr. Bradstreet. I think it is very early in terms of
drawing conclusions. There is clearly a persistence of a
detectable viral genome in the brain in these children. There
is the autoimmunity to myelin basic protein and the presence of
abnormal antibodies to measles virus only in the children with
autism. We do not see that in controls.
Before we draw further conclusions, we would love to have
those control spinal fluids looking for the virus. We should
have that within 2 months.
Dr. Weldon. One of these children is your own child.
Dr. Bradstreet. Correct.
Dr. Weldon. Have you tried antiviral therapy in treating
these kids?
Dr. Bradstreet. We have and I would say at this point in
time, it is unpredictable and clearly we need a lot more
research. There is a risk of developing hemolytic anemia in
autism that seems to greatly exceed the risk of hemolytic
anemia from antivirals as published in the literature. I have
been in contact with the manufacturers of various antivirals
and there is something unusual going on in autism that makes
them more susceptible to side effects of antivirals. So it
would not be a way to proceed generally speaking at this time
without some very carefully observed research.
Dr. Weldon. I understand the strain of measles that is in
the vaccine has certain genetic markers that enable researchers
to distinguish it from so-called wild type measles. Are you
making an attempt to do the genetic mapping to see whether this
is wild type measles or the vaccine strain?
Dr. Bradstreet. Certainly that wouldn't be my place, but
the collaborators for us at the various laboratories that are
analyzing the spinal fluid are going to be looking at strain
specificity. The history is very consistent with this being
vaccine onset as opposed to a vaccine failure where wild virus
is getting in and causing these persistent symptoms. Again, we
should know that within 1 to 2 months.
Dr. Weldon. Do these kids have seizures also?
Dr. Bradstreet. A very high percentage have seizures.
Again, this is a select group of children with autism. I am not
trying to extend these conclusions to the entire population.
These are children that have a very well established history
that is very consistent with looking at measles virus or MMR as
a cause of their symptoms.
Dr. Weldon. Thank you, Dr. Bradstreet.
Dr. Krigsman, Dr. Wakefield came under a lot of criticism
when he published his findings, a lot of professional
derogatory statements were made, I believe his credentials as a
research professor have been threatened. Have you encountered
anything like this in your research at all? You are at Mt.
Sinai, correct?
Dr. Krigsman. Lenox Hill Hospital.
Dr. Weldon. By the way, what is your background? Where did
you do your training?
Dr. Krigsman. I trained at Mt. Sinai. I did my pediatric
residency downstate in Brooklyn and my fellowship in pediatric
gastroenterology at Mt. Sinai in Manhattan.
Dr. Weldon. You have published research articles
previously?
Dr. Krigsman. Yes.
Dr. Weldon. And you are a professor of medicine?
Dr. Krigsman. No. I have a position at NYU which is the
academic affiliate of Lenox Hill Hospital.
Dr. Weldon. Have you come under any of the criticism that
Dr. Wakefield encountered?
Dr. Krigsman. Not yet.
Dr. Weldon. Dr. Wakefield, I am curious about this issue of
Dr. Gershon. The ranking member brought it up and I just want
to clarify my understanding of this issue because I was here
when Dr. Gershon testified.
According to Dr. Gershon's statement that measles virus
particles are detectable in the controls in Dr. O'Leary's lab,
do I have that correct?
Dr. Wakefield. That is correct.
Dr. Weldon. And you are contending that there was no
evidence to support the statement made by Dr. Gershon, that Dr.
Gershon didn't look at the data, he made that statement based
on essentially hearsay, what he had heard from somebody else?
Dr. Wakefield. That is my understanding. In fact, the
written data show quite the opposite, that there is substantial
evidence that there was no contamination or no presence of
measles virus in those tissues.
Dr. Weldon. The reason I am bringing up this issue, and I
don't want to get too bogged down in the controversies between
you and Dr. Gershon, but as I understand it, Dr. O'Leary, who
is a well respected viral pathologist, I think he was the
gentleman who first identified Herpes Simplex Type A as the
causative agent for Kaposi's Sarcoma, that he came under a
certain amount of criticism within the British Isles, Great
Britain, England, Ireland and he actually lost some credibility
and some research grants, correct, based on that testimony?
Dr. Wakefield. Yes. Within a week of that testimony, he
lost five grants from the Irish Cancer Society.
Dr. Weldon. From the Irish Cancer Society. I assume that
was very costly to him and his research lab, correct?
Dr. Wakefield. Extremely, both in terms of staff, research
and professional reputation.
Dr. Weldon. Is Dr. O'Leary litigating this issue?
Dr. Wakefield. No. Here, I simply want to put the record
straight and we do not wish to pursue it beyond that. Let us
get on with the science.
Mr. Burton. I just wanted to add I talked to Dr. O'Leary on
the phone and he would have been here today to testify but he
is having some health problems of his own and couldn't be with
us. He stands by what Dr. Wakefield said.
Dr. Weldon. Dr. Spitzer, I get the Archives of Internal
Medicine and I, like a lot of busy doctors, just read the
abstracts and I move on. In the case of the Davis Study, I want
to make sure I understand this correctly.
I took medical statistics in medical school and I also took
it in college. I have looked at this study and do you have the
study?
Dr. Spitzer. Yes, I have it right in front of me, Dr.
Weldon.
Dr. Weldon. I want to get at this issue of the power. Table
III on page 357 in the study reports all inflammatory bowel
disease, the fourth column, broken down by age. They have these
ranges for children who receive the MMR before age 12 months, a
0.61 with a range of 0.15 to 2.45 and then they have all the
others.
As I understand it, 1 basically means it is neutral,
correct?
Dr. Spitzer. Yes.
Dr. Weldon. And then the range, let us take less than 12
months, what they are saying is 0.61 so I guess there is a
suggestion there is a reduction in risk of inflammatory bowel
disease but the range is as low as 0.15 which would be a
dramatic reduction in risk up to almost a two and a halffold
increase?
Dr. Spitzer. Yes.
Dr. Weldon. That tells me this is garbage. I hate to say
that but that is like my pollster telling me your chance of
being reelected is 55 percent with a range of 10 percent to 90
percent.
Dr. Spitzer. I prefer not to use the word but you can't
rule failure to reelect versus reelection in or out on the
basis of the poll.
Dr. Weldon. I think my time has expired and I am sure the
co-authors of the study will take issue with some of this when
they have their opportunity to testify. I yield back.
Thank you.
Mr. Burton. If the gentleman would like, we will come back
for some more questions for this panel.
Mr. Waxman.
Mr. Waxman. I want to point out to the witnesses and the
audience that I have a conflict in schedule because at the same
time of this hearing, there is a Commerce Committee mark up, a
vote on Medicare and Medicaid, so I am trying to go back and
forth.
I wanted to get on the record some points about Dr.
Wakefield's testimony. Dr. Wakefield today testified about an
upcoming scientific presentation in Ireland by Dr. O'Leary. In
this presentation, which is going to take place in July,
scientists are presumably going to claim to have found vaccine
strain measles in the intestines of children with development
disorders. I have a copy of the abstract and want to make it a
part of the record.
[The information referred to follows:]
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Mr. Waxman. The abstract states that the conclusion that
the virus was vaccine strain, which means caused by the
vaccine, is based on one nucleic acid position, No. 7901.
According to the abstract, if the chemical at Position 7901 is
adonine, then the strain is natural measles virus. But if the
chemical is quanine, then the strain is from the vaccine.
According to this abstract, this difference can perfectly
distinguish between natural and vaccine strains of measles.
However, according to the Gene Bank Web site run by the
National Institutes of Health, this isn't true. So what we see
in this abstract, from what we hear from Dr. Wakefield, there
is a real question.
Measles experts have told us that more than 10 natural
measles strains have a quanine at position 7901, even though
the abstract says that only happens in the vaccine strain. If
there are 10 natural measles strains that have that particular
chemical positioning, then this theory doesn't hold up. I have
the names of some of those strains and I expect to even receive
other names which I want to add to the record later on.
I want to ask Dr. Wakefield, are you aware if Dr. O'Leary
has checked the NIH Web site thoroughly before writing his
abstract? If it is true that position 7901 does not distinguish
between natural and vaccine strain measles, would it be fair to
say that the conclusion of the abstract remains unproven?
Dr. Wakefield. The work was based upon a recent publication
by Parkes and colleagues which may well supersede what is
published on the Web site. In that study, they make a clear
distinction between vaccine and wild type strains based upon
that mutation. Other questions on this will have to be referred
to Professor O'Leary himself who can't be here.
Mr. Waxman. I want to ask you whether you know if Dr.
O'Leary checked the NIH Web site thoroughly before writing his
abstract?
Dr. Wakefield. I know for sure that he has checked the Gene
Bank Web site.
Mr. Waxman. If it is true that this position 7901 does not
distinguish between natural and vaccine strain measles, would
it be fair to say that the conclusion of the abstract remains
unproven?
Dr. Wakefield. Yes, it would.
Mr. Waxman. I want to point out that we have been in
contact with Dr. David W.G. Brown, the laboratory director, and
Dr. L. Chen, clinical scientist. They are the head of the World
Health Organization Collaborating Center for Measles in the
United Kingdom. According to Dr. Brown, he says ``The data
presented suggesting the presence of fragments of measles
vaccine in these tissue samples is not scientifically valid.
The author should have reviewed the measles data base fully''
and there are a number of questions he believes should have
been evaluated.
I guess we will have to hear from Dr. O'Leary whether he
did the work that was required in order to come up with the
conclusion beyond a doubt, or whether it is a conclusion that
remains to be unproven. Dr. Brown says ``The approach described
is scientifically flawed and will not reliably discriminate
between wild and vaccine strains.'' He didn't know why the
authors did not review available data or discuss with other
measles groups with experience in this field. ``Sequencing is a
definitive technique to discriminate between wild and vaccine
strains of measles'' and he doesn't know why that wasn't used.
I want to just make the point here in the time I have
available to me that what has now been presented to us is
another conclusion that has been made, but is based on some
unproven information from an abstract that Dr. O'Leary is going
to be submitting, which Dr. Wakefield submits to us as
establishing the point he wants to make.
According to the World Health Organization Collaborator
Center head, Dr. Brown, it is another unproven theory and we
need to have a lot more questions answered about that
particular scientific evaluation.
Mr. Burton. Before you leave, Mr. Waxman, I think we have
some later information on that and we will yield to Dr. Weldon
and maybe he can bring us up to date.
Dr. Weldon. I just want to clarify this issue with Mr.
Waxman.
The abstracts that we are talking about is 12 biopsies, is
that correct, or you haven't seen it? It is not your
publication, is that right? So you are being asked to identify
something you didn't do.
Let me say for the record, I know a little bit about this
issue of single mutation of a single amino acid using it as a
discriminator in determining whether a population, in this case
it was 12 biopsies, are wild type versus their vaccine type.
You get into the statistics of this and maybe Dr. Spitzer may
want to comment on this.
The statistical probability of all 12 happening to get wild
type is extremely low, whereas if that is indeed a marker that
is used for the vaccine type, then the statistical probability
is much, much higher. Yes, you could say that some in that
sample may have acquired it through a wild type but
nonetheless, the statistically higher probability is that this
is vaccine-related measles.
Mr. Burton. Would any of the witnesses care to comment on
that?
Dr. Spitzer. I would really have to look at the specifics
of the study, would have to look at comparison groups,
especially with the low sample of 12 of that sort and have a
bit better understanding than you obviously have Dr. Weldon of
the biology under that. Off the top of my head, I would prefer
not to give an opinion and have to look at the basic data and
the design and some of the biological issues before giving an
opinion.
Dr. Weldon. Just for the record, so the ranking member
understands, when I was an undergraduate, I did molecular
genetics research and specifically we were looking at these
kinds of issues in the research I did, so I am somewhat
familiar with the issue they are publishing on.
Mr. Waxman. Would the gentleman yield?
Dr. Weldon. Yes, I would be happy to yield.
Mr. Waxman. It seems to me the question is either the test
reliably distinguishes vaccine and natural strain or it
doesn't. That really goes to the very heart of this abstract
because if the test does establish that the measles in the gut
of the bowel came from the natural strain or it came from the
vaccine strain, we want to know whether that is established.
I think what Dr. David W.G. Brown, the head of the World
Health Organization Collaborating Center for Measles in the
United Kingdom, is pointing out to us is that he thinks the
conclusion that they distinguish the strain from the vaccine
from other natural sources of strain is not proven by this
abstract because that position of those genes can be the result
of other strains not from the vaccine itself. That is the
essential point that I think remains unsettled. Either it is or
it isn't. Dr. Brown believes it hasn't been established. If in
fact the chemical at position 7901 is from a natural measle
virus or from the strain from the vaccine is the question I
think needs to be established and addressed. I think we have
enough questions here to really feel that we don't have the
conclusion in place.
Mr. Burton. We have to leave for a vote we are not through
with this panel yet. I would just like to say we have gone from
1 in 10,000 children who are autistic and have all these kinds
of variables and complications to 1 in 250 and in some cases,
more than that. Something is causing it and we have to find out
what it is. CDC and FDA and HHS had better get on the ball or
else in 10 years, it may be 1 in 25. Something has to be done.
We have to get to the bottom of this. To sit here and argue
back and forth about one case study or another begs the issue.
The issue is, there is a problem and it has to be solved.
We stand in recess until the call of the gavel. We will be
back in 15 or 20 minutes.
[Recess.]
Mr. Burton. Dr. Stejskal, how many people do you estimate
are allergic to mercury?
Dr. Stejskal. What sort of mercury do you mean? Because
there is a distinction when you talk about allergy, if you talk
about thimerosal or other mercury?
Mr. Burton. Something like thimerosal?
Dr. Stejskal. Then we have to go for patch testing which
has been mostly looked at and I can tell you the numbers are
not insignificant. In children, it seems to be especially often
they do react to thimerosal.
Mr. Burton. Ten percent, 20 percent, 30 percent?
Dr. Stejskal. No, 20 to 30 percent of those which are
tested. In unselected population, that means not coming to
dermatology clinics, but the number which I remember from
Mueller in Sweden, it is about 15 percent.
Mr. Burton. Fifteen percent. So anywhere from 15 to 30
percent in the children are allergic to thimerosal?
Dr. Stejskal. Yes.
Mr. Burton. Dr. Krigsman, you did how many colonoscopies on
those children?
Dr. Krigsman. We have 43 results back from 43 patients. One
patient had to be colonoscoped twice because of unexplainable
worsening of symptoms. In addition to the 43 patients we have
seen, 5 have been scoped already and those biopsy results are
still pending.
Mr. Burton. I know you can't make a categorical statement
about this but in your opinion, do you think this was caused by
just regular measles virus or do you think it was caused by the
vaccines? What is your theory on this?
Dr. Krigsman. I read the same papers everyone else has read
and what I would like to do and what we plan on doing is
attempt to replicate what Dr. Wakefield's group has published.
We have everything in place, we have our lab, we have been in
contact with the laboratories that have performed this test, we
have the details of the assay, we have the patients. All we are
waiting for now is the hospital's IRB approval. The day after
we get that, we start.
Mr. Burton. So you prefer not to theorize until you get the
actual study?
Dr. Krigsman. Until I do it myself, I don't know.
Mr. Burton. We would like to have that. If you would send
that to me for the record when you get it, we think that would
be not insignificant. I think what you have done today by
showing your results so far is very significant. I think
finding the measles virus in the spinal fluid is also a very
significant finding. If I were over at CDC or FDA, I think I
would want to start replicating those studies right away over
there before the private sector does it and they are proven
wrong.
It seems to me that our health agencies ought to be ahead
of the game instead of standing around waiting for the
basketball game to be over and then say, oh, well, we had
better do something about that.
I don't think Dr. Weldon had anymore questions for this
panel, did he? I think we have pretty much covered everything
with you. You have been a very good panel, you have been very
patient and we appreciate your being with us. We have one more
question.
Do you believe the CDC statistical studies can dismiss the
clinical findings? That is what the Associated Press has said
and what Reuters News Service has said. Do you believe that the
CDC statistical studies can dismiss the clinical findings?
Dr. Bradstreet. If I might take that up as a clinician
treating about 1,500 children with autism between myself and my
partner, a pediatrician. One of the disturbing things for me in
the way this has been handled by the media is I have a patient,
and I only take care of one patient at a time, even though I
have 1,500 in my practice, who has a definable, biological
problem. I can measuer it. I can get a laboratory test and
measure autoimmunity to brain, I can find excessive amounts of
mercury and I can send off biopsies and find measles virus.
We could debate whether that is the vaccine strain or the
wild strain but we don't seem to be debating the fact that it
is measles virus that is persisting in these children. So we
have a definable biological problem that must be addressed as a
clinician. The problem is that medicine has not yet given me as
a clinician the tools to deal with most of these problems. So
we need a lot more data that would allow me to treat.
Do the statistics somehow magically erase the laboratory
results and the clinical findings and the abdominal pain and
the history and the chronic diarrhea that my patients are
experiencing? Absolutely not.
Mr. Burton. Anyone else want to comment? Dr. Wakefield.
Dr. Wakefield. Just to say the statistical studies of the
CDC and others have actually tested the wrong hypothesis and
this point was made in the paper that was commissioned by the
Institute of Medicine for the review on MMR last year. Until
they set about testing the correct hypothesis for a
relationship between vaccines, be they thimerosal or MMR or
both and autism, then they will continue to come up with
ambiguous or negative conclusions.
Mr. Burton. Anyone else?
Dr. Stejskal. I would like you to put up the overhead and I
would stress again that I am sure case control studies when you
just pull up all autistic children against all controls which
may be asymptomatic, will have us power to tell you anything.
The effect of risk factor may be diluted. So if we are now
talking about mercury sensitization or weak mercury
detoxification as a factor in these, normal case control study
will not catch this. This paper is saying the effect of risk
factor may be diluted in heterogeneous population. Analysis has
to be based on the clinical markers of susceptibility either
for toxicity or biology but on the biomarkers. These biomarkers
can be enzymes for detoxification. You have to select patients,
autistic children, for this and then you have to do allergy
studies. So analysis based on clinical markers of
susceptibility which are phenotype markers but also genetic
markers if they are available and this may be one way to
separate causes and identify specific and environmental risk
factors.
I think this is very important that the new studies which
should be set up would be done so we can really measure and
find the causes.
Dr. Weldon. I just have one quick followup question. One of
the issues I have had a bit of a problem with over the years we
have looked at this issue is we hear about mercury and MMR and
it is hard to take some of this credibly with people talking
about various different causes of autism related to vaccines.
If I understand correctly, Dr. Stejskal, and you two
gentlemen talked about this as well, there may be a population
of kids out there that are at some sort of genetic
predisposition and mercury is somehow like an enhancing agent
to allow the measles component of the MMR to cause this
abnormal reaction that we are describing as autistic colitis,
regressive autism, correct?
Dr. Stejskal. Yes. There is evidence from animal studies,
as I told you, which are quoted in this paper of the Working
Party of the European Agency who says in studies this is the
case. Mercury will compromise the immune system.
Dr. Weldon. The reason ethyl mercury or thimerosal was
removed first from topical agents by FDA and then later ordered
to be removed from all vaccines is because it was causing a
hypersensitivity reaction?
Dr. Stejskal. That is right. The same with penicillin and
sulfur drugs, that was the same thing. A topical application is
always the most frequent one for produce of sensitization which
doesn't mean that other applications don't.
Dr. Bradstreet. If I might add, the data is quite
compelling that in autism we see autoantibodies to myelin basic
protein. We have been able to verify Dr. Singh's work with
multiple different commercial clinical laboratories and it is
clearly reproducible. So we know we have a very large
percentage of children with autism who make antibodies to
myelin basic protein. Interestingly enough, one of the well
documented biomarkers for mercury toxicity, also a biomarker
for lead toxicity, are antibodies to myelin basic protein.
The intriguing thing for me is the way that mercury alters
the immune response, changing it. So rather than a normal, let
us get rid of the virus response, ut changes to an autoimmune
response and allows for viral persistence. A response which is
exactly what we have measured and presented at the American
Society of Microbiology meeting, where there is evidence for
viral persistence and evidence for autoimmunity in the presence
of viral persistence. That I think is quite compelling that
there is, in fact, a priming event where thimerosal, the
mercury containing component, and we haven't talked about
aluminum but I think aluminum in the vaccines is a very
important part of that priming event as well, as are other
vaccine constituents, set up the child's immune system so when
the live virus is provided, and I think the route of
administration, jabbing the kid as opposed to natural barrier
mechanisms of administration is important too, clearly makes a
difference in the child's response. I think the child then is
set up for viral persistence and the host of complications we
see as a result of that.
Dr. Weldon. It is safe to say that the work in this area is
very, very preliminary?
Dr. Bradstreet. Indeed.
Mr. Burton. I think that covers the first panel. Thank you
very much once again. You are welcome to stay around and listen
to the testimony of the people from the health agencies if you
so choose.
We will now welcome the second panel: Dr. Roger Bernier of
the Centers for Disease Control and Prevention and those
accompanying you, Dr. Robert Chen, Dr. Frank DeStefano, Dr.
Stephen Foote from NIH and Dr. William Egan from the FDA. Would
you please come forward?
Can I ask you to please rise to be sworn, please?
[Witnesses sworn.]
Mr. Burton. I understand some of you have an opening
statement? Dr. Bernier, you have an opening statement?
Dr. Bernier. Yes, Mr. Chairman.
Mr. Burton. Proceed.
STATEMENT OF DR. ROGER BERNIER, ASSOCIATE DIRECTOR FOR SCIENCE,
OFFICE OF DIRECTOR, CENTERS FOR DISEASE CONTROL AND PREVENTION,
ACCOMPANIED BY DR. WILLIAM EGAN, FOOD AND DRUG ADMINISTRATION;
DR. STEPHEN FOOTE, NATIONAL INSTITUTES OF HEALTH; AND DR. FRANK
DESTEFANO AND DR. ROBERT CHEN, CDC
Dr. Bernier. Good afternoon, Mr. Chairman and other members
of the committee.
I am Dr. Roger Bernier from the Centers for Disease Control
and Prevention. Thank you for the opportunity to testify today
on CDC's activities on vaccine safety research. I am
accompanied today by Dr. William Egan of the Food and Drug
Administration, Dr. Stephen Foote from the National Institutes
of Health; and at your request, Dr. Robert Chen and Dr. Frank
DeStefano from CDC are also here to respond to questions.
Autism spectrum disorders are a group of lifelong
developmental disabilities caused by an abnormality of the
brain. Most recent data suggests that between 2 and 6 children
per 1,000 have ASD or autism spectrum disorders. The impact on
families of children diagnosed with ASD is tremendous. The
Department of Health and Human Services is dedicated to finding
the answer to what causes autism and how it can be prevented.
While my focus today is on vaccine safety related issues, it
should be noted that HHS has implemented an Interagency Autism
Coordinating Committee. The activities of this committee
highlight the large scale coordinated response that has been
launched by HHS in order to understand, prevent and treat
autism.
Some parents, researchers and others have expressed
concerns about potential links between autism and vaccines
currently being used in the United States, focusing primarily
on thimerosal, a preservative in some vaccines and second, on
measles, mumps and rubella vaccine.
In mid-1999, the U.S. Public Health Service agencies,
including NIH, FDA, HRSA and CDC took action working
collaboratively with the American Academy of Pediatrics, the
American Academy of Family Physicians, and vaccine
manufacturers to begin removing thimerosal from the vaccine
supply. While the risk of harm was only theoretical, the
decision was made as a precautionary measure in order to reduce
overall mercury exposure of infants. As a result of this
action, all manufacturers are now producing only vaccines that
are free of thimerosal or have only trace amounts for routine
infant immunization.
The suggestion that MMR vaccine, which has never contained
thimerosal, triggers autism was initially based on some reports
of cases of autism in which parents noted the onset of autistic
behaviors shortly after MMR vaccination. Over the last few
years, a number of studies have been performed in countries
around the world to address this issue. Systematic scientific
reviews by some of the most prestigious medical bodies around
the world, including the Medical Research Council of the UK,
the American Academy of Pediatrics and the Institute of
Medicine of the National Academy of Sciences in the United
States have unanimously concluded that evidence does not
support a relationship between MMR and autism.
CDC is actively involved in detecting and investigating
vaccine safety concerns and supporting a wide range of vaccine
safety research to address safety questions. We talked earlier
about the VSD. In order to enhance the understanding of rare,
adverse effects of vaccines, CDC did develop the VSD in 1990.
The project is a collaborative effort which utilizes the data
bases of eight large HMOs. The data base contains comprehensive
medical and immunization histories of approximately 7.5 million
children and adults. The VSD enables vaccine safety research
studies comparing evidence of health problems between
unvaccinated and vaccinated people.
Another critical part of our vaccine safety effort is the
objective scientific evaluation of safety concerns by
independent experts. In this report regarding association
between MMR vaccine and autism spectrum disorder in April 2001,
the IOM made several recommendations regarding future research.
CDC takes this issue very seriously and is currently funding
five separate research studies that address the recommendations
from the IOM. These are described in my written testimony.
In October 2001, the IOM Committee published a report on
the possible association between thimerosal containing vaccines
and neurodevelopmental disorders. In this report, the IOM
concluded, ``The evidence is inadequate to accept or reject a
causal relationship between exposure to thimerosal from
childhood vaccines and the neurodevelopmental disorders of
autism, ADHD and speech or language delay.'' The IOM made
several recommendations regarding future research on this topic
and CDC takes this issue very seriously and has undertaken six
separate studies that address the IOM recommendations. These
are also described in my written testimony.
We remain vigilant to assure the safety of vaccines. We
must also remember that vaccines benefit the public by
protecting persons from the consequences of infectious
diseases. Continued high U.S. vaccination rates are crucial to
prevent the spread of diseases such as measles, pertussis and
rubella among U.S. children. Vaccines are cited as one of the
greatest achievements of biomedical science and public health
in the 20th century. We can point to the remarkable success we
have had in controlling numerous infectious diseases which used
to be widely prevalent in the United States including polio,
measles, pertussis and others. In fact, several of these
vaccine preventable infectious diseases are known to cause
developmental disabilities including hemophalous influenza Type
B or Hib vaccine and congenital rubella syndrome, one of the
few known causes of autism. Rubella vaccine, by preventing CRS,
thus prevents some cases of autism. Prior to routine
immunization with Hib vaccine, of young children who developed
Hib meningitis, 5 percent died and another 15 to 30 percent
were left with residual brain damage leading to language
disorders and mental retardation.
In conclusion, CDC remains committed to collecting accurate
data on the prevalence of autism and conducting studies on
vaccine safety. Research is already underway and more is
planned to look at the relationship between the MMR vaccine and
autism, and also on thimerosal related questions. We want each
child to be born healthy and to grow and develop normally so
that they are able to lead productive lives. Vaccines are one
of our most valuable weapons against disease and have afforded
us one of our proudest achievements in public health.
Thank you, Mr. Chairman and members of the committee for
the opportunity to testify before you today. I would be happy
to answer any questions you might have.
[The prepared statement of Dr. Bernier follows:]
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Mr. Burton. I will start the questioning.
How do you account for the epidemic of autism? It has gone
from 1 in 10,000 and maybe it was because of reporting, maybe
it was more than that, maybe it was 1 in 5,000 but now HHS says
it is 1 in 250. How do you account for the epidemic, the growth
in the epidemic?
Dr. Bernier. I will let my colleague, Dr. DeStefano, answer
that because he works in the Center for Birth Defects and
Developmental Disabilities where the autism research is carried
out.
Dr. DeStefano. I think this is a complex issue that we are
studying as well as NIH to try to resolve what is going on. It
is clear from current data that more children and other people
do have autism than was felt to be the case in the past.
Current estimates are that between 2 and 6 per 1,000 children
have an autism spectrum disorder and that is probably tenfold
higher than what was believed in earlier years.
The question is, is this an increase or is it due to better
ascertainment, changes in diagnostic criteria, etc. We are
trying to get a better estimate and are funding studies at CDC
and several States to determine what the prevalence of autism
is, if there is geographic variability, and to be able to
monitor its occurrence in the future. Unfortunately data used
different criteria and there was different knowledge of autism
in the past. I don't believe we are ever going to be able to
resolve definitively whether this has been an increase due to
changes in diagnostic criteria and ascertainment versus a true
increase in disease occurrence. We will get some leads on that
as we better determine what the causes of autism are.
Mr. Burton. That is a long way of saying you don't know why
there is this tremendous increase?
Dr. DeStefano. That is right. That is why there is research
going on to try to determine its causes.
Mr. Burton. Have you replicated any of the studies of the
doctors we had before the committee today, Dr. Wakefield or any
of the others? Has CDC or HHS tried to replicate their studies?
Dr. Bernier. I think in some of these 11 studies that I
alluded to, 5 relating to MMR and autism and 6 that are
thimerosal related. There is going to be an effort led by CDC
to try to create a multi-centered laboratory study that will
examine some of the same questions that Dr. Wakefield and
others have looked at, so yes, that effort is underway and good
progress has been made in trying to organize this kind of
multi-centered study but we are trying to do this in such a way
that we can overcome some of the shortcomings or limitations
that may have existed on some of the earlier work.
Mr. Burton. So what you are saying is you are in the
process of doing it now but you have not yet done it?
Dr. Bernier. Specifically relating to the work that Dr.
Wakefield and his colleagues have done, that is correct, but
there is a lot of other work that has been done and has been
reviewed by the IOM and these other committees that I have
talked about. I wouldn't want to leave the impression that
there is a big void of information. I wouldn't want to leave
the impression that we know everything we should know and I
certainly don't want to leave the impression that there is a
void either.
Mr. Burton. How long have we been talking about this? How
many times have I had people from HHS and FDA up here? It has
been a couple of years, hasn't it?
Dr. Bernier. It has been often.
Mr. Burton. Two or 3 years? Yes, it has been often. Now you
are starting to look into it. I want to tell you we appreciate
that and I am sorry it took so much prodding to get it started.
We were talking about the vaccine safety datalink. For 2
years now we have tried to get that information so that other
doctors and scientists who are not connected to our health
agencies, who have credentials, could start using that
information to do studies on their own. We were told in January
or February that was going to be made public. Before this
hearing, we asked why it had not yet been made available to
responsible people in the scientific community and we were
told, it has been made available. I didn't know it. Did you
make any kind of report to the public that you had announced
this in a press release or anything?
Dr. Chen. I think several members of the audience were
present at the meeting and we discussed several issues. The VSD
project is a very important and unusual project that contains
the personal medical records of about 7.5 million persons in
the United States. With all the public concern about data
privacy, it is very important to work out a process in which we
can balance the need to respect the privacy of these
individual's medical records on the one hand, as well as the
desire for us to have researchers be able to independently look
at the data.
It has taken us 2 years to develop a process, when we first
approached the HMOs, there were severe concerns by all of them
that they would not agree to this and that they would withdraw
from the project. So we have had to take the time to work out a
compromise in which they would still be willing to participate
in this partnership with the Government in terms of our ability
to look at data safety issues as well as meet the needs of the
HMOs in terms of protecting their privacy. I think that answers
the question in terms of why it has taken time, so we have come
from where each of the HMOs, not only the principal
investigators, but also their governing bodies were opposed to
this idea and we have worked with each of them to convince them
to come around the other way, to accept the research data
center. This convinving is what has taken a considerable amount
of time.
Mr. Burton. Let me pursue this. So in February, you had a
meeting and other CDC employees were involved with committee
staff and they discussed the release of the Vaccine Safety
Datalink raw data to researchers. At that meeting, CDC provided
a draft proposal. It is in your file there, exhibit No. 1 for
researchers to access the VSD data. At that time, the staff was
told the project was ready to go in February.
[Exhibit 1 follows:]
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Dr. Chen. That is correct.
Mr. Burton. We did not receive up to this meeting today a
press release or an advertisement in any medical journal or on
any CDC Web site regarding this new program. If you are going
to make an announcement, how do you propose to let anybody know
unless you tell us?
Dr. Chen. As I mentioned at the meeting to the people that
were present, this is the first time we have tried to develop
this mechanism with the National Center for Health Statistics.
It is a pilot project using their Research Data Center which
historically has not made this type of personal medical records
available for public use. This center has been used only for
public access to results of national health interview surveys,
generally conducted kind of over the telephone, where people
are willing to answer questions about their health status. This
is a pilot process, so until we work out all the potential
concerns through the first couple of test projects, it is our
sense that it would be premature to widely advertise it.
Mr. Burton. With the quantum leaps that we have seen in
technology, there is not any real risk if you don't want the
researchers from the outside to know who the individuals are on
the data. You can do that, you can protect the privacy of those
individuals. You can make sure there is no public announcement
about that.
Dr. Chen. Unfortunately, that turns out not to be really
feasible in this data base. If you could imagine that for any
vaccine safety study, you need several parameters that are key
to be able to conduct the analysis. You need to know the date
of birth of that individual, the date of vaccination of that
person and any medical visits and what diagnoses they had. You
need those elements in order to be able to do your analysis. It
turns out that with the key variable on date of birth, so this
was one of the major concerns expressed by one of our HMOs in
Colorado, the principal investigators, his daughter recently
had a sprained ankle and therefore, he posed hypothetically to
his analyst that if you attended a birthday party and knew my
daughter's date of birth and you also happened to find out the
child had a sprained ankle the previous week, could you find
this child? In fact, he very easily was able to find the
medical record of the PI's daughter.
Mr. Burton. I see where you are going. We are talking about
how many people, 6 million?
Dr. Chen. 7.5 million.
Mr. Burton. And you are concerned because there is a
sprained ankle, somebody goes to a party, they might be able to
tell by using the birthdate who this person was.
Dr. Bernier. Mr. Chairman, may I interject, if I may? I
want to put on the record very clearly that CDC does support
sharing information and trying to work transparently which I
think is where you have been trying to get us to go.
Mr. Burton. What I am trying to find out right now is why
when we were told in February they were going to release this,
every day is important to people who are going through these
problems, my grandson, my granddaughter, all these people out
here who have kids who are autistic, the people whose kids are
becoming autistic, every day is important to them. When we were
told in February we were going to get information and here we
are at the end of June and haven't received it, and we have
been told, it was made public a long time ago but nobody knew
it, that is important. That is what I am trying to get at here.
If you made a decision, why didn't you tell us? Why didn't we
know about it? Why didn't all these people and the scientific
community that wanted to get started on this, why weren't they
told about it?
Dr. Bernier. First of all, we have been trying to strike
the right balance between the interests of all the concerned
parties. That is part of the reason. The other thing is this is
new for us. We are not interested in highly publicizing
something where it is a pilot type of project. When we can iron
out the wrinkles, we potentially will be in a position to make
this more available. Part of this is this is a new pilot
project and there have been efforts to try, as Dr. Chen alluded
to, to protect the cooperation of the HMOs. We have the
proprietary interests of the HMOs and the privacy rights of the
patients, so we are trying to strike a balance and we are
trying to make this work as smoothly as possible. We don't know
all of the issues we will confront when we do bring in these
researchers to reanalyze some of the studies we have done. So
we are trying to move cautiously so that we can do so, but we
will get to where you are going for people who want to
reanalyze studies that CDC has done and the VSD.
Mr. Burton. I have more questions but I will yield to my
colleagues. As I said before as I yield to Dr. Weldon, we all
want you to be cautious, we don't want to make mistakes. We all
support vaccinations done in a responsible way because it has
protected the health of this country, but you have people every
day starting to suffer. There are huge quantities of people who
have children now suffering under these diseases. The quicker
we move, the better and the more people that get involved in
the research, the better. Having outside responsible scientists
having this data so they can get started on it quickly is very,
very important.
Dr. Weldon.
Dr. Weldon. Let me start by saying to you, Dr. Bernier, we
all support the vaccine program. I am a physician and I
vaccinate hundreds and hundreds of people every year in my
practice. We all recognize the tremendous accomplishment of the
vaccine program in preventing death and morbidity in the United
States and world over.
We have had a lot of hearings on this issue over the years.
A lot of people from the vaccine community come forward and
point out all of that over and over again. We don't really
question any of that. Our concern is that there has been
clinical evidence that there are some very serious problems
with our vaccine program and that officials in the United
States and officials in Great Britain have been trying to avoid
addressing them straight up.
To cite as one example, Dr. Bradstreet did a chelation on
his kid and chelated out a mountain of mercury from his kid. In
other panels, we had physicians with autistic kids who did hair
analysis on their kids and discovered they had toxic mercury
levels.
I am very glad you are getting around to the studies now
and I am very, very pleased you said you have six studies going
on but I want to underscore that we all support the vaccine
program, we all know it saves millions of lives, we all want to
see it continue. Credibility is also one of the other issues at
stake here. It is not just the science of the matter, it is the
credibility of our vaccine program.
The last thing I personally want to see is that public
confidence gets undermined like it has been in Great Britain
and you have thousands of families refusing the vaccine now. As
I understand, you have outbreaks of measles going on over
there. I would like to see us handle it better. Let me say, and
you can take this back to your bosses, one of the things I
continue to be very, very disappointed about is the amount of
money that is being thrown at this issue. We have about a
million people with HIV AIDS, the CDC budget for HIV AIDS is
$932 million, almost $1 billion for HIV AIDS for a million
people. We have about half a million people, kids, with autism
and the CDC budget is about $10 or $11 million. We have to
start putting the resources to this problem to address this
issue.
The access to the data, you guys have to work through that
problem and you have to allow skeptical people to look at the
data because the impression is being generated that there is a
cover up going on. I want to say that this study lends credence
to the concern of there being a cover up. Dr. Chen, I would
love for you to respond to my question. You have a claim in
here in your conclusions, ``Vaccination with MMR and other
measles containing viruses or the timing of the vaccination
early in life does not increase the risk of inflammatory bowel
disease.'' You aren't the principal author, it was Robert Davis
and there are 10 different authors here, so maybe you didn't
write that conclusion.
The statisticians are telling us you don't have the power
in this study to make that sort of claim. What is really
disturbing to me is now in clinical evidence, sort of the Bible
in medicine, this study is being quoted in clinical evidence
that there is no relationship but the statisticians I have
talked with tell me the data doesn't support the claim at all.
This suggests again that you are circling the wagons and not
really addressing the issues straight up, honestly.
Dr. Chen. Dr. Weldon, let me address some of your points.
If you take a look at my record over the years, I have done
everything I can to build the infrastructure that is needed for
us to address some of these issues. I started the Vaccine
Adverse Event Reporting System [VAERS], I started the Vaccine
Safety Datalink Project and I think in retrospect, part of our
challenge in the field of vaccinology is that there was one
additional missing piece of the infrastructure which in part
has created an unnecessary gulf between the clinicians and the
population scientists.
If you think about it, adverse events obviously occur
rarely so that any particular doctor reporting to VAERS would
be pretty much doing so for the very first time. Our difficulty
has been finding a way in which these types of cases can be
assessed in a standardized way. The analogy would be that we do
not expect the average primary care physician to be able to
diagnose and treat a rare type of leukemia on their own. We
create a subspecialty of hematology oncology which over time,
as a sub specialty, is able to make progress on these rare
outcomes. The analogous situations with vaccine safety is that
by and large these events are rare. What we need is a tertiary
infra-structure to be able to study them. We have just started
the Clinical Immunization Safety Assessment Centers in this
current fiscal year. So I think we will have a mechanism to
conduct the type of research needed to bridge between the
population and the individual level.
Dr. Weldon. Let us talk technical stuff here. The issue is
power and the problem with the power in this study, the power
calculation renders the study invalid because you do not have
enough people in your control group who were not vaccinated and
the only way we can get a statistically valid study because the
penetration of this vaccine is so extremely high is that we
would literally have to have a multinational effort to try to
address the question you attempted to answer in this study
which you really didn't answer.
Dr. Chen. I agree that this was one study and it provides
evidence; that the more studies are conducted, the better the
evidence is, they are replicated.
Dr. DeStefano. I am a co-author of this paper. The low
power that was alluded to earlier kind of missed the main point
of this paper. It combined all measles vaccine into one group
and therefore, we found that 94 percent were vaccinated. By
time of this study, the hypothesis with IBD and measles vaccine
had shifted, to it is MMR vaccine that is the culprit. Before
that there had been studies done looking at single antigen
measles vaccine, one done by Montgomery, which Dr. Wakefield is
co-author, a cohort study of a 1970 British birth cohort. They
did not find any association with single antigen measles
vaccine. Similarly a case control study by Feeney did not find
an association with single antigen measles vaccine.
Subsequently the study by Montgomery was the one in which
there were two cases in which the individuals, again with long
term follow up to about age 26, about two cases where the
individuals had wild type measles disease and mumps disease in
the same year. Those two cases had a high relative risk. I
think it was from that finding that the theory or hypothesis
that having the two antigens exposure at the same time may be
more detrimental. From there, I think that is part of the
evidence that it is combined measles/mumps/rubella vaccine that
is really the more dangerous combination and calls for single
antigen vaccine.
At the time of this study, the main new information issued
or addressed was MMR vaccine. If you will look in this study,
the proportion vaccinated with MMR was 66 percent. I think the
relevant table is Table II where we are looking at ever
vaccinating with MMR vaccine and you will see that the upper
end of the 95 percent confidence interval for inflammatory
bowel disease is 1.69. We can be over 95 percent confident that
the relative risk for inflammatory bowel disease in this
population associated with MMR is well below 2.
Dr. Weldon. We have a range of 0.21 to 1.69.
Dr. Destefano. This is not a flat range. You have to look
at the odds ratio of 0.59 because that is our best estimate. If
you would repeat this study, it would be statistically like a
bell shaped curve, most of the results would be around 0.59.
You may have a few out there around 1.6 or maybe a few down by
0.2 but they are mainly going to cluster, our best estimate is
0.6, and it is for MMR. I agree we were much more limited in
looking at Table III with the specific ages of vaccination and
that we are more limited in looking at Crohn's Disease or
ulcerative colitis. I think our power was reasonable or at
least as the confidence intervals would suggest to address the
main issue that was extant at the time.
Dr. Weldon. Let me reclaim my time here. The issue is this
is a relatively low probability event. The data suggests the
vast majority of girls can take this vaccine and it is probably
less than 1 percent. If this hypothesis is correct that MMR
alone or MMR somehow interacting with mercury is causing
regressive autism associated with inflammatory bowel disease or
autistic enterocolitis, the data is that it may be 1 percent of
boys and it is well below 1 percent of girls, maybe on the
order of 0.2 percent or less of girls. So even an odds ratio
that you are putting forward here in Table II, I will give you
credit, of 1.69 doesn't answer the question. On the basis of
the data you provided here, you cannot substantiate the
conclusion.
Frankly, I have been reading the archives for years, not
the archives of Pediatric and Adolescent Medicine, the archives
of Internal Medicine, but it is published by the same
publisher, the AMA, and I am surprised this would be accepted
for publication and I am even more disturbed that data is being
cited in other publications as further evidence that there is
no relationship. Meanwhile, we have more and more clinical
studies.
We heard from another researcher totally unaffiliated with
Dr. Wakefield but basically substantiating Dr. Wakefield's
findings and now we have more disturbing development of a
researcher telling us he is finding measles in the cerebral
spinal fluid in these kids. Maybe the CDC is the wrong agency
to be addressing these questions. None of you are with NIH,
correct? You are with NIH.
Dr. Foote. Yes.
Dr. Weldon. The NIH budget I think is even more disturbing.
You have in 2003, $2.7 billion on HIV AIDS related research,
which I don't quibble with, it is a terrible problem but $70
million, you have 500,000 people with autism and 1 million
people with AIDS, why don't we just apply the dollars. I have
heard you say you have to get quality research and you can't
just throw money out, that you want quality, but I know enough
about research that if you dangle the money in front of them,
the quality research will start coming forward. There are a lot
of researchers who will say I can do that, why don't we get
answers to some of these questions?
Dr. Foote. As we discussed several weeks ago when I last
testified before this committee, even in that time we have made
strides toward funding our first large autism research centers
and there will be a formal announcement about that in several
weeks. In those centers, for example, is where the kind of
training will occur that will allow young investigators to
develop skills, to develop quality grant applications to design
very rigorous experiments to undertake these issues.
Your message is well taken that there is a need for
biomarkers for this disorder. There is a need for more clinical
investigation and we have put the money on the table, we are
working with investigators with a great deal of technical
assistance to them about how to prepare grant applications and
so on.
Dr. Weldon. I want to underscore a very, very important
point in all this. I don't mean to keep picking on AIDS, but
you are going to have another dramatic increase in your
funding. The President wants it, the House and Senate all want
it. You are going to get hundreds of millions of dollars more.
Keeping this kind of a ratio, you have to start applying
disproportionately more money to autism so we can get answers
to some of these questions. One of the reasons I feel so
strongly about this is unlike AIDS, where it is clearly a
behavioral related disease, these kids may be getting this from
a Government mandated vaccination and if we get answers to some
of these questions, we may be able to prevent it whereas in the
case of AIDS, we can't really prevent it because it is
behaviorally related. It is not something mandated by the
Government that has caused it. So a shift in priorities can
have a dramatic impact.
I am going to yield. I just want an answer for the record.
The issue brought up by the ranking member on using various
coding regions in the RNA and in the proteins as biomarkers to
determine whether or not there is a wild type versus vaccine
strain, I want to introduce for the record a research article
published by Dr. Christopher L. Parks entitled, ``Analysis of
Noncoding Regions of Measles Virus Strains in the Edmonston
Vaccine Lineage.''
I yield back.
Mr. Burton. Without objection, we will submit that for the
record. We also have another article. We will put those in the
record.
[The information referred to follows:]
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Mr. Burton. Mrs. Morella, do you have some questions?
Mrs. Morella. Thank you for this hearing and the
continuation of a series.
Dr. Weldon makes exceedingly great points by virtue of his
experience and knowledge. I agree with him that we should not
be equating HIV AIDS with the money going into this research
either. Let us just contribute the money to all of the
research. I know he doesn't mean to say we take away from one
with the other.
I am going to ask a series of questions of Dr. Chen. Dr.
Chen, in the U.S. medical community, studies that have been
done by CDC researchers are given a great deal of credence,
aren't they?
Dr. Chen. I hope so.
Mrs. Morella. Internationally, such studies tend to be
viewed as the opinion of the Government, correct?
Dr. Chen. You would have to ask those people. Again, we try
to do the best science possible.
Mrs. Morella. Generally, medical authorities, particularly
those in the international community tend not to distinguish
between CDC employees publishing research and the CDC's
official position, correct?
Dr. Chen. Again, I have not done a survey to look at that.
Mrs. Morella. Isn't it true that HHS requires or perhaps
should require that CDC ensure that its research regarding
vaccines, for example, is of the highest caliber, is not
misleading, and that a published study actually answers the
question being asked?
Dr. Chen. No, I think all studies have their strengths and
weaknesses as seen by the discussion this morning. All we can
do for any particular study is do our best to see what we can
answer with the particular study design and address the
strengths and weaknesses in the discussion.
Mrs. Morella. So if a given CDC study can't reach a
conclusion, the CDC and the article needs to explicitly say so,
correct?
Dr. Chen. Again, in any particular discussion, hopefully we
discuss both strengths and weaknesses. With rare exceptions, no
single study on its own, is able to definitively arrive at a
conclusion. You add to the weight of the evidence on a
particular issue.
Mrs. Morella. It is our understanding that the Vaccine
Safety Datalink Project was your idea, your concept. Is that
true?
Dr. Chen. I don't know if it is unique. I think there were
several other predecessors who actually did smaller projects,
versions of these large linked data bases. In fact, the drug
safety folks actually came up with early versions of these
linking up automated pharmacy files with automated outcome
files. In science, we are always building on others ideas.
Mrs. Morella. You are being pretty modest about it. Was the
project originally designed for a specific length of time or
was it designed to go into perpetuity?
Dr. Chen. I think the thought was that be we will continue
to vaccinate and presumably there will continue to be vaccine
safety issues. Our initial contract I think was for 5 years
because that is how long government contracts could be, so I
don't know if we actually thought in terms of how long it would
run but definitely would run for 5 years.
Mrs. Morella. Five years I think was the original intent.
Why was the project extended past the original 5 year plan?
Who made the decision?
Dr. Chen. I think the main reason is there continued to be
new vaccines added to the schedule and there continued to be
new vaccine safety issues that arose. The main impetus in early
1990 when we got started was the Institute of Medicine review
of the evidence available on the safety issues as part of the
Vaccine Injury Compensation Act. About two-thirds of the issues
they looked at, they had to take the agnostic position that
there was inadequate evidence to accept or reject a causal
relationship, so there was a large number of research issues
that were backlogged from before.
Mrs. Morella. But who made the decision? Who at CDC
determines what studies will be conducted?
Dr. Chen. It is a decision like any multicenter research
project. It is done collaboratively through the principal
investigators, so we have a monthly conference call among the
PIs to look at potential new study ideas. We take into account
a variety of potential study ideas, be it from the Institure of
Medicine, be it from VAERS, be it from case reports and the
literature, and then, in an annual face to face meeting, we try
to further prioritize among our ongoing studies.
Mrs. Morella. So it is collaborative?
Dr. Chen. It is very much an unusual partnership. It is the
largest collaborative project between CDC and managed care
organizations. We have the public health interest to do the
vaccine safety monitoring. This is perhaps one aspect that is
different for us compared to Canada and Saskatchewan where
there is national health insurance. The HMOs have their own
internal administrative data bases as part of their regular
internal private insurance organization. So we piggy-backed the
VSD project onto data that is collected for routine medical
care in the HMO's.
Mrs. Morella. In February of this year, I understand you
and other CDC employees met with committee staff to discuss the
release of the Vaccine Safety Datalink raw data to researchers?
Dr. Chen. It was not the raw data. I think there is some
confusion. We had talked about access in terms of the completed
VSD studies. If individuals wished to do independent validation
of our findings, we would make that available through the
Research Data Center.
Mrs. Morella. At this meeting, CDC provided a draft
proposal for researchers to access the VSD data. I understand
the staff was told the project was ready to go. Is this project
now up and running?
Dr. Chen. I think someone contacted me yesterday in terms
of the proposal process and we are in discussions with them.
Mrs. Morella. I understand no one has seen a press release?
Have you done a press release or an advertisement in any of the
medical journals or on the CDC Web site?
Dr. Chen. Generally we do not publicize or issue a press
release in matters like this. That is handled by the
Department. We pursued this issue with the urging of the
committee and made your staff aware of the availability of this
new policy so that, if other researchers wish to replicate the
findings, we would make it available.
Mrs. Morella. You can see what I am getting at, the idea
that I think it is important that you make the announcement.
Otherwise, how do you propose that people are going to know the
program exists.
The committee was sent an email message last week saying
applicants could send their applications to you? Do you have
the procedures and the timeline for people to respond?
Dr. Chen. As I mentioned earlier in response to a question,
this is a pilot process we are working out and we want to
accept those requests and just work it through and see how it
goes. I think this is very much an experiment in terms of
seeing whether, in fact, we are able to maintain this very
valuable infrastructure for vaccine safety monitoring to the
extent that the HMOs are still willing to continue to
participate. We cannot mandate them to participate. It is
really their patients, their data base and their institutional
review boards who have oversight over the access to these data.
Mrs. Morella. Can outside researchers contact the HMOs who
participate in the VSD directly with specific research
proposals?
Dr. Chen. If they wish, sure. Currently, the infrastructure
the VSD has built has permitted a number of other folks
interested in research, folks interested in doing vaccine
related research, to work directly with the HMOs, yes.
Mrs. Morella. My name has expired. I would yield back.
Thank you for your response. You can see we are looking at what
that streamlined procedure will be, the openness timeline.
Mr. Burton. We certainly want to see this opened as quickly
as possible so that other researchers can check on all these
things we are talking about.
Dr. Egan, one thing has bothered me for a long, long time.
Do you know when thimerosal was checked for its safety
initially?
Dr. Egan. The first study that I am aware of I guess was in
the late 1920's when some researchers from Eli Lilly first
evaluated.
Mr. Burton. Do you know of any safety studies after that
one or is that the only one?
Dr. Egan. That is probably the only direct.
Mr. Burton. Do you know anything about the study? Have you
ever looked at that study?
Dr. Egan. Yes, the original publication of it. Yes.
Mr. Burton. Do you know that everybody, from what I have
been told, everybody in that study was suffering from some kind
of meningitis and it was a fatal disease, and that every one of
them died, so there was no way to know if the thimerosal was
safe or not because every one of the people injected with it
died. They died from the Meningitis. Did you know that?
Dr. Egan. No I have to go back and look at that.
Mr. Burton. You mean to tell me that since 1929, we have
been using thimerosal and the only test you know of is the one
done in 1929 and everyone of those people had meningitis and
they all died?
Dr. Egan. There are other reports about the use of
thimerosal in various products.
Mr. Burton. Yes and they took methiolate off the market.
Dr. Egan. Yes, as a topical.
Mr. Burton. But you don't know of any other study, thorough
study, that showed the safety of thimerosal?
Dr. Egan. No, other than those studies that were done using
it in end products and at whatever doses they had where they
did see some safety related issues.
Mr. Burton. The point is before you put a product on the
market, before you start using it and injecting it in children
or putting it in the products that people can put on their skin
that might be toxic, shouldn't there be a very thorough test to
make sure it is safe?
Dr. Egan. The product itself, the final formulation of the
vaccine, is studied and these studies were done. The limitation
of those studies is that they would only find the more acute,
the more rapid adverse events that might occur.
Mr. Burton. But you are not familiar with any study that
specifically deals with thimerosal?
Dr. Egan. There were animal based studies but not in humans
other than those studies where it was in products where either
people received too much by accident or what else and they
could get ideas of what the toxic doses were and then the other
studies that are environmental trying to get estimates of the
toxicity of mercury.
Mr. Burton. So the way you found if there was too much
thimerosal given was from the person who got the shot? So they
were guinea pigs because you really didn't know how much
thimerosal was going to be tolerable in a human being?
Dr. Egan. These weren't studies that were done directly
like that.
Mr. Burton. How did you know how much thimerosal could be
put into a vaccine or a product?
Dr. Egan. They started off with the amounts of thimerosal
that were needed as preservatives. There were animal-based
tests. The amounts were certainly much, much less than the
amounts that gave out of those Lilly studies and then during
the investigational drug phase, adverse events were monitored
and none were seen.
Mr. Burton. You testified before this committee on July 18,
2000 that the FDA's major concern regarding thimerosal in
vaccines started around May 1999. That is on page 282 of the
mercury hearing transcript. We would like you to see this FDA
email sent by Dr. Peter Patriarca, a CBER employee, to Roger
Bernier and Jose Cordero regarding an FDA plan in place for
many years to remove thimerosal from vaccines. It is exhibit
No. 15. Do you have that before you, sir? Can you take a look
at exhibit No. 15? Dr. Chen, can you give him exhibit No. 15,
please?
Let me read directly from exhibit No. 15. It says, in the
email I just referred to, ``The fact of the matter is that an
interim plan for potential removal of thimerosal has already
been in place for many years. We just need to speed up the
existing plan, not create a new interim plan. We are proactive,
not reactive. Thanks, Peter, P.'' Why wasn't thimerosal taken
out of all these vaccinations, if the plan had been in place
for many years according to this email, and why didn't this
committee get a copy of the interim plan?
[Exhibit 15 follows:]
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Dr. Egan. I am not aware of any interim plan.
Mr. Burton. What is he talking about?
Dr. Egan. I am not sure what he is talking about. There was
probably some discussion.
Mr. Burton. Have you read that? It says again, ``The fact
of the matter is that an interim plan for potential plan for
removal of thimerosal has already been in place for many
years.'' They already had an interim plan and you are not aware
of that?
Dr. Egan. No.
Mr. Burton. Then it goes on to say, ``We just need to speed
up the existing plan.'' So there was a plan to get this mercury
product out of vaccines for many years but you don't know about
it?
Dr. Egan. No. I know there had been some discussions with
some of the manufacturers as they were developing vaccines to
caution them not to add additional thimerosal.
Mr. Burton. Why wouldn't you want to add additional
thimerosal?
Dr. Egan. Not to add additional thimerosal or to add
thimerosal as a preservative if it could be avoided.
Mr. Burton. I think anyone paying attention to this
discussion probably gets the strong impression that the
scientific community and our health agencies knew that the
mercury was a dangerous thing to have in those vaccines and yet
for some reason, even though it had been discussed time and
again to remove it from these vaccines, they kept putting it in
there. The only conclusion that I can come to is it was money,
there was some kind of money involved. This a product produced
by big pharmaceutical companies and used by pharmaceutical
companies and to expeditiously take it off the market was going
to cost them a lot of money and that brings us to the possible
conclusion that there is undue influence being exerted on our
health agencies by the pharmaceutical industry. What do you
think about that?
Dr. Egan. From my own experience, I would say no, that
wasn't the case.
Mr. Burton. Then why is thimerosal still in there? If this
was an interim plan that had been discussed years before, why
wasn't it taken out?
Dr. Egan. As I said, I am not aware of this interim plan
that was existing that Dr. Patriarca is referring to. I can
only speak to my own personal involvement in this. In the late
1990's, I guess in 1999 around the summer when the issue arose,
and did work with the vaccine manufacturers to remove and
reduce thimerosal from their products.
Mr. Burton. I know, because we have been raising so much
cane about it and there is a lot of heat being generated. This
email was to you, Dr. Bernier, wasn't it?
Dr. Bernier. I don't specifically recall the email but if I
can look at the exhibit?
Mr. Burton. Sure, go ahead.
It is to RHB2. Is that your email address?
Dr. Bernier. Yes, Mr. Chairman.
Mr. Burton. You don't recall getting that?
Dr. Bernier. I think looking at the date, this is late June
1999, in the early days when we were pulling together the first
joint statement on thimerosal. It looks like we were exchanging
views about the pros and cons of moving forward with that joint
policy statement. It looks like Dr. Patriarca was commenting on
some of the pros and cons of moving forward in the direction we
were moving. So, yes, I did get this email.
Mr. Burton. On July 2, 1999, Dr. Robert Plesse sent Dr. Ben
Schwartz, then of the NIP Office, an email regarding thimerosal
and the drafting of answers to possible questions that would
arise from the release of a statement. In this message it
states, ``You mean the FDA does not already know? How could
they approve a product without knowing how much mercury it
contains? What else is lurking that nobody knows about? That is
exhibit No. 13. Are you familiar with that email? This is from
Dr. Plesse of the FDA and it is to Ben Schwartz, the Acting
Commissioner. Are you familiar with that?
[Exhibit 13 follows:]
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Dr. Egan. I haven't seen this but we certainly did know the
amount of thimerosal that was in each vaccine, so I don't know
what this means. FDA did already know and the amount of mercury
that is in every product is published in the package insert.
Mr. Burton. Who is Dr. Plesse? Do you know who Dr. Plesse
is?
Dr. Egan. He worked for the Bureau of Biologics in Canada
and he currently works for the Centers for Disease Control.
Mr. Burton. And he is the one that sent this. ``You mean
the FDA does not already know'' and you say they did know?
Dr. Egan. But we do know.
Mr. Burton. Did you know then?
Dr. Egan. Yes. The amount of mercury that is in each
product is in the accompanying package insert. So we know it,
and it is publicly available.
Mr. Burton. Dr. Plesse also made the statement, ``It is
also no longer going to wash that there is no data to suggest a
risk.'' Did anybody see that memo? Any of you? This was in 1999
and it says, this is also no longer going to wash that ``there
is no data to suggest a risk.'' That is 3 years ago. Three
years ago a memo was sent saying it is not going to wash. It
ain't going to wash that you don't know that there is a risk
there and you continue to have thimerosal in the vaccines. When
I asked at previous hearing like this one, I said why don't you
just recall everything with thimerosal in it right now and put
out there single doses of measles vaccine or whatever which
doesn't contain this possible toxic substance and get it over
with. Nobody had an answer.
The only answer I could figure out was that there was money
involved. The pharmaceutical companies were going to lose some
money if you pulled this stuff off the market. Is that
assumption incorrect?
Dr. Egan. I would disagree with it.
Mr. Burton. What do you think about what this doctor said?
Dr. Egan. I am not sure exactly what he is referring to.
This was around the time that people were saying, yes, there is
no data that suggests there is a risk. In other words, there is
no positive data showing any risk, whether or not it is
sufficient to just say that or whether one has to go out and
generate data to show there is no risk or one is going to have
to do something else.
Mr. Burton. Here is the crux of the problem. If there is a
risk when you are injecting something into a child, shouldn't
we err on the side of caution and if you get a memo, an email
that says, it is not going to wash, that there is no risk. If I
were in an agency and I knew there was going to be a risk to
human beings, I would say, we have to get on with this right
away. We have to get this stuff taken care of.
Dr. Egan. Again, I am not sure what he meant by that
statement. I haven't had a chance to discuss it with him. This
wasn't sent to me.
Mr. Burton. Let us read it again. ``It is also no longer
going to wash that there is no data to suggest a risk.'' It
doesn't take a rocket scientist to understand that.
Dr. Egan. I don't know whether he meant that what we have
to do is go out and do studies to positively demonstrate that
there is no risk or that there is a risk rather than just
simply say that there is no evidence saying there is no risk.
That may not be good enough.
Mr. Burton. Do you think injecting mercury into a human
being poses any kind of risk whatsoever?
Dr. Egan. At the doses that were used, that have been used
in the vaccines, no, there was no evidence that was posing a
risk.
Mr. Burton. Does mercury being injected into a human being
have a cumulative effective? In other words, if you get eight
or nine shots of mercury, would it have a cumulative effect in
your brain?
Dr. Egan. There may be some effect. That has to be looked
at, finding out the rates of excretion versus the rates of
deposition into various tissues and what those rates of
clearance are. One thing I would like to stress is that as this
issue came to the fore, the Public Health Service and the FDA
did state that they wanted to reduce levels of mercury from all
sources whenever possible and we did very, very actively work
with manufacturers to eliminate and reduce mercury from all the
routinely recommended pediatric vaccines. It was not a very
simple and straightforward process doing that.
Mr. Burton. Let me just say that according to ``experts''
my grandson got nine shots in 1 day that contained about 40 or
45 times the amount of mercury tolerable in an adult in 1 day
and within just a few days, he became autistic. I imagine a lot
of people in the audience and people around the country dealing
with this sort of problem right now feel the same way. To have
our health agencies continue with this on what appears to be
the back burner really bothers me.
Let me ask a couple more questions of Dr. Chen. Have you
received any requests to date for the data?
Dr. Chen. On Monday, when I came back from some travel,
there was a voice mail from one of the consumer groups on
autism who asked us to work with them to make the data
available.
Mr. Burton. So you have only had one so far. Do you recall
the name of the organization?
Dr. Chen. I think it was Elizabeth Birt but I don't
remember the agency she represents.
Mr. Burton. At this time, no one outside the CDC or HMOs
has had access to the VSD data so far, right?
Dr. Chen. In terms of this new research data center, that
is correct.
Mr. Burton. You attended a staff briefing in late February
with the committee which we have established. At the end of the
meeting, the Secretary's representative informed the committee
staff that prior to the committee request, about 18 months ago,
no one had ever suggested to the CDC that the VSD data should
be made available. Is that true?
Dr. Chen. I don't know if that is true or not. Obviously
people out there can say things without me being knowledgeable.
Mr. Burton. You don't know of any at all?
Dr. Chen. I don't know at this point, no. I don't recall,
at least.
Mr. Burton. The Office of the Secretary not having been a
part of this program since its inception had to rely on you and
your staff for their briefing, didn't they?
Dr. Chen. I presume so.
Mr. Burton. Do you agree with the statement that prior to
our committee's request to make the VSD data available, that no
one had made such a suggestion?
Dr. Chen. Being a human being, to my best recall, that is
the case.
Mr. Burton. Can you give me a yes or no answer? Did anybody
or any organization or scientist request this data from you
prior to that?
Dr. Chen. To the best of recall, I don't remember anyone
making that request.
Mr. Burton. When I was having my investigation in the
previous administration, we had what we called an epidemic of
memory loss and the reason that epidemic of memory loss
occurred was because people were afraid they would be nailed
for perjury. That is not the case with you, I hope.
Dr. Chen. I hope not.
Mr. Burton. Isn't it true that as early as 1993, the CDC
was getting requests to make the VSD available to other
researchers? Take a look at exhibit No. 3, the bottom of page
6, top of page 7. You are the guy in charge of this and this is
1993. You just said you didn't recall whether there had been
any request. Here we are going back to 1993. Would you take a
look at that, at the bottom of page 6, top of page 7. I will
read the quote to you. In the meeting minutes from a CDC-
sponsored meeting that took place on January 12, 1993, the
large linked data managers meeting, a part of the VSD annual
meetings, here is the reference, ``Guidelines to using the LLDB
files, data managers indicated that a growing number of people
are expressing interest in using LLDB files for specific
vaccine safety and other types of studies. Because the files
are so complex, it is important to develop written guidelines,
write model programs and provide SAS and/or consultation for
other uses in order to insure the files are used correctly.
This may become very resource intensive, especially as the
datasets grow and LLDB results are presented.''
Doesn't this mean then that almost from the beginning, the
CDC was being prompted to allow access to the data base?
[Exhibit 3 follows:]
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Dr. Chen. This is a meeting back from January 12, 1993
among data managers and I was not present at that data managers
meeting.
Mr. Burton. So you weren't aware of any of this?
Dr. Chen. I was not aware of this discussion, no, because I
was not present.
Mr. Burton. Would you not have received these minutes of
this meeting?
Dr. Chen. I may have received it but as most of us know, we
don't always read every single word of the meetings we were not
at, so I don't recall reading this.
Mr. Burton. This is pretty important stuff. We are talking
about release of some of this data so that other research
scientists can go out and look into this stuff. You got this
memo and didn't even read it?
Dr. Chen. It looks like it is about 10-15 pages of very
detailed discussion about different aspects of data management
and I don't recall having read this one.
Mr. Burton. Why do they even have these meetings and give
you the minutes if you are in charge of this if nobody is going
to do anything with it? Here it says, ``Data managers indicated
that a growing number of people are expressing interest in
using LLDB files for specific vaccine safety and other types of
studies.'' That is pretty important. Outside groups wanted to
start doing this 9 years ago and you didn't know about it?
Dr. Chen. As I mentioned, in all the discussions with the
HMOs, their major concern was the protection of the privacy of
their patients.
Mr. Burton. That is not the point. You said you didn't know
there was a request. Did you know there was a request for this
or not?
Dr. Chen. Again, I was unaware of this discussion.
Mr. Burton. How about anytime since then in the last 9
years, were you aware that outside groups wanted this
information?
Dr. Chen. Until the recent discussion from a couple of
years ago, no one has really approached us.
Mr. Burton. In the last 2 years, are you aware of anybody
asking for this information?
Dr. Chen. There has been some Freedom of Information Act
requests.
Mr. Burton. So you did get some requests from outside
groups in the last couple of years?
Dr. Chen. Yes, that is correct.
Mr. Burton. So you remember that.
Did you have something you wanted to say, Dr. Bernier?
Dr. Bernier. I just wanted to suggest to Dr. Chen that he
might want to talk a little bit about some of the
collaborations that have occurred over the years. I don't want
to leave the impression that this was a totally closed system.
There are others who have made use of the system. Dr. Chen is
in a much better position than I am to say that. There may not
have been requests coming in under the Freedom of Information
Act but again, I think the question was asked earlier this
morning, can people collaborate with the HMOs and yes, it is my
understanding, and again, let Dr. Chen comment, but the HMOs
are open to collaboration if people want to approach them.
Mr. Burton. One of the things Dr. Weldon stressed was that
credibility is extremely important. People have to trust their
government. If they don't, you have a real mess on your hands.
We currently have problems with some people who don't trust the
FBI, they don't trust the CIA, they don't trust other agencies.
One of the agencies they really should have to trust and be
able to trust is the people who are prescribing needles being
stuck into their kids' arms for vaccinations.
You talk about you having closed study just inside the CDC
or HHS and doing a collaborative study with somebody else you
might be able to control. What we are talking about is giving
the information to scientists on the outside who can verify and
make absolutely sure that the information is correct, that the
vaccines are safe, that there is no problem with things like
thimerosal. That is why these independent studies are
important.
It appears as though there has been a circling of the
wagons as Dr. Weldon said to keep everybody else out. That has
to change if there is going to be a belief that our health
agencies are shooting straight with the American people.
Dr. Chen, isn't it true that Dr. Harold Guess, an employee
of Merck, who has been invited repeatedly into the VSD planning
meetings, also suggested to you in 1995 that CDC needed to make
the data available to outside researchers such as industry
researchers? Did Guess, an employee of Merck, say that to you
in 1995?
Dr. Chen. He is also a professor at the University of North
Carolina in terms of his status. I think in terms of
discussion, that is a sensitive issue that the HMOs had. We
have worked with them and I think we now have a research data
center process to work that out.
Mr. Burton. That isn't the question. You said, first, you
don't remember anybody asking for this data. First you said you
didn't remember. Then you said, yeah, there was a couple of
years ago some people talked to me, so you got that far. Now we
are going back to 1995. Dr. Harold Guess, an employee of Merck
who has been invited repeatedly into VSD meetings, also
suggested to you in 1995, 7 years ago, that CDC needed to make
this data available. Do you recall that?
Dr. Chen. I must admit I don't recall that.
Mr. Burton. You don't recall that.
Dr. Chen, please go to exhibit No. 10, January 1995. It is
the annual VSD meetings. I would like you to turn to page 4 of
the section titled ``Priorities.'' Do you see that?
[Exhibit 10 follows:]
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Dr. Chen. OK.
Mr. Burton. Would you read to the committee the two
sentences beginning with ``There was consensus?'' ``There was
consensus that nothing `focuses the mind like writing a paper'
``and the highest priority for the project was in publishing
the results of the studies, thereby garnering visibility and
hopefully continued support and funding. Is this taxpayer
funded project simply to keep a bunch of scientists employed
and to pad your curriculum vitae with publications or is it to
actively look for adverse events related to vaccines and to
protect our children?''
Dr. Chen. Well, it is both. You hope to be able to do
vaccine safety monitoring but that those results need to be
shared with the public in peer review research and as part of
the scientific process. Hopefully, by demonstrating that
productivity, you are also able to continue to get additional
resources.
Mr. Burton. Let me ask one or two more questions and we
will call it a day. It has been a long day.
Dr. Bernier, as you know, there has been a great deal of
concern about the changing of the definition of encephalopathy
in the vaccine injury compensation program. This change
resulted in many cases being ruled ``off table'' and thus
harder to be compensated. We have repeatedly been told that the
Department adopted an existing scientific definition. I am
going to read to you verbatim from January 12, 1994 a VSD
annual meeting summary written and approved by CDC employees.
``Encephalopathy, the definition developed by Jerry Finecel
for revision of the Vaccine Injury Table and published in the
Federal Register should be adapted.'' Dr. Bernier, it appears
that Congress and the public have been misled about this
definition. I am going to ask that you take back to the
Secretary a request to revert to Congress' definition
immediately. Do you have exhibit No. 5, page 2, paragraph 6.
[Exhibit 5 follows:]
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Dr. Bernier. I don't know if this is the appropriate time
or if you want to finish this but I would like to recommend or
suggest that we defer questions about the compensation program
to representatives from HRSA. There is not a HRSA
representative here today and we were asked if any questions
did come up, could we ask for them to be sent to HRSA so they
could respond for the record.
Mr. Burton. I think the Secretary should be made aware of
the definition that is currently being used. It should be
changed. I will be glad to send a memo to him as well but I
would like you to go back and ask him to review that along with
you to see if that is in order.
Dr. Bernier. We would be happy to do that.
Mr. Burton. We will prepare a memo to that effect.
We have some more questions I would like to submit for the
record but I am tired and I am sure that you are tired and we
don't want to keep beating on this ad infinitum.
Dr. DeStefano, you worked with Dr. Verstraten on the
thimerosal study, didn't you?
Dr. DeStefano. Yes.
Mr. Burton. Would you turn to exhibit No. 14 and read the
results in the conclusions section, please?
[Exhibit 14 follows:]
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Dr. DeStefano. ``Results, we identified 3,517 children with
neurologic disorders and 106 with renal disorders. We found a
statistically significant positive correlation between the
following measures of exposures and outcomes, cumulative
exposure at 2 months of age and unspecified developmental
delay, cumulative exposure at 3 months of age at TICS, a
cumulative exposure at 6 months of age in attention deficit
disorder, a cumulative exposure at 1, 3 and 6 months of age in
language and speech delay, a cumulative exposure at 1, 3 and 6
months of age in neurodevelopmental delays in general.
Conclusion, this analysis suggests that in our study
population, the risk of TICS, ADD, language and speech delays
and developmental delays in general may be increased by
exposures to mercury from thimerosal containing vaccines during
the first 6 months of life, confirmation of these findings in a
different population and further quantification of the dose
response effect are needed.''
Mr. Burton. Do you recall the date of that? We don't have
the date.
Dr. DeStefano. It must have been like probably winter,
later winter, early spring of 2000.
Mr. Burton. Has that study been published?
Dr. DeStefano. This was presented, I believe, at the
Epidemic Intelligence Service Conference in April of that year.
Mr. Burton. Was it published?
Dr. DeStefano. No, those are not published proceedings.
Mr. Burton. They are not.
Dr. DeStefano. This was a training program and this is
usually the conference where the Epidemic Intelligence Service
officers in training present their research but they are not
published.
Mr. Burton. It showed there was a problem, didn't it?
Dr. DeStefano. This is the analysis that the autism figures
come from that was displayed earlier.
Mr. Burton. What was Dr. Verstraten's role at the CDC when
the study was conducted?
Dr. DeStefano. He was an Epidemic Intelligence Service
officer, so he was there to obtain training in applied
epidemiology.
Mr. Burton. He is no longer with the CDC, correct?
Dr. DeStefano. No, he is not.
Mr. Burton. Isn't it true that shortly after the study Dr.
Verstraten left the CDC and took a job with a vaccine
manufacturer?
Dr. DeStefano. Yes.
Mr. Burton. In June 2000, the VSD project held a meeting,
Exhibit No. 16. Could you look at exhibit No. 16? In June 2000,
VSD project held a meeting at the Simpson Wood Retreat Center,
correct?
Dr. DeStefano. Yes.
Mr. Burton. Would you explain the purpose of that meeting?
Dr. DeStefano. I could explain but Dr. Bernier organized it
and he would be better able to explain.
Mr. Burton. It was to discuss the thimerosal study, was it
not?
Dr. DeStefano. Right.
Mr. Burton. Was that correct?
Dr. Bernier. That is correct.
Mr. Burton. As you can see, exhibit No. 16 is an internal
memo from Dr. Harold Guess at Merck to Merck employees
distributing the thimerosal information from the Simpsonwood
meeting. Isn't it correct that all the vaccine manufacturers
had representatives at that meeting?
[Exhibit 16 follows:]
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Dr. Bernier. I can't say that all of them did but they were
invited.
Mr. Burton. But most of them were there?
Dr. Bernier. I believe that is correct.
Mr. Burton. What were the industry's recommendations or
concerns about the study? We are going to find out so I hope
you will give us the whole story here. What was the industry's
concerns about that study?
Dr. Bernier. I am not sure that I can characterize
industry's concerns separate from the concerns of
epidemiologists or other members of the group that were there.
We didn't segregate out peoples' views by their affiliations.
Mr. Burton. So the views of CDC or FDA or the health
agencies would be incorporated in with the pharmaceutical
representatives that were there?
Dr. Bernier. No. The pharmaceutical representatives were
not there as consultants. The Simpson Wood meeting was called
together on short notice by CDC because these results had
caused concern on our part and we wanted to consult with expert
opinion outside the agency. As a result, we invited somewhere
in the neighborhood of 12 or 15 individuals.
Mr. Burton. Where were they all from?
Dr. Bernier. They came from academia, they came from I am
not exactly sure. We did it more by expertise. We were looking
for pediatricians, neurologists, epidemiologists, that kind of
thing.
Mr. Burton. Were most of them from the pharmaceutical
companies?
Dr. Bernier. Oh, no. They were just a minority. The members
from the vaccine companies were not there as consultants. They
were there as observers because their products were the subject
of the conversation, so CDC felt it was appropriate for them to
be aware of these data so they could have an opportunity to
assess them along with others who were looking at them.
Mr. Burton. Did any of the industry representatives make
any recommendations or anything while they were there? Did they
say we have a problem with this report?
Dr. Bernier. It is difficult to deal with things on two
sides. They were free to talk. If they were at the meeting,
they were observers in the sense that they were not the
consultants per se but if they had an opinion about the data or
about anything going on, I am sure the chairman of the group
would have recognized them and would have allowed them to
express their views.
Mr. Burton. Were there minutes taken at the meeting?
Dr. Bernier. Yes, there were. I don't know about minutes
but I believe there is a transcript and report that was
written.
Mr. Burton. I would like to have that transcript, post
haste and if need be, I will give you a subpoena for it. I want
a transcript of that, I want to read it. I want to find out if
the pharmaceutical industry had any influence over the
decisionmaking process of our health agencies because if that
is the case, there is going to be a big, big problem. How soon
can I have that transcript?
Dr. Bernier. I believe the transcript is available. It
should not take a long time. I would think a matter of days if
we can put our hands on it.
Mr. Burton. I sure hope you can put your hands on it.
Dr. Bernier. That shouldn't be a problem, Mr. Chairman.
Mr. Burton. Why haven't you submitted that information I
read to you a few minutes ago, Dr. DeStefano, for peer review?
Dr. DeStefano. That is part of the manuscript that was
developed from this. I think its current status perhaps Dr.
Chen could talk about. I am no longer involved.
Mr. Burton. Dr. Chen.
Dr. Chen. Unusual to most scientific studies, in fact
because of the importance of this study, the analyses of the
VSD have been shared publicly in multiple forums, at
Simpsonwood, at the ACIP, and at the IOM. At each of the
meetings, several interested parties on both sides of the
equation have raised many concerns about how they want the
study improved or analyzed and we have been trying to address
those concerns. We have finished that and we expect to submit
the paper for peer review shortly.
Mr. Burton. I think I will let you fellows go for the time
being. I am sure we will be together again before long. I
appreciate your being here.
If you are still here, can I have the first panel come back
to the table, I have a few more questions. I really don't have
any questions, I just want each of you, as people who have
worked on this subject a long time, I would like to have any of
your thoughts on what you just heard regarding all this
questioning. We are talking about kids who have been harmed, so
if you have any comments you would like to make, I would like
to hear them for the record. If you don't, that is fine as
well.
Dr. Bradstreet. As a parent of a child with autism, as a
physician, it would have been wonderful, absolutely grand to
have the information that has been kept largely behind closed
doors for years available to me both as a parent and as a
physician to guide my decisionmaking about vaccine
administration.
Mr. Burton. Amen.
Dr. Bradstreet. I think it is appalling that some of their
answers were clearly evasive and fly in the face of reality--
where we just received evidence that in fact there was abundant
information that thimerosal associated itself with a variety of
different problems, all of which for the most part would be
associated with neurodevelopmental disorders typical of autism
with speech language delay, general overall neurodevelopmental
disorders.
To then take that data and say there is no relationship to
autism where most of those constituents are part of the
spectrum of autism, seems hypothetically almost impossible and
statistically almost impossible. I think we have been done a
disservice in the way in which this data has been withheld for
2, 3, 4 years. I think it has and should have been the cause of
a recall of thimerosal immediately. I think we have seen some
of the issues they were concerned about: whether or not we
would continue to have the uptake of vaccines, if the parents
would continue to submit to voluntary vaccination programs, and
I realize some of the driving forces behind that.
The problem is in the process of attempting to cover this
up they haven't done a very good job. Parents have found out
the truth. They have multiple access, whether it is through
Freedom of Information or through various other resources, to
find out the toxicology of mercury and find out the problems
with persistent viral infections.
I think it is incredibly valuable for this committee to
continue its work trying to expose the truth. I thank you very
much for it.
Mr. Burton. You don't have any doubt about that do you?
Dr. Bradstreet. No, I don't.
Mr. Burton. There are a lot of reasons I am concerned about
the health and safety of the entire population of America but I
am so ticked off about my grandson and my granddaughter just
like you are that I can't see and to find that our health
agencies have, as Dr. Weldon said, circled the wagons trying to
keep us from knowing the facts just makes me want to vomit.
Dr. Bradstreet. Do you think it is any coincidence that the
rise and the use of ritalin, which I think various other
government agencies have had hearings on the use of ritalin,
absolutely corresponds to the rise in the use of mercury and
that they find a statistically significant increase in ADHD?
Mr. Burton. Those are things that we will continue to beat
on and try to get to the bottom of with your help and others.
Anybody else have any comments?
Dr. Wakefield. One comment and that is my third occasion
here. It underscores for me the overwhelming need to
disassociate those who mandate and endorse vaccines from those
who monitor safety. You cannot referee your own soccer matches.
It is like asking an Italian referee to take over the game of
Italy between South Korea. It doesn't work, can't do it. You
have to separate those agencies that endorse and mandate
vaccines and those who monitor safety. One needs to be on the
back of the other all the time in order to check on safety.
It also underscores the value of your Freedom of
Information Act which we do not have in the United Kingdom. It
is enormously to this committee's credit that it has gotten as
far as it has. The work clearly must continue.
Mr. Burton. Al Jolson used to sing and they would bring the
curtain down and the audience would be up pounding the floor
and clapping because he was such a great entertainer. He would
get down on one knee and say, you ain't seen nothing yet. Other
comments? Dr. Spitzer.
Dr. Spitzer. I would like to say as a Canadian
epidemiologist I am also a member of the Institute of Medicine
of the USA, that if one had to make a choice between
epidemiology and the clinical and laboratory disciplines
looking at all of this, one sets epidemiology aside and one
goes to the clinic, one goes to the labs and some of the work
that has been done in Britain and here and we have heard about
today.
Nevertheless, having said that, I would urge thoughtful,
responsible colleagues such as those in the committee and
leadership in this country and elsewhere, that we need to push
the answers in parallel, in three or four areas, the biological
mechanisms such as have been done by Dr. Friedman and Professor
O'Leary; the epidemiology which so far has been
noncontributory, the Institute of Medicine says there is no
evidence and that is very different than saying the evidence
demonstrates there is no relationship. You can see the itty
bitty study we saw today and that is the kind of epidemiology
that we find when we go and look plus others and we really need
to do serious work.
We were talking about sample size. The study we designed
internationally to get some answers has 3,500 cases and 7,000
controls. Why? Suppose 10 percent of the children are affected
by one product, say MMR, that subset also has to be
statistically significant or we are going to have to use
another 5 years. I will make that my own example.
I want to thank you as one who benefits from the fact I
have no family members involved or anything that the support by
this committee and its staff to those trying to look at this
seriously in various country and I think this hearing was
extremely important to many of us involved.
Mr. Burton. Ladies first, Dr. Krigsman.
Dr. Stejskal. You have an admirer in Sweden for your work
with this issue of chemical toxicity. As an immunologist
working for a long time in pharmaceutical industry at
toxicology laboratory, I am still shocked regarding risk
benefit assessment of this additive thimerosal. I don't see the
reason why it wasn't changed and replaced by other additives
like, for example, chloride. For me this is astonishing and
shocking. I think your explanation of money is the right one.
I also hope you will continue with your work to remove all
mercury from the body and out of the fillings. I want to tell
you that in Europe, the nickel is already banished and
prohibited as a part of metal alloys used in dentistry while
unfortunately here in America, you still have high nickel rich
metal alloys allowed. Nickel is another mutagen and carcinogen
and so on.
We will help you in any way we can. I hope you will go on
with your work.
Mr. Burton. Thank you.
Dr. Krigsman.
Dr. Krigsman. I would like to conclude by saying what has
happened in the past and what this committee is interested in
looking into is one issue. I want to project to the future and
I would invite the governmental agencies to show and
demonstrate their commitment to research in this area by
providing funding for those people who are pursuing those
answers. Thank you.
Mr. Burton. Thank you very much. I want to thank all of you
for being so patient. You have been here since 10 a.m. I really
appreciate that. You are doing the good Lord's work. Hopefully
there will be a lot of children and people that will grow up a
bit safer because you are willing to come and testify.
Dr. Wakefield, hang in there, buddy.
Thank you.
[Whereupon, at 2:40 p.m., the committee was adjourned, to
reconvene at the call of the Chair.]
[The prepared statements of Hon. Constance A. Morella, Hon.
Edolphus Towns, Hon. Dennis J. Kucinich, additional information
submitted for the record, and the complete set of exhibits
follow:]
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