[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






                       U. S. GOVERNMENT PRINTING OFFICE
82-358                          WASHINGTON : 2002
___________________________________________________________________________
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                     COMMITTEE ON GOVERNMENT REFORM

                     DAN BURTON, Indiana, Chairman
BENJAMIN A. GILMAN, New York         HENRY A. WAXMAN, California
CONSTANCE A. MORELLA, Maryland       TOM LANTOS, California
CHRISTOPHER SHAYS, Connecticut       MAJOR R. OWENS, New York
ILEANA ROS-LEHTINEN, Florida         EDOLPHUS TOWNS, New York
JOHN M. McHUGH, New York             PAUL E. KANJORSKI, Pennsylvania
STEPHEN HORN, California             PATSY T. MINK, Hawaii
JOHN L. MICA, Florida                CAROLYN B. MALONEY, New York
THOMAS M. DAVIS, Virginia            ELEANOR HOLMES NORTON, Washington, 
MARK E. SOUDER, Indiana                  DC
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

                              ----------                              


                        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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