```

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

 
         MERCURY IN MEDICINE--ARE WE TAKING UNNECESSARY RISKS?

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

                                HEARING

                               before the

                              COMMITTEE ON
                           GOVERNMENT REFORM

                        HOUSE OF REPRESENTATIVES

                       ONE HUNDRED SIXTH CONGRESS

                             SECOND SESSION

                               __________

                             JULY 18, 2000

                               __________

                           Serial No. 106-232

                               __________

       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

_______________________________________________________________________
 For sale by the Superintendent of Documents, U.S. Government Printing 
                                 Office

Internet: bookstore.gpo.gov  Phone: (202) 512-1800  Fax: (202) 512-2250
               Mail: Stop SSOP, Washington, DC 20402-0001

72-722

                                 ______

         MERCURY IN MEDICINE--ARE WE TAKING UNNECESSARY RISKS?

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

                                HEARING

                               before the

                              COMMITTEE ON
                           GOVERNMENT REFORM

                        HOUSE OF REPRESENTATIVES

                       ONE HUNDRED SIXTH CONGRESS

                             SECOND SESSION

                               __________

                             JULY 18, 2000

                               __________

                           Serial No. 106-232

                               __________

       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

_______________________________________________________________________
 For sale by the Superintendent of Documents, U.S. Government Printing 
                                 Office

Internet: bookstore.gpo.gov  Phone: (202) 512-1800  Fax: (202) 512-2250
               Mail: Stop SSOP, Washington, DC 20402-0001

                     COMMITTEE ON GOVERNMENT REFORM

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

                      Kevin Binger, Staff Director
                 Daniel R. Moll, Deputy Staff Director
                     James C. Wilson, Chief Counsel
                        Robert A. Briggs, Clerk
                 Phil Schiliro, Minority Staff Director

                            C O N T E N T S

                              ----------                              
                                                                   Page
Hearing held on July 18, 2000....................................     1
Statement of:
    Redwood, Lyn, Tyrone, GA; Sallie Bernard, Cranford, NJ; 
      Albert Enayati, Pyramus, NJ; Elizabeth Birt, Chicago, IL; 
      Dr. Stephanie Cave, Baton Rouge, LA; Dr. H. Vasken 
      Aposhian, professor of molecular and cellular biology, and 
      pharmacology, University of Arizona; and Dr. Sharon 
      Humiston, Pittsford, NY....................................    12
    Trovato, E. Ramona, Director, Office of Children's Health 
      Protection, U.S. Environmental Protection Agency; Dr. 
      William Egan, Acting Office Director, Office of Vaccine 
      Research and Review, Center for Biologics Evaluation and 
      Research [CBER], FDA; Dr. Roger H. Bernier, Associate 
      Director for Science, National Immunization Program, 
      Centers for Disease Control and Prevention; and Dr. Marie 
      Bristol-Power, National Institute of Health and Human 
      Development, National Institute of Health..................   227
Letters, statements, etc., submitted for the record by:
    Aposhian, Dr. H. Vasken, professor of molecular and cellular 
      biology, and pharmacology, University of Arizona, prepared 
      statement of...............................................   201
    Bernard, Sallie, Cranford, NJ, prepared statement of.........    21
    Bernier, Dr. Roger H., Associate Director for Science, 
      National Immunization Program, Centers for Disease Control 
      and Prevention, prepared statement of......................   253
    Birt, Elizabeth, Chicago, IL, prepared statement of..........   163
    Bristol-Power, Dr. Marie, National Institute of Health and 
      Human Development, National Institute of Health, prepared 
      statement of...............................................   270
    Cave, Dr. Stephanie, Baton Rouge, LA, prepared statement of..   179
    Chenoweth-Hage, Hon. Helen, a Representative in Congress from 
      the State of Idaho, prepared statement of..................   216
    Egan, Dr. William, Acting Office Director, Office of Vaccine 
      Research and Review, Center for Biologics Evaluation and 
      Research [CBER], FDA, prepared statement of................   236
    Gilman, Hon. Benjamin A., a Representative in Congress from 
      the State of New York, prepared statement of...............   220
    Humiston, Dr. Sharon, Pittsford, NY, prepared statement of...   209
    Morella, Hon. Constance A., a Representative in Congress from 
      the State of Maryland, prepared statement of...............     8
    Redwood, Lyn, Tyrone, GA, article entitled, ``Mercury and 
      Autism''...................................................    15
    Schakowsky, Hon. Janice D., a Representative in Congress from 
      the State of Illinois, prepared statement of...............    11
    Trovato, E. Ramona, Director, Office of Children's Health 
      Protection, U.S. Environmental Protection Agency, prepared 
      statement of...............................................   229

         MERCURY IN MEDICINE--ARE WE TAKING UNNECESSARY RISKS?

                              ----------                              

                         TUESDAY, JULY 18, 2000

                          House of Representatives,
                            Committee on Government Reform,
                                                    Washington, DC.
    The committee met, pursuant to notice, at 1 p.m., in room 
2154, Rayburn House Office Building, Hon. Dan Burton (chairman 
of the committee) presiding.
    Present: Representatives Burton, Gilman, Morella, Ros-
Lehtinen, Chenoweth-Hage, Waxman, Maloney, Norton, Cummings, 
Kucinich, Davis of Illinois, and Schakowsky.
    Also present: Mr. Weldon.
    Staff present: Kevin Binger, staff director; David A. Kass, 
deputy counsel and parliamentarian; S. Elizabeth Clay, Nicole 
Petrosino, and Nat Weinecke, professional staff members; Robert 
Briggs, clerk; Robin Butler, office manager; Michael Canty, 
legislative aide; Toni Lightle, legislative assistant; Leneal 
Scott, computer systems manager; John Sare, staff assistant; 
Corinne Zaccagnini, systems administrator; Phil Schiliro, 
minority staff director; Phil Barnett, minority chief counsel; 
Sarah Despres, minority counsel; Ellen Rayner, minority chief 
clerk; and Jean Gosa and Earley Green, minority assistant 
clerks.
    Mr. Burton. 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.
    For the last year, the Government Reform Committee has been 
looking at issues regarding vaccine safety, research and 
policy. A few people have tried to portray this investigation 
as anti-vaccine. Nothing could be further from the truth. Safe, 
effective vaccines save lives. On the other hand, vaccines that 
have not been thoroughly tested and reviewed can be dangerous. 
The rotavirus vaccine was a good example. The government and 
manufacturers ignored the warning signs. A lot of babies were 
injured and required surgery. One baby died before the vaccine 
was pulled off the market.
    Is it irresponsible to ask questions about why that 
happened? Of course not.
    We have a lot of doctors who serve on Federal advisory 
committees who have serious conflict of interest problems. They 
are allowed to vote on vaccines made by companies that they get 
money from.
    Is it irresponsible to ask questions about conflicts of 
interest? Of course not, especially where public health and 
safety are concerned.
    Today we are holding a hearing about why mercury is put 
into vaccines that are given to children. Is that 
irresponsible? Of course not.
    If someone holds hearings about mismanagement at the 
Department of Education, that does not mean they are anti-
education. That means they want our educational system to be as 
well run as possible. That is the way that I feel about our 
vaccine policies. No area is so sacrosanct that the world will 
come to an end if we ask some sensible questions and expect to 
get some sensible answers.
    I think this kind of oversight will make our vaccine 
program stronger not weaker.
    This spring we held a hearing about possible connections 
between autism and the MMR vaccine. We heard lots of testimony 
on both sides of the issue. After the hearing, I sent a letter 
to Secretary Shalala. So did Congressman Waxman. We both asked 
her to put together a panel of the best experts in the field to 
look at this issue. That was May 16--2 months ago. No response.
    That's intolerable. If your position is that we should base 
our policies on good science and good research, then fine. I 
agree with you 100 percent. But if you are not willing to do 
the research, if you're not willing to ask the questions, then 
we have a real problem on our hands.
    I believe that our primary focus on vaccine policy should 
always be what is best for the children. We need to insure that 
only vaccines that are truly needed to protect the public 
health are added to the childhood immunization schedule. At no 
time should the interests of vaccine developers be a higher 
priority than our children's health and well-being.
    Vaccines are the only drugs that Americans are required by 
a government agency to take. It is thus imperative that the 
Federal Government ensures the safety of these mandated 
vaccines. Each State sets a schedule for the vaccines a child 
must receive in order to attend school or day care. The States 
rely on the Federal Government for guidance on which vaccines 
should be mandated. The Federal Government is also the largest 
purchaser of vaccines.
    That brings us to today's hearing topic--mercury in 
medicine. This should be a no-brainer. We all know that mercury 
is a toxic substance. Long-term exposure to low levels of 
mercury has been linked to mental retardation, cerebral palsy 
and central nervous system disorders. We assume that the FDA 
will protect our children from exposure to any level of mercury 
through drugs. But that hasn't been the case. Thimerosal was 
first marketed in 1930 and has become the most widely used 
preservative in vaccines. It is present in over 50 licensed 
vaccines.
    The FDA recently acknowledged that in the first 6 months of 
life children get more mercury than is considered safe by the 
EPA. The truth is that sometimes kids go to their doctor's 
office and get four or five vaccines at the same time. My 
grandson received vaccines for nine different diseases in 1 
day. He may have been exposed to 62.5 micrograms of mercury in 
1 day through his vaccines. According to his weight, the 
maximum safe level of mercury he should have been exposed to in 
1 day is 1.5 micrograms, so that is 41 times the amount at 
which harm can be caused.
    How much mercury are kids being exposed to at once? One 
would think that the FDA would have moved aggressively to 
remove vaccines that contain mercury from the market 
immediately. They did not. On July 9, 1999, the American 
Academy of Pediatrics and the U.S. Public Health Service issued 
a joint statement recommending the removal of all thimerosal 
from vaccines. On May 31, 2000, the Food and Drug 
Administration notified vaccine manufacturers that the review 
of mercury compounds in drugs and foods concluded that reducing 
or eliminated thimerosal from vaccines is merited. However, 
there has been no mandatory action. These vaccines are still in 
use.
    The FDA continues to allow the mercury containing vaccines 
to remain on the market. Today, over 8,000 children in America 
may be given a toxic dose of mercury in their vaccines.
    Many parents who have contacted the committee are concerned 
about other ingredients as well, including formaldehyde, MSG, 
and aluminum. We have also been contacted by many individuals 
who have concerns about mercury in dental amalgams. While this 
is not the focus of today's hearing, it certainly warrants 
discussion as well.
    Congress directed the Environmental Protection Agency to 
contract with the National Research Council to prepare 
recommendations on the appropriate dose for mercury exposure. 
That report was released on July 11. While the FDA relies on 
the Agency for Toxic Substances and Disease Registry's dosing 
level for mercury of 0.5 micrograms per kilogram of body weight 
per day, this is significantly higher than the EPA's dose of 
0.1 microgram per kilogram of body weight. In that report it 
was confirmed that the EPA's reference dose is correct. We will 
hear from Dr. Vasken Aposhian, University of Arizona at Tucson, 
one of the scientists who worked on this report. Romana Trovato 
will testify on behalf of the Environmental Protection Agency.
    Section 413 of the Food and Drug Administration 
Modernization Act of 1997 required the FDA to compile a list of 
drugs and foods that contain internally introduced mercury 
compounds, and provide a quantitative and qualitative analysis 
of the mercury compounds in this list. The act also requires 
the agency to compile the list and provide the analysis within 
2 years after the date of its enactment on November 21, 1997. 
Dr. William Egan will be testifying on behalf of the FDA today.
    While thimerosal has previously been ruled by the FDA to 
fit the ``generally recognized as safe'' standard, when the FDA 
conducted their over the counter drug review they changed their 
minds. The FDA determined that mercury compounds used as active 
ingredients in over the counter drug products were not found to 
be generally recognized as safe. Additionally, the FDA has not 
approved any mercury containing compounds as food additives and 
does not consider any mercury containing compounds to be 
generally recognized as safe. On their own Website, the FDA 
states, ``lead, cadmium, and mercury are examples of elements 
that are toxic when present at relatively low levels.''
    How is it that mercury is not safe for food additives and 
over the counter drug products but it is safe in our vaccines 
and dental amalgams?
    Dr. Roger H. Bernier, Associate Director for Science at the 
National Immunization Program, Centers for Disease Control and 
Prevention, will testify regarding the recent discussion of the 
Advisory Committee on Immunization Practices regarding 
thimerosal.
    Autism is a syndrome characterized by impairments in social 
relatedness and communication, repetitive behaviors, abnormal 
movements, and sensory dysfunction. Autism may now affect 1 in 
150 U.S. children. We will hear from Dr. Marie Bristol-Power of 
the National Institutes of Health regarding the existing 
research in autism. The characteristics of autism and of 
mercury poisoning are strikingly similar.
    Dr. Stephanie Cave, a physician from Baton Rogue, LA will 
be testifying about the mercury toxicity she is seeing in the 
200 autistic children she has as patients.
    Autism strikes families from a diverse background. We will 
hear from five parents today. Elizabeth Birt of Chicago, an 
attorney and mother of an autistic child, will be testifying 
about the need to remove mercury from all vaccines and a 
citizens petition that is being presented to the FDA making 
this request.
    Several parents with scientific and medical backgrounds 
have written a report entitled ``Autism: A Unique Type of 
Mercury Poisoning.'' Three of these parents will be testifying 
today. The lead author of the report is Sallie Bernard of 
Cranford, NJ. Lyn Redwood of Tyrone, GA is a nurse 
practitioner, and Albert Enayati of Paramus, NJ is a chemist. 
Dr. Sharon Humiston, a doctor with an autistic child, will also 
be testifying.
    Our children are the future of this country. As a 
government, we have a responsibility to do everything within 
our power to protect them from harm, including insuring that 
vaccines are safe and effective. Every day that these mercury 
containing vaccines remain on the market is another day we are 
putting 8,000 children that day at risk.
    The record will remain open until August 1, 2000.
    Now I will recognize my colleague, Mr. Waxman, for his 
opening statement.
    Mr. Waxman. Today we are having another hearing to 
highlight allegations of the safety of vaccines.
    In April this committee held a hearing to publicize the 
chairman's theory that certain vaccines, particularly the MMR 
vaccine, cause autism. This theory is based mainly on 
speculation. As the American Medical Association concluded 
recently, ``Scientific data does not support a causal 
association between vaccination and autism.''
    Today we are going to hear testimony about a new theory, 
that there is a link between autism and the mercury-based 
vaccine preservative called thimerosal. It should be noted that 
the MMR vaccine does not contain thimerosal. So this new theory 
is directed at childhood vaccines other than the measles, mumps 
and the rubella vaccine.
    As I said in April, we must not get ahead of the science or 
raise false alarms. The best answers come from research that 
can withstand the rigors of the scientific method. These 
standards have been developed in order to find the truth. But 
if allegations are raised without scientific evidence, we risk 
scaring parents into foregoing potentially life saving 
childhood immunizations.
    Regrettably I fear that once again we are proceeding 
without a sound scientific basis.
    This hearing today combines two issues that I have worked 
on for years, autism and mercury. I have been a strong 
supporter of research and treatment for autism. I am a current 
sponsor of autism research and surveillance legislation, H.R. 
997 and H.R. 274. I was also a leading supporter and sponsor of 
the Work Incentives Program Act of 1999, the American 
Disabilities Act of 1990 and the Developmental Disabilities 
Assistance and Bill of Rights Act of 1990, which are all laws 
of tremendous importance to persons with autism.
    And in 1993, when I was chairman of the House Commerce 
Subcommittee on Health and the Environment, I was the lead 
sponsor of the NIH Revitalization Act, which reauthorized 
expanded funding for and strengthened NIH research into autism 
and childhood health.
    I have also been very concerned about public exposure to 
mercury. For example, last year I introduced the Clean 
Smokestacks Act, H.R. 2900, to reduce methyl mercury emissions 
from power plants by 90 percent. As a National Academy of 
Sciences report confirmed only last week, these emissions pose 
a significant health threat and must be reduced. Methyl mercury 
contamination has caused 40 States to issue warnings about fish 
consumption. Human exposure to eating contaminated fish can 
cause numerous adverse health affects such as losses of sensory 
or cognitive ability, delays in developmental milestones, birth 
defects, tremors, convulsions and even death.
    Currently, my legislation to reduce mercury emissions has 
over 100 bipartisan cosponsors, but it hasn't even been called 
up for a hearing, let alone movement by the leadership of the 
committee that has jurisdiction. For the last two Congresses, I 
have also introduced bipartisan legislation to require better 
public disclosure of mercury pollution. This legislation has 
over 100 bipartisan cosponsors, and I point this out to 
illustrate that I take the issue of mercury very seriously. 
Where we have a reasonable basis for taking action I believe 
that the Congress and agencies should expeditiously work to 
protect the public health from mercury exposure.
    For this reason I strongly support the efforts by FDA to 
eliminate the use of thimerosal in vaccines. Thimerosal is a 
preservative that contains ethyl mercury. Although less is 
known about the effects of ethyl mercury in thimerosal than 
about the effect of ethyl mercury from power plant emissions, 
ethyl mercury may pose similar health risks. It is appropriate, 
therefore, that thimerosal be phased out of vaccines.
    This process is well underway. The maximum exposure to 
mercury through vaccines today is 60 percent of what it was a 
year ago. The entire childhood immunization schedule is 
currently available without thimerosal and FDA expects all 
vaccines to be thimerosal free by the first quarter of next 
year.
    The question this hearing poses, however, is not whether 
mercury-containing thimerosal should be in vaccines in the 
United States. FDA decided a year ago that it should not. 
Rather, the purpose of this hearing appears to be to publicize 
the theory that thimerosal is causing autism.
    The evidence to support this theory is virtually 
nonexistent. I fear that once again we are pursuing an anti-
vaccine agenda in disregard for the scientific and medical 
consensus on the safety of vaccines.
    The chairman has held a series of hearings on questioning 
vaccine safety, the public health benefits of childhood 
immunizations and the integrity of the scientists, health 
professionals and public servants working to immunize our 
children. The chairman has promoted allegations that MMR 
vaccines causes autism. He has provided a forum for allegations 
that vaccines can cause diabetes, and he has alleged that 
parents should be skeptical about vaccines because our 
government is beholden to the drug industry.
    Well, this is a backward attitude to take at a time when 
vaccines promise more than ever to improve human health.
    I will read and listen to the testimony of the witnesses 
today very attentively. I want to thank the parents who are 
coming here and testifying. It takes a lot of courage to share 
your personal experiences with Congress.
    We have other things going on at the same time as this 
hearing, which keeps us from being able to attend the hearing 
in full, and I will be in and out and I want to apologize to 
those witnesses. The written testimony will be part of the 
record. I will have a chance to review it. My staff will be 
here and will have an opportunity to report to me on all of the 
testimony that is given orally that may supplement the written 
record as well.
    Thank you, Mr. Chairman, for this chance to give an opening 
statement.
    Mr. Burton. Before we ask any other Members if they would 
like to make an opening statement, we have Dr. Weldon, 
Congressman Weldon, who is very interested in this subject, and 
I would like to ask unanimous consent that he be able to 
participate in the hearing.
    Mr. Waxman. Reserving the right to object, I am not going 
to object to him sitting in and being able to hear the 
testimony and pursue questions, but that is unusual because 
usually you have only members of the committee participate and 
if we allowed all Members to come in, it could delay many 
hearings to a great extent. But we want to accommodate this 
request and I certainly want to accommodate Dr. Weldon, for 
whom I have a great deal of respect.
    We have 11 witnesses testifying today, and we on the 
minority asked for four witnesses and we were only accommodated 
by getting three. Now, when I say we were accommodated, we 
asked that the Centers for Disease Control be allowed to 
testify. We asked for a witness from NIH to testify. It 
shouldn't be a request of ours, it is no favor to us to have 
them testify. In any balanced hearing we certainly ought to 
have these people in to testify as well as those who are going 
to come in and express a particular point of view. We requested 
four witnesses and we got three. One more witness would have 
taken 5 minutes of testimony because that is what we allow each 
witness to take in giving oral testimony. Mr. Weldon will have 
an opportunity to ask questions at least 5 minutes one round--
--
    Mr. Weldon. Would the gentleman yield.
    Mr. Waxman. In a minute. I welcome that because I think he 
will bring out information, but it just troubles me that while 
we try to be accommodating, I find it incomprehensible why the 
majority of the committee and the chairman of this committee is 
not accommodating our requests.
    And I yield to the gentleman, and I do not object and I 
welcome you because you have a special interest and expertise.
    Mr. Weldon. I thank the gentleman's kindness and I just 
want to point out that I have another hearing to go to in 30 
minutes, so I doubt that I will be able to get in any oral 
questions.
    Mr. Waxman. I don't object to you participating and asking 
questions. I point out the reluctance of the majority to have a 
fair and full and open hearing and accommodate all of the 
witnesses who have something to add, even if they may have 
something to add on a point that the chairman may disagree 
with. I withdraw my reservation.
    Mr. Burton. Without objection, so ordered. Do any other 
members have opening statements?
    Representative Morella.
    Mrs. Morella. Mr. Chairman, I just ask the fact that my 
written statement be included in the record and I just want to 
comment on the fact that I appreciate your efforts to hold this 
hearing on mercury and medicine, and I look forward to hearing 
the testimony of the witnesses. I really want to learn more 
about mercury and medicine and vaccines specifically.
    In Montgomery County, the incidence of autism in our 
children is alarming, and some do feel that autism may be 
related to vaccines, but I am concerned about the lack of 
information and misinformation surrounding the issue of 
vaccines and its possible relationship to autism, so that I 
hope that today we can come to a conclusion on what the 
appropriate steps are for this committee and the government to 
take.
    So with your approval, the rest of my opening statement I 
would like to have in the record.
    Mr. Burton. Without objection, so ordered.
    [The prepared statement of Hon. Constance A. Morella 
follows:]

[GRAPHIC] [TIFF OMITTED] T2722.001

[GRAPHIC] [TIFF OMITTED] T2722.002

    Mr. Burton. Ms. Schakowsky.
    Ms. Schakowsky. Thank you, Mr. Chairman. I will not be able 
to stay for all of today's hearing. I would like unanimous 
consent to submit some questions for the EPA and to the FDA for 
the record.
    Mr. Burton. Without objection, so ordered.
    [The prepared statement of Ms. Schakowsky follows:]

    [GRAPHIC] [TIFF OMITTED] T2722.003
    
    Ms. Schakowsky. I also want to take a moment to welcome all 
of the witnesses, but particularly Ms. Birt. While not a 
constituent of mine, we live in neighboring towns and the two 
of us have exchanged letters in the past. Again, a thank you to 
all of the witnesses for being here, and I yield back the 
balance of my time.
    Mr. Burton. Mrs. Maloney.
    Mrs. Maloney. I would like to put my opening statement in 
the record so we can hear from the witnesses. Thank you.
    Mr. Burton. Without objection, so ordered. We will now 
welcome our first panel to the witness table, Ms. Redwood, Ms. 
Bernard, Mr. Enayati, Ms. Birt, Dr. Cave, Dr. Aposhian and Dr. 
Humiston.
    [Witnesses sworn.]
    Mr. Burton. Ms. Redwood, if you can confine your remarks to 
5 minutes. Ms. Redwood.

    STATEMENTS OF LYN REDWOOD, TYRONE, GA; SALLIE BERNARD, 
  CRANFORD, NJ; ALBERT ENAYATI, PYRAMUS, NJ; ELIZABETH BIRT, 
CHICAGO, IL; DR. STEPHANIE CAVE, BATON ROUGE, LA; DR. H. VASKEN 
  APOSHIAN, PROFESSOR OF MOLECULAR AND CELLULAR BIOLOGY, AND 
 PHARMACOLOGY, UNIVERSITY OF ARIZONA; AND DR. SHARON HUMISTON, 
                         PITTSFORD, NY

    Ms. Redwood. Chairman Burton, Congressman Waxman and 
committee members, I want to thank you for holding this hearing 
today and inviting me to testify on this important issue. My 
name Lyn Redwood. I reside in Atlanta, GA with my husband Tommy 
and three children, Hanna, Drew and Will. My husband and I are 
both health care professionals. My husband is a physician, and 
I am nurse practitioner. I also hold a master's degree in 
community health nursing and I am a member of our county's 
Board of Health and Local Planning Commission.
    My son Will weighed in at close to 9 pounds at birth. He 
was a happy baby who ate and slept well, smiled, cooed, walked 
and talked all by 1 year of age. Shortly after his first 
birthday, he experienced multiple infections, lost speech, eye 
contact and developed a very limited diet and suffered 
intermittent bouts of diarrhea. He underwent multiple 
evaluations and was initially diagnosed with a global receptive 
and expressive speech delay and later with pervasive 
developmental disorder, a form of autism.
    I would never have made a correlation between my son's 
disability and vaccines until July 1999, when I read that a 
preservative, thimerosal, utilized in some infant vaccines 
actually contained 49.6 percent mercury. The report said that 
the FDA had determined that ``infants who received thimerosal-
containing vaccines at several visits may be exposed to more 
mercury than recommended by Federal guidelines for total 
mercury exposure.'' As health care providers, my husband and I 
constantly receive notices that adverse events have been 
reported with a drug or product safety sheets have been 
revised, and I was wondering why no such notices were sent out 
notifying us that thimerosal preservative vaccines were 
exceeding Federal guidelines for mercury exposure in infants.
    It was in light of this information that I reviewed my 
son's vaccine record and my worse fears were confirmed. All of 
his early vaccines that could have possibly contained 
thimerosal, had. From my research on mercury, I have found it 
to be a potent human toxin, which is especially damaging to the 
rapidly developing fetal and infant brain. While acceptable 
levels for exposure are published by Federal agencies, mercury 
is a poison at any level.
    The dose thought to be safely allowed on a daily basis by 
EPA is 0.1 micrograms per kilogram of body weight. At 2 months 
of age my son had received 62.5 micrograms of mercury from 
three infant vaccines. According to this EPA criteria, his 
allowable dose was only 0.5 micrograms based upon his weight. 
He had received 125 times his allowable exposure on that day. 
These large injected bolus exposures continued at 2 months, 4 
months, 12 months and 18 months to a total mercury exposure of 
237.5 micrograms. I also discovered that the injections that I 
received during my pregnancy, the first and third trimesters, 
and hours after the delivery of my son to prevent RH blood 
incompatibility disease also contained mercury.
    Knowing that the major effect of mercury compounds is 
neurotoxicity, I questioned if these exposures could account 
for my son's regression and disability. Since he was now 5\1/2\ 
years old, it would be difficult for me to know what his 
mercury levels had been at that time. It was then that I 
remembered having kept a lock of hair from his first haircut at 
20 months of age. Heavy metal analysis detected 4.8 parts per 
million mercury in his hair, the allowable levels being less 
than 1 part per million. The EPA action level in hair is 1 part 
per million as well, and 5 parts per million is considered 
diagnostic for mercury toxicity.
    Since my son has never eaten fish nor seafood nor had 
dental amalgams, I had no other identifiable source for his 
mercury levels outside of the thimerosal exposure from his 
vaccines and my RhoGAM injections.
    Since last fall I have spent every free moment researching 
this issue. As a nurse and a member of the Board of Health for 
our county, I felt an urgency to share my findings and concerns 
about thimerosal with other professionals. I did research and 
made phone calls, and I wrote letters and I actually went in 
person to Washington to meet with FDA and CDC officials to 
voice my concerns and present data on documented levels of 
mercury in many other children with developmental delays who 
were also exposed to thimerosal in their vaccines. All of my 
efforts seemed to fall on deaf ears.
    On June 21, 2000 I attended the Advisory Committee for 
Immunization Practices meeting held in Atlanta. At that meeting 
a study was presented that looked at Vaccine Safety Datalink 
information and thimerosal exposure in over 120,000 children. 
The key findings of the study were significant associations 
between thimerosal exposure and ADD, tics, speech and language 
delay and neurodevelopmental delays in general. A panel of 
experts who were convened to review the data who concluded, 
``The findings support a statistically significant, albeit weak 
association, but that the implications are profound.''
    Unfortunately, ACIP chose not to give preference to 
thimerosal free vaccines, even though the vaccine manufacturers 
present at this meeting assured there was enough supply 
available to meet vaccine needs the first 6 months of life. 
From the comments made by ACIP committee members it was 
apparent that political and economic concerns for the vaccine 
program had taken precedence over the health, safety and 
welfare of the children it is charged to protect. One committee 
member even remarked that giving preference for thimerosal free 
vaccines may result in reduced public confidence in vaccine 
programs. From my own personal perspective, just the opposite 
has occurred.
    You may hear today from some officials that the mercury 
exposure from medicinal sources is insignificant. The fact is 
that neurological damage is documented to occur in infants at 
these levels of exposure. You may also hear that these levels 
of exposure only exceed EPA guidelines the first 6 months of 
life. That is because the data was inaccurately averaged over a 
6-month period of time. As any independent toxicologist will 
tell you, mercury has a long half-life and its inherent 
pharmacokinetics you cannot legitimately calculate the effect 
of a bolus dose as though it were ingested in small amounts 
over a long period of time. To make a simple analogy, what FDA 
is trying to assert is that giving someone two Tylenol a day 
for 30 days has the same effect of giving them 60 Tylenol all 
at once in 1 day. This defies common sense, much less sound 
medical practice.
    The truth is vaccines are the single largest source of 
mercury exposure postnatally in infants, but nowhere in the 
mercury literature of EPA, FDA, ATSDR are these products even 
identified as being a source of exposure. When I spoke with one 
official from EPA, he commented that my son's exposure was very 
high and was rather sympathetic, but since it was not an 
environmental exposure, his agency could not get involved. So 
whom do I turn to for help?
    Over 1 year ago the FDA, AAP and the Public Health Service 
called for the immediate elimination of reduction of thimerosal 
from vaccines, but the sad truth is that while some progress 
has been made, infants continue to be injected with one of the 
most neurotoxic metals on Earth in excess of Federal safety 
guidelines as I speak here today, and the responsible agencies 
are unwilling to address this issue.
    We are in the midst of an autism epidemic and children 
diagnosed with learning disabilities continue to increase 
daily. The statement that there is no evidence of harm does not 
equate with no harm not having occurred. The truth is that we 
have not adequately looked or we just refuse to see.
    A recent national news article which addressed these 
concerns reported that some may say we don't have a smoking gun 
but the truth is the bullets are all over the floor. Millions 
of children have been needlessly exposed to toxic acts from 
federally sponsored vaccine programs and have suffered 
neurological damage. This problem has become so pervasive in 
our society that few are left untouched, as Chairman Burton 
well knows. It is time for someone to step forward and 
acknowledge these facts and provide the science to fully 
investigate what has happened to our children and what can be 
done to help them.
    Thank you.
    [The information referred to follows:]

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    Mr. Burton. Ms. Bernard.
    Ms. Bernard. I have some slides.
    Mr. Burton. We will put those up on the screen as you 
speak.
    Ms. Bernard. Chairman Burton, Congressman Waxman and other 
distinguished members of this committee, thank you for holding 
this hearing to examine the possible role of mercury and 
thimerosal in causing neurodevelopmental disorders.
    My name is Sallie Bernard. I live in New Jersey. I am the 
mother of triplets, age 12, Fred, Jimmy and Billy. After 
meeting all of his developmental milestones on schedule and 
receiving unremarkable pediatric reports up to age 2\1/2\, 
Billy began to exhibit slower word acquisition than his 
brothers, articulation difficulties and attentional problems. 
At 3\1/2\ he was diagnosed with language dysphasia and 
attention deficit hyperactivity disorder. At age 4\1/2\ he was 
diagnosed with autism.
    Anyone familiar with the signs of mercury toxicity in 
children will recognize language difficulties and ADHD traits 
as common features. But in fact, research conducted by me and 
others has shown that the characteristics of autism itself are 
identical to those arising from mercury exposure.
    This chart that I have up here shows only some of the 
similarities between autism and mercury poisoning. This shows 
some of the behavioral characteristics of autism and mercury 
poisoning. They include social withdrawal, repetitive and 
compulsive behaviors, language difficulties, sensory 
disturbance, movement disorders, cognitive deficits and unusual 
behaviors like head banging.
    Next slide. This slide shows physiological aspects of 
mercury poisoning and autism. We see the same similarities, 
damage to the same brain areas, EEG patterns, and so forth.
    The next slide. On the population characteristics, males 
more affected than females for both disorders and the presence 
of a strong genetic component. We feel that these similarities 
are too close to have occurred by chance. We are not alone in 
our thinking. The just released congressionally mandated 
mercury report by the National Academy of Sciences links methyl 
mercury and the environment to neurological deficits in 
children, and we know from researchers such as Suzuki and Magos 
that the ethyl mercury found in thimerosal is as toxic as 
methyl mercury. The latest issue of Environmental Health 
Perspectives also notes that an association has been found 
between exposure to toxic chemicals and various 
neurodevelopmental disorders such as learning disabilities, 
intellectual retardation, attention deficit, hyperactivity 
disorder, autism and propensity to violence.
    It is well-recognized by autism researchers, as reviewed by 
Dr. Bristol-Power and others, that autism is caused by an 
interaction of environmental and genetics factors. Based on 
epidemiological and other data we have proposed that this 
environmental factor is thimerosal from vaccinations acting 
alone or synergistically with other toxins. This is why we 
believe this to be true.
    Next slide. This chart shows the prevalence of autism and 
vaccine history. Thimerosal was first introduced into vaccines 
in the 1930's and autism was first discovered by Leo Kanner in 
the early 1940's among children born in the 1930's. Studies 
prior to 1970 estimated autism to occur in 1 in 2,000 children 
while studies after 1970 showed the prevalence at about 1 in 
1,000. This was also a period of increased immunization of 
American children. In 1996 the NIH has estimated the rate of 
autism to be higher at 1 in 500, and just this year the CDC has 
found 1 in 250 children affected with classic autism. This 
dramatic increase in the past decade coincides with the 
introduction and spread of two new thimerosal containing 
vaccines, the HIB and the hepatitis B.
    Another observation is that autistic symptoms emerge within 
a short time after vaccination, generally following a period of 
normal development. Importantly, the amount of mercury injected 
with each vaccine given as a bolus or spike does greatly 
exceeds EPA and safety guidelines and thus is highly likely to 
be neurotoxic and injurious.
    Last, as Lyn noted, a recent CDC study has found a 
statistically significant association between thimerosal and 
vaccines specifically, and attention deficit disorders, speech 
delay, motor tics and neurodevelopmental disorders in general.
    Thus, we see the symptoms of autism and mercury poisoning 
are the same and the epidemiological and exposure data are 
highly supportive of a thimerosal etiology. Since thimerosal is 
not a necessary component of vaccines and every child can be 
fully immunized today with a non-thimerosal alternative, 
thimerosal should no longer be allowed in vaccines.
    Congress, again listening to the needs of citizens, passed 
legislation in 1997 requiring government agencies to review 
thimerosal content in products. In response, the FDA 
investigated thimerosal in vaccines and found that no safety 
studies had ever been conducted on this substance.
    As a parent, this is very disconcerting indeed. Vaccines 
are recognized as the crown jewels of the U.S. Public Health 
Service and their effectiveness relies on the willingness of 
parents to bring their children in to be immunized. By not 
conducting safety studies and then not taking immediate steps 
to ban thimerosal once its potential for harm was publicly 
recognized, this program has been put at great risk. What 
parent will want their baby injected repeatedly with a known 
neurotoxin? How much confidence will parents have that our 
national vaccine program really cares about safety? Parents 
like me already have their doubts that it does.
    I hope that Congress will respond once again with effective 
action to ensure the safety and well-being of all our children 
in light of the information now presented. Thank you.
    [The prepared statement of Ms. Bernard follows:]

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    Mr. Burton. Thank you.
    Mr. Enayati.
    Mr. Enayati. Good afternoon. My name is Albert Enayati. I 
am president of the Cure Autism Now! Foundation, New Jersey 
chapter. Our foundation headquarters are located in Congressman 
Waxman's district. My wife Sima and I are scientists who have 
worked for pharmaceutical companies. We have a child with 
autism.
    Mr. Chairman, in 1971, when my wife and I were growing up 
in Iran, a tragic event was taking place in our neighboring 
country Iraq. In October of that year, Iraq imported more than 
90,000 tons of grain treated with methyl mercury. Much of the 
grain was used as daily baked bread. The reports from Iraq were 
shocking. The extensive mercury poisoning caused thousands of 
Iraq farmers and their families to become neurologically 
damaged. Hundreds died. The Iraqi episode is not unique. 
Similar misfortunes include mercury epidemics in Minamata, 
Japan, Guatemala and Russia. In the first half of the century, 
poisoning of infants and toddlers by mercury in teething 
powders led to acrodynia, or Pink Disease.
    Today, another mercury tragedy is unfolding, this time 
among our children. As a scientist and a parent, I sadly 
declare that ethyl mercury in vaccines has been causing autism, 
attention deficit disorder and other neurodevelopmental 
diseases in children who, as susceptible infants and toddlers, 
were injected with thimerosal, a vaccine preservative which is 
49.6 percent ethyl mercury by weight.
    In 1982, 18 years ago, an FDA panel concluded that 
thimerosal is toxic, causes cell damage, can cause allergic 
reactions, and is not effective in killing bacteria or halting 
their replication. A recent hepatitis control report details 
how FDA, via its own Committee on Biologics, had failed, for 17 
years, since the 1982 report, to follow their own 
organizational directives which specify ensuring product 
safety. Fortunately, because of the FDA Modernization Act of 
1997, the CBER was forced to evaluate thimerosal in vaccines.
    By 1998, the CBER's thimerosal study had run into 
difficulty. It is against Federal statutes to add toxic 
material to childhood vaccines, and thimerosal appeared to be 
contrary to this important law. CBER staff then searched for 
safety data and guidelines but found none. In fact, the CBER 
learned that there is very limited literature available on 
ethyl mercury.
    The CBER team then compared ethyl mercury intake with 
Federal guidelines for safe mercury intake, but again the CBER 
ran into difficulty. Thimerosal is injected in bolus doses and 
metabolized in humans to ethyl mercury but all theoretical 
guidelines for safe mercury intake were based upon ingested 
methyl mercury. Left with no choice, the CBER team assumed that 
the toxicity of thimerosal injected in bolus doses was 
equivalent to that of methyl mercury ingested gradually.
    Armed with this assumption, they compared the vaccinal 
ethyl mercury intake in children 6 months old to the suggested 
safe limits by EPA. It was then that they made a remarkable 
discovery: Even without considering infants and toddlers' 
susceptibility to neurotoxic effects, the mercury intake from 
vaccinations in the first 6 months of life far exceeded the 
limit set by EPA.
    I believe that the FDA record justifies concluding that the 
U.S. immunization program has been in violation of Federal 
statutes. Presumptions about safety have superseded safety 
guidelines and appropriate testing. Dangerous substances in 
vaccines remain untested. This negligence is inexcusable. 
Thousands of children and their families have been 
neurologically impaired by physician-injected ethyl mercury and 
while this has happened, the responsible supervisory agency, 
the FDA, was asleep at the wheel.
    Mr. Chairman, despite the FDA warning in 1982 and the known 
toxicity of thimerosal, the FDA allowed the continued injection 
of cell damaging neurotoxic product into our children. 
Furthermore, since 1990, the FDA and CDC increased the 
likelihood of neurological damage by allowing thimerosal to be 
injected into day-old and 2-month-old infants. I am here 
because of my son Payam. For more than a year, he passed his 
developmental milestones, but after his DPT and MMR shots, 
Payam began not responding to his name, no longer ran to greet 
me when I returned from work. His spoken language disappeared 
and he no longer responded to his parent's words. Within a few 
months he had begun biting himself, hitting his head against 
the wall, flapping hands, toe walking and running aimlessly 
around the house. Even sleep patterns had deteriorated. All 
these traits appear in medical literature about mercury 
poisoning. Mr. Chairman, every symptom of my son's autism 
parallels traits known in mercury poisoning.
    Many experts would have us believe that my son's regression 
was coincident with his vaccination. However, as a trained 
scientist, my reading of mercury literature indicates that 
every trait that defines autism can be induced by organic 
mercury. Not surprisingly, the FDA and CDC have asked vaccine 
producers to initiate a gradual discontinuance of using 
vaccines containing thimerosal. However, no family needs a 
neurologically impaired child. Injecting ethyl mercury in 
infants and toddlers ought to be discontinued immediately and 
clinical research to be initiated regarding mechanisms of 
treatment.
    Thank you, Mr. Chairman.
    Mr. Burton. Thank you. Ms. Birt.
    Ms. Birt. Thank you. My name is Liz Birt. I live in 
Wilmette, IL with my husband and children, Sarah age 8, Matthew 
age 6 and Andrew age 4. I would like to thank you for holding 
this hearing today and allowing me to testify.
    I have sat in this room before as a member of the audience. 
On April 6 of this year I listened as the chairman's opening 
statement detailed in part the story of my son Matthew. Matthew 
is classified as autistic, a diagnosis made entirely on 
behavioral observations. However, he has physical problems, 
including antibodies to myelin basic protein, abnormal EEG, 
inflammatory bowel disease and live measles virus in his 
terminal ileum. Matthew's immunologist at a teaching hospital 
believes that the thimerosal contained in the vaccines 
contributed to the development of these medical conditions and 
they have led to his contraction of the live measles virus by 
priming this immune symptom for an adverse reaction.
    I am also here testifying as an advocate for not only the 
immediate recall of thimerosal containing vaccines but for 
fundamental change. This is unfortunately a failure to assign 
responsibility for vaccines which are mandatory for all 
children. The manufacturers, the FDA and the CDC, NIH and the 
AAP all share responsibility for allowing this neurotoxin to 
remain in vaccines. This is the mandate of the FDA. The 
American public relies on this agency with its scientific 
experts to protect us. Yet for some unknown reason this issue 
was ignored. Why are American children today being exposed to 
vaccines which on a conservative basis subject them to 30 times 
the allowable amount of mercury for an adult? Why weren't the 
most basic calculations done to ensure that these products are 
safe? It is the children like my son who were injured in the 
name of the greater good who, just like the soldiers returning 
from the Vietnam War, are now being ignored.
    I am here today to let the members of the committee know 
that these children have voices, and the voices of their 
parents and the grandparents, some of which are in this room 
today, will be heard however unpleasant the message. We want 
these products off the market immediately. Not one more child 
should be vaccinated with these vaccines.
    Members of the committee may ask how does a member of the 
public speak with such conviction. Everything that is an 
official governmental publication paints a picture of complete 
safety. However, it does not take a genius to be able to 
discern the truth from the spin, deliberate material 
misrepresentations and even fraud contained in some of these 
publications.
    The CDC's fact sheet on thimerosal states ``thimerosal is a 
mercury containing preservative that has been used since the 
1930's. It is used to ensure the medical products stay potent 
and sterile. It has been used in medicines as well as medical 
products such as throat sprays and contact lens solutions.'' 
This I submit would leave the average American parent to 
conclude that thimerosal is not a toxic substance.
    What is missing is since 1977 clinicians have recognized 
thimerosal as being potentially dangerous. For nearly 20 years 
the U.S. Government has singled out thimerosal as a potential 
toxin. My question to the committee members and to the FDA is: 
Why is thimerosal even in these vaccines if it was determined 
in 1982 by the FDA that it was not even safe or effective as a 
bacteriostatic agent: Why has this product not been recalled?
    This fact sheet states mercury exposures from vaccines 
containing thimerosal are within the safety margins included in 
exposure guidelines established by Federal agencies. The 
reality is there are no established safety margins published by 
any Federal agency for thimerosal exposure in infants and 
toddlers, and American children today are receiving many 
multiples of the EPA daily exposure guidelines for mercury for 
adults.
    Why aren't the parents being told the truth by the CDC? If 
these statements were held to the same standards that we have 
for SEC rules, all of these people would be subject to 
prosecution. The CDC's own Vaccine Safety and Development 
Officer is on record as stating that

    Part of our problem is, unlike efficacy doses where there 
was a real effort on the part of the World Health Organization 
case definition ahead of time, similar efforts were not done 
for safety.
    The CDC is currently working with several large HMOs and a 
large link data base to study adverse events. The data base 
will study single validation, new vaccines and new schedules. 
Future topics could include examining communication of vaccine 
risk and defining the biological basis of groups at risk for 
adverse events.
    Finally, of all of the positive things that were done by 
the Vaccine Compensation Act of 1986, one thing that they more 
or less neglected was research. They found a mechanism to fund 
an injury compensation program after the injury has already 
happened, but there is no way at this point to fund the 
research to try to prevent such injuries.

Why wasn't a safety definition developed? Why isn't it 
important to identify those at risk for adverse vaccine events? 
Why isn't research funded?
    We must have accountability today. Conflicts of interest on 
vaccine committees at the FDA and CDC must be eliminated. The 
stakes are too high. We as parents need information on which to 
base informed consent. When my son was vaccinated at 2 days of 
life, I was only told after the vaccine was given. How can this 
type of process allow parents to receive the type of 
information that they need to make their decisions regarding 
the care of their children? We are the caregivers of our 
children, not these agencies.
    Members of the committee, I urge you to support a petition 
to be filed this week by the Coalition for Safe Minds. This 
petition calls for the immediate recall of all vaccines 
containing thimerosal. These vaccines should never be used. Our 
country is experiencing an epidemic of neurodevelopmental 
disorders. These conditions cause not only heartbreak to the 
affected families, but the financial ramifications are immense 
to our entire country.
    Thank you.
    [The prepared statement of Ms. Birt follows:]
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    Mr. Burton. Thank you.
    Dr. Cave.
    Dr. Cave. My name is Stephanie Cave. I am in family 
practice in Baton Rouge, LA. I want to express my deep 
appreciation to you and to the members of the committee for 
allowing me to testify. I am presently treating over 300 
autistic children, with an additional 150 waiting to get in. 
Dr. Amy Holmes, the physician-parent of an autistic child, 
joined in February to help with the overwhelming numbers of 
children with this problem. We are treating children from all 
over the United States and getting calls from many places 
around the globe. This is truly an epidemic. If you have any 
idea that it is not, I invite you to sit in my office for 2 
hours.
    Mercury can exist as a pure element or in various forms of 
organic and inorganic mercury and it affects the immune system 
and neurological systems at a very basic level. The timing of 
infant vaccines with mercury corresponds to critical periods of 
neuronal development. The blood brain barrier is not fully 
developed in the infant or toddler. The fetus is at risk of 
exposure to toxins during gestation, including methyl mercury 
from seafood eaten by the mother or other sources, Rhogam, 
which we have already mentioned, given at 28 weeks gestation, 
and the influenza vaccine given during pregnancy. These metals 
can be passed not only transplacentally, but also through 
breast milk to the infant at a time when the liver 
detoxification process is not perfected to the point of 
removing the metals.
    We have measured this detoxification process, and we have 
found it to be woefully inadequate in the developmentally 
delayed children. The organic ethylmercury injected in bolus 
through vaccines enters the brain and converts to inorganic 
mercury, which cannot cross back over the blood brain barrier. 
This form is more likely to cause autoimmune antibodies to 
brain tissue, and this is what we are seeing in these children.
    I believe that the introduction of the hepatitis B vaccine 
in 1991 has sparked this recent epidemic because of thimerosal. 
When added to the mercury imparted through the DPT and HIB, the 
exposure to mercury exceeds EPA safe limits for the metal if 
you consider a bolus dose on a single day. The EPA limits are 
usually related to ingested mercury, which is partially cleared 
by the liver. Injecting boluses of ethyl mercury presents an 
entirely different, another scenario. The 2-month dose of 
mercury is at least 30 times higher than the recommended daily 
maximum exposure set by the EPA.
    During the 1990's, infants received 12.5 micrograms of 
mercury at birth, followed by 12.5 micrograms at 1 month, 62.5 
micrograms at 2 months, 50 micrograms at 4 months, 50 
micrograms at 6 months, 50 micrograms at 15 to 18 months; a 
total of 237.5 micrograms for a child who at best weighs 10 
kilograms. This far exceeds the safety limits if you consider 
bolus dosing. Safety limits would be more like 1 to 1.5 
micrograms.
    In establishing normal safety limits, if there is such a 
thing for a metal as toxic as mercury, bolus injections were 
not considered. Consider a nurse giving an injection who is not 
shaking the vial according to directions before drawing out the 
vaccine dose. This would give a chance that child receiving the 
last dose could get as much as 10 times the usual amount in one 
dose.
    There was an article in the Journal of Pediatrics in May 
2000 that showed mercury in the blood of infants at birth prior 
to the hepatitis B injection. After the vaccine, the levels 
rose in the blood of the infants tested. In some preterm 
infants, there were levels that measured 10 times that seen in 
term infants. The bile production is minimal in infancy, making 
it more difficult for metals to be cleared from the body. When 
added to a vaccine, the metals are even more dangerous because 
the vaccines trigger immune reactions that increase the 
permeability of the GI tract and the blood/brain barrier.
    The injection of mercury appears to affect only certain 
children but I fear that we've underestimated the devastation 
by concentrating only on the autistic children. We're measuring 
elevated levels of mercury in other children with milder 
difficulties like learning disabilities, ADHD, Asperger's 
Syndrome and many others. We do not have any idea what the 
scope of this problem is at this point. And there are no safety 
standards for infants getting bolus doses of ethylmercury. We 
cannot compare the effects of a bolus dose in an infant to a 
daily dose in an adult. There are no parameters for comparison.
    We have simplified the problem in our practice. We test all 
developmentally delayed children for the presence of heavy 
metals. Hair is screened, followed by a determination in urine 
after a challenge of an oral chelator, DMSA, and it is rare 
that we find any child with a developmental problem who does 
not have increased levels of mercury in the urine after a 
chelator challenge. An interesting phenomenon is that we are 
finding many more lead-intoxicated children than blood screens 
would indicate. And lead amplifies the toxicity of ethylmercury 
in the brain.
    We performed a number of tests on blood, urine, hair, and 
stool in the autistic children. The abnormal findings that we 
see in autism involving the immune system, GI tract, and 
central nervous system are also seen in mercury poisoning. 
These include but are not limited to changes in T lymphocytes, 
low levels of glutathione, low sulfate levels, IgA deficiency, 
and the presence of myelin basic protein antibodies in the 
brain. The children are responding well to the use of oral 
chelators and supplements which take out heavy metals. We are 
measuring levels in the urine as we treat. The changes in the 
children are remarkable with each dose of a chelator. This 
treatment may take months to complete but the chance for 
recovery is evident on a daily basis.
    Because mercury has such far-reaching effects in the 
destruction of function in many systems of the body, our 
treatment also involves nutritional repletion of cellular 
chemistry, normalization of gastrointestinal bacteria, dietary 
programs and restoration of liver detoxification systems.
    Our medical training did not adequately prepare us for this 
challenge. We have learned little about testing heavy metals 
and even less about treating. The word ``chelation'' is not in 
the vocabulary of most physicians. A few physicians who are 
treating these children are inundated with them in their 
practices now. The good news is that they're responding well to 
the therapy. The changes in neurological functioning are 
remarkable with each day of treatment.
    It is imperative that we stop giving heavy metals to 
children through vaccines when their bodies can least handle 
such an insult. We're seeing the link on a daily basis. The 
children are recovering steadily but the treatment is expensive 
and tedious. It would make more sense for us to eliminate the 
cause of the problem by deleting thimerosal from the vaccines 
now and by withdrawing current lots containing thimerosal from 
pediatric offices and health units. We also need to channel 
funds for research into the clinical trials needed to explore 
the link between mercury and developmental problems in 
children.
    I brought some slides of just a couple of the children 
before and after treatment. It's kind of hard to see. The child 
on the left has a blank stare, he has no speech. On the right 
he's smiling. He is now speaking. He's speaking in sentences. 
And this is following the nutritional treatment and the removal 
of metals.
    Second slide. This is a child before treatment on the left: 
bleary-eyed, no speech at all, irritable, self-injurious, hands 
flapping. And on the right, I think you can see the change. And 
this child had a lot of metal. He had lead, he had mercury, he 
had aluminum. We're finding a lot of aluminum in these 
children. I think aluminum is going to end up being as big a 
problem as mercury if we keep putting it into the vaccines.
    On the left, again no speech, blank eyes, blank stare, 
little frowning look; and on the right, I think you can see the 
mother's smile as well as you can see the child's smile. This 
was a twin, by the way. And she now has two speaking twins.
    One more? OK. I think we're back to the start. Thank you.
    [The prepared statement of Ms. Cave follows:]
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    Mr. Burton. Thank you, Dr. Cave. Sounds like you're doing 
real good work down there. We'll check all the references that 
you used as well as your statement.
    Doctor.
    Mr. Aposhian. May I have the first slide, please?
    Mr. Chairman, members of the committee, I have been asked 
to review mercury toxicity with you for a short period of 5 
minutes. And with your permission, I'll dispense with the usual 
introductory remarks and get to the point.
    May I have the next slide, please? The next slide, please.
    The next slide will tell you about the different forms of 
mercury. We have elemental mercury, we have organic mercury, 
and we have mercuric mercury that we usually call inorganic. 
The elemental mercury you're probably familiar with as far as 
the silvery liquid that most children play with at some time in 
their lives. It is dangerous because it emits mercury vapor at 
room temperature or when it's in our mouth, as we will talk 
about in a moment. It's a very dangerous poison.
    The organic mercury, methylmercury, comes from fish--the 
fish that you eat, certain kinds of fish. And thimerosal comes 
from the vaccines and other medical preparations. A recent FDA 
list pointed out there are 217 medical preparations listed with 
the FDA that contain organic mercurials; 217.
    And finally, the slide mentions mercuric mercury that we'll 
speak about in a moment. As far as the sources and forms of 
brain mercury, this is shown in the next slide. You may not be 
able to see that, but on the left is a tooth, underneath is 
thimerosal, and over to the right hand side is a fish. The 
greatest exposure to mercury of the American population comes 
from the amalgams in their mouths. This has been clearly 
established. The mercury amalgams in your mouth, the so-called 
silver fillings, contain 48 to 50 percent of elemental mercury. 
These fillings continuously emit mercury vapor which will go to 
the brain and is converted to mercuric mercury, as is pointed 
out there.
    On the far right-hand side, you'll see a picture of a fish. 
Certain fish contain methylmercury; again, very rapidly taken 
up from the GI tract, transported quickly to the brain, and 
converted very slowly to mercuric mercury. And then on the 
bottom left-hand side, you'll see thimerosal, which again will 
be taken up by the brain and quickly converted to mercuric 
mercury.
    Now, one of the findings of the recent National Academy of 
Sciences report is that you really cannot consider any form of 
mercury alone. Let me just read you the one statement from the 
prepublication form of this report. It says: Prospective data 
on all sources of mercury exposure such as vaccines and dental 
amalgams and dietary intakes of methylmercury are essential to 
understanding the effects of environmental mercury exposure on 
any outcomes.
    May I have the next slide, please? This will show you the 
target organs of various forms of mercury: mercury vapor of the 
brain, methylmercury of the brain, thimerosal of the brain, and 
mercuric mercury if it's taken up from outside of the body, the 
kidney. What's important to find out is all three of the first 
three forms are neurotoxic, neurotoxic in particular in the 
brain. By neurotoxic, we mean it will damage nerves and it will 
damage brain tissues.
    The next slide, please. Neurotoxicity of mercury. I think 
the first statement is that the mercury stays in the brain. I 
can't quite see the slide myself from here. The mercury remains 
in the brain. My colleague, Mary Aposhian, has looked for the 
last 10 years for compounds that would bring mercury out of the 
brain. There is no such therapeutic agent that we know of. Most 
of the research in this country, as far as getting mercury out 
of the brain, is supported by the family of a former Vice 
President of the United States. It is believed that that Vice 
President died of mercury toxicity. That family has done more 
for studying basic mercury toxicity than probably any other 
foundation or government in our country.
    The most sensitive organs: brain of fetus, brain of 
children, brain of adults. Again, the brain of the fetus is 
uniquely susceptible to mercury toxicity, as are the brains of 
children and the brains of adults. We're mature. What I would 
like you to remember is a child is not a small adult. The 
metabolism, the biology of the child, is quite different. The 
child has developing organs. The fetus has developing organs. 
And we know that mercury will stunt certain metabolic reactions 
involved in development.
    The next slide, please. The final slide points out that 
which damages the brain. Again, the recent National Academy of 
Science report really introduced something quite novel as far 
as the thinking of the scientific community. And that is, as 
you look at all this--these slides, the central compound, the 
central form of mercury here is mercuric mercury. Mercuric 
mercury vapor converts into mercuric mercury, thimerosal 
converts to mercuric mercury, as does methylmercury. So this is 
probably the culprit, mercuric mercury. The report points out 
that we must consider methylmercury and mercuric mercury as 
well as thimerosal in order to understand the neurotoxicity of 
mercury.
    Let me just say as a final statement that there is no need 
to have thimerosal in a vaccine. There are other agents that 
can be used that are known to be safe.
    Thank you for your attention.
    Mr. Burton. Thank you, Doctor.
    [The prepared statement of Mr. Aposhian follows:]
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    Mr. Burton. Dr. Humiston.
    Dr. Humiston. Mr. Chairman and members of the committee, I 
applaud your efforts to bring parents, scientists, and 
policymakers together around the issue of autism. I am grateful 
for the opportunity to share my perspective as a parent, 
pediatrician, and public health researcher.
    Last week, my baby Quinn demonstrated developmental skills 
that thrilled my husband and me. He pulled his father's hand 
toward a pile of rocks, used his other hand to point toward a 
puddle, and said, ``dad ock bla-bla,'' which meant, ``Daddy, 
throw this rock in the water.'' Unfortunately, Quinny is 7\1/2\ 
years old.
    The worst day of my life was not the day the developmental 
pediatrician told me, almost apologetically, that my son was 
autistic. The worst day came later when the specialists told me 
that Quinn's progress was minimal after a year and a half of 
intense therapy, and that this made his prognosis grave. My 
family's response was very typical. We reached out and embraced 
a succession of therapies, each touted as a lifesaver. We heard 
that gluten allergy was the cause, and we changed Quinn's diet. 
Later we tried, for example, a phenol-free diet, megavitamins, 
anti-yeast medications, and cranio-sacral massage. Each therapy 
was supposed to get at the cause of Quinn's autism. Each 
therapy was expensive, and each for my son was a failure.
    You may wonder what would make a reasonable person pursue 
such an array of untested and unproven approaches. Well, I am a 
desperate mother. I am desperate to help my son quickly during 
his early years when we'd expect rapid brain development. I am 
desperate because the science lags so far behind my son's 
needs. My family has been blown by every wind, every theory, to 
explain this pervasive developmental disorder, and we are 
tired. We are physically tired, financially tired, emotionally 
tired. So I am here today to encourage you to nurture the 
science that will help, if not my son, then at least my little 
girl's future children.
    Funding, of course, is a very good way to show support. I 
appreciate the significant increases in NIH funding for autism 
research. I am grateful for CDC's investment in vaccine 
research. Generous and sustained funding for short-term and 
long-term studies is the most powerful help the government can 
offer my family. Please do more.
    I have also a list of please don'ts. Please don't 
overemphasize the investigation of some factors because they 
seem so risky, while ignoring other potentially important 
factors. We know, for example, that because vaccination is 
unpleasantly memorable, we tend to perceive it as riskier than, 
say, exposure to mercury in fish, which is not very memorable. 
Please don't exhaust your investigation on the mercury in 
vaccines and ignore the subtler and potentially more 
significant sources of neurotoxicants. Please don't ignore 
factors because they are complex or seemingly unalterable. I 
would prefer answers that are correct to answers that are quick 
and expedient.
    Please don't imagine that shaking public confidence in 
vaccines won't lead to the death of some children. We know that 
previous pronouncements on thimerosal led some U.S. birthing 
centers to discontinue the use of hepatitis B vaccine and this 
in turn led to cases of chronic infection in newborns. These 
babies have had about a 9 percent chance of going on to die of 
liver cancer or cirrhosis, neither of which are enviable 
deaths.
    We know that in the UK and Japan, pertussis vaccines scares 
led to decreases in vaccination and consequent increases in 
whooping cough, a disease that wracks a baby's body. We cannot 
forget that just 10 years ago, we saw a measles epidemic in 
this country that killed 123 children. That's not theoretical. 
We can count the death certificates. Though Hib disease 
essentially vanished once the vaccine was out, I will never 
forget it--fathers carrying limp, lethargic toddlers into the 
emergency department. Your actions have consequences. Please 
don't forget.
    Please don't miss the opportunity to study the results of 
removing thimerosal from vaccines. As the manufacturers change 
to mercury-free formulations, I hope someone is doing a 
definitive study to see if autism rates plummet.
    And finally, please don't ever frame this as a battle of 
parents against scientists. Generating hypotheses is a first 
step to finding causes and cures, and this committee has heard 
many conflicting hypotheses. The next step, testing these 
hypotheses, is painfully slow and costly, but I hope you will 
commit yourself to this scientific process. I believe it holds 
the greatest hope for my son and the many children like him. 
Thank you.
    [The prepared statement of Dr. Humiston follows:]
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    Mr. Burton. Thank you for your comments. I'd just like to 
say at the outset that nothing that this committee has ever 
said would indicate, at least from the Chair, that we are 
opposed to vaccines. We are very much in favor of vaccinations. 
What we are concerned about is whether or not the contents of 
those vaccinations are safe and whether or not they're being 
properly followed and looked into by the agencies of 
jurisdiction, the FDA and the CDC. And we're also very 
concerned about whether or not there are conflicts of interest 
between the people on the advisory panels that are making 
recommendations to FDA and the CDC and the pharmaceutical 
manufacturers.
    I'd like to ask you, Dr.--how do you pronounce your name--
Aposhian. They started using thimerosal in 1930.
    Mr. Aposhian. About that time.
    Mr. Burton. I was just wondering, I know this is pure 
speculation, we have a tremendous increase in Alzheimer's and, 
because of the neurological problems that many people are 
seeing from thimerosal being used in the vaccinations, where 
this could be a contributing factor in the Alzheimer's 
increase.
    Mr. Aposhian. There are some scientific papers that 
speculate about that. But at the present time, it cannot be 
said that Alzheimer's disease has been caused by mercury.
    Mr. Burton. You think that, along with the aluminum and 
formaldehyde and other things that have been in vaccinations 
for a long time, should be looked into by the health agencies 
as possible contributing factors?
    Mr. Aposhian. There's no question that mercury does not 
belong in vaccines. There are other compounds that could be 
used as preservatives. And everything we know about childhood 
susceptibility, neurotoxicity of mercury at the fetus and at 
the infant level, points out that we should not have these 
fetuses and infants exposed to mercury. There's no need of it 
in the vaccines.
    I think the Academy of Pediatrics has also quite firmly 
stated there is no need of thimerosal in vaccines.
    Mr. Burton. Why--and this is a question for any of you--why 
was thimerosal put in vaccines in the first place? Does anybody 
know? Why did they put that in there? It was supposed to be a 
preservative. As I read the statements that you made today, it 
was supposed to be something that kept bacteria out of the 
vaccinations, out of the vaccines.
    Mr. Aposhian. That's correct, sir.
    Mr. Burton. And yet the information that I see here is that 
it really doesn't.
    Mr. Aposhian. In the early thirties, in fact the 1940's and 
up until the mid-1950s, mercurials were used in medicine. They 
were used as diuretic agents. The medical community had no 
evidence--had nothing better to use. They had nothing better to 
use as a preservative at that time than thimerosal. And I would 
venture the opinion that it has just been going on because no 
one has objected to it. And there's no need for it any longer. 
And I don't know any medical community or scientific community 
that would agree to the need for having thimerosal in any 
vaccine.
    Mr. Burton. Dr. Enayati said in his statement in 1982, 18 
years ago--and it's in the Federal Register--an FDA panel 
concluded that thimerosal is toxic, causes cell damage, can 
cause allergic reactions, and is not effective in killing 
bacteria or halting their replication.
    That was 18 years ago. Why, if we knew that 18 years ago, 
did they continue to let that be put into these vaccines? Does 
anybody know the answer to that?
    Mr. Aposhian. I think that's what you should ask the FDA 
representative.
    Mr. Burton. Oh, I plan to. Now, the hepatitis B vaccine has 
thimerosal in it, and that's given to infants. As I understand 
it, infants don't really have a great deal of exposure to 
hepatitis B because it's--you can contract it through blood, 
through sex, or through, I guess, needles. Unless the parent 
has it. So why are we giving hepatitis B vaccines to infants? 
Does anybody know that? Unless the parent has it. Would you 
like to comment, Dr. Humiston? I see you started to move 
forward.
    Dr. Cave. One of the main areas that we need it is when we 
have a mother who tests positive for hepatitis B.
    Mr. Burton. I understand that. Aside from that, why the 
need to have it?
    Dr. Cave. I agree with you. I don't find the need for it on 
the day of birth in children who don't have mothers who are 
positive.
    Mr. Burton. OK. Doctor.
    Dr. Humiston. The day of birth is different than some time 
during infancy. We know that in 1990, before universal 
vaccination with hepatitis B, that by age 10 there were 19,000 
children in the United States that had contracted hepatitis B, 
even though their mothers were hepatitis B surface antigen 
negative. So they have--it's possible to have exposure to 
hepatitis B in ways other than perinatally. It's a small number 
overall. You know, if you look at the entire population of the 
United States less than 10 years of age, but 19,000--and, of 
course, when you are exposed to hepatitis B during your early 
life, you're more likely to go on and be a chronic carrier.
    Mr. Burton. Have there been studies--and I'll yield to 
Danny--or, excuse me, to Mr. Davis in just a minute--but have 
there been studies showing the various ages at which children 
contract hepatitis B? Because it seems to me inconceivable 
before the age of 6, or 5, that children would really have much 
exposure to it. I mean, you said below age 10. How about the 
various age increments? You don't know?
    Dr. Humiston. I don't know how it's divided out.
    Mr. Burton. Could we check that out and find out what ages 
we start to see----
    Dr. Cave. It's very rare if the mother is not hepatitis B-
positive that an infant shows hepatitis B.
    Mr. Burton. Up until what age, you say 5 or 6?
    Dr. Cave. I think it's far beyond that.
    Mr. Burton. Mr. Davis, you're recognized.
    Mr. Davis of Illinois. Thank you very much, Mr. Chairman. I 
missed a part of the testimony from some of the witnesses, but 
that which I heard I found to be quite intriguing.
    Dr. Aposhian, how long has the scientific community been 
aware of the alternatives to the use of mercury?
    Mr. Aposhian. Sir, it depends how you define the scientific 
community. The academic community, I would say since 1955, has 
been concerned about the use of mercurials in medicine. The use 
of mercurials in medicine has had a long history. It used to be 
used as a treatment of syphilis. It used to be used for the 
treatment of many, many infectious diseases before we had 
antibiotics.
    Mr. Davis of Illinois. I know that there's often resistance 
to change, even when something comes along that we can assume 
or we might even know to perhaps be more effective, more 
efficient, less dangerous, less costly or whatever. Can you 
think of any reasons why, if we are aware of the alternatives 
and if they are safer, why we have not moved assiduously in 
that direction?
    Mr. Aposhian. Congressman Davis, there are three groups 
involved here, I think. We have an academic group, we have a 
government group, and we have an industrial or pharmaceutical 
group. Because of our society, most industrial groups, most 
pharmaceutical companies, are very reluctant to change anything 
because of the tremendous cost of getting that change through 
the FDA. And the other concern by pharmaceutical companies is 
just how dangerous is dangerous? And that, I think, is where 
the greatest argument comes in and that's where the FDA should 
be acting as a judge.
    Dr. Humiston. I don't mean to be cynical about the 
pharmaceutical companies, but I don't think that they're going 
to take to moving toward thimerosal-free vaccines, I don't 
think they will be taking financial losses, because one of the 
things that happens is we won't be able to have vaccines in 
multidose vials. Multidose vials are much less expensive than 
single-dose vials. So going to all single-dose vials will 
actually bring more profits to the pharmaceutical companies. 
And I don't--you know, I am not saying that that's their 
motive, I'm simply saying that they have nothing to lose.
    Mr. Davis of Illinois. But it is in fact, I guess, 
sometimes difficult to feel that certain kinds of self-
interests don't creep into the ultimacy of decisionmaking. And 
I guess that's where it takes----
    Dr. Humiston. Again I don't mean to be cynical, but I think 
that the pharmaceutical companies have moved quite quickly, and 
partly, probably, because they don't have a great deal to lose.
    Mr. Davis of Illinois. I guess what you're saying is no 
matter how you cut it, you can't get around the whole concept 
of ultimate involvement of all of us in arriving at public 
policy, and that if there is enough action and activity, then 
one part balances out or one side balances out the other and we 
arrive at the public interest.
    I assume--I also listened to your testimony in terms of 
your own personal experience, and I was obviously moved, as 
anybody would be by it. Given your own training as well as the 
experiences, do you feel or would you have reason to believe 
that there might be any connection between immunization and 
autism?
    Dr. Humiston. What Mr. Davis is referring to is that I was 
formerly with the National Immunization Program. Now I'm a 
pediatrician at the University of Rochester. I have to say that 
I try very hard to keep an open mind scientifically, and I 
think that that is the most important stance that we can take 
now. What I am advocating for is good science. And again, I was 
present during the ACIP meeting, the Advisory Committee on 
Immunization Practices. I was happy to see that the science is 
going forward quickly. I hope that the science can go forward 
quickly. We've--this committee has heard other theories as 
well. And I hope that we come to better understanding--also the 
genetics. I mean, there's so many factors here. I think that 
immunization is just a tiny part, but it sticks in our mind 
because it's so memorable.
    Mr. Davis of Illinois. I thank you very much. Plus, Mr. 
Chairman, I must say I was pleased to hear your comment in 
terms of the position of the committee relative to the fact 
that there are no conclusions having been determined or 
reached, but what the committee is really hoping to do is to 
try and probe as deeply, as widely as it can, to try and find 
out as much as we possibly can about the issue. And I 
appreciate that comment that you made.
    Mr. Burton. Thank you, Mr. Davis. Ms. Chenoweth.
    Mrs. Chenoweth-Hage. Thank you, Mr. Chairman. As a 
grandparent of an autistic child, I've been fascinated with 
your testimony. I want to thank all of you for the method of 
your delivery. I know it's difficult. In the last hearing I had 
difficulty even giving my own opening statement, and I'm not a 
patient, I'm a grandparent. But they're precious, precious 
little children. And my heart goes out to you. But also I thank 
you very much for your courage in being here today.
    I wanted to begin my questioning with a question to Dr. 
Cave. I've been fascinated with your treatment procedure. And 
your procedure involves nutritional repletion of cellular 
chemistry and normalization of gastrointestinal bacterial 
balance, dietary problems, restoration of liver detoxification 
systems. What do you think about chelation also as a treatment? 
Have you considered that?
    [The prepared statement of Hon. Helen Chenoweth-Hage 
follows:]
[GRAPHIC] [TIFF OMITTED] T2722.004

    Dr. Cave. We are using oral chelation with a sustained 
release DMSA. The DMSA is a drug approved by the FDA for lead 
intoxication in children. We've used a sustained release form 
which has given us a totally different picture. We're pulling 
on a 24-hour basis now, and we're seeing the metal come out. 
And the children are changing in the first week that we start 
treating.
    We have another layer of treatment in which we add 
alphallipoic acid which does take it to the central nervous 
system. When we start pulling it from the central nervous 
system, we get sentences and speech in children who have not 
spoken. It's been phenomenal.
    Mrs. Chenoweth-Hage. That was going to be my next question. 
Can you pull it from the central nervous system?
    Dr. Cave. Yes, we can.
    Mrs. Chenoweth-Hage. Is chelation the best method of doing 
that, have you found?
    Dr. Cave. It's the only method. You have to pull the metal 
with something that will hook on to the metal. And these have--
sulf-hydryl groups, which will hook on to mercury.
    Mrs. Chenoweth-Hage. Dr. Cave, I was also interested in 
knowing what your thoughts were about why some children are 
affected this way while others perhaps have a physiologic 
system that's developed to the point that the toxins don't 
reside in the brain. What happens there?
    Dr. Cave. We are measuring the detoxification systems in 
the children's livers and we're finding variability. In the 
children that we're seeing that are developmentally delayed, 
there is very little--they're not able to detoxify very well. 
There's very little ability. The normal child has a better 
system. And we can measure that. There are some genetic 
factors. We have some ideas about that, too. And we're looking 
at several lipoproteins; that's very early right now. But it 
can be explained--it can't be fully explained, but it can be 
partially explained at this point, and there are genetic 
factors for sure.
    Mrs. Chenoweth-Hage. I see. Mrs. Birt, I found it very 
interesting in your testimony that you testified to the fact 
that there were some questions back in 1988 and then finally--
about thimerosal--and then finally in 1997 they issued a final 
rule, the FDA did, that disallowed thimerosal or indicated that 
products containing thimerosal were neither effective and may 
not be safe for over-the-counter----
    Ms. Birt. Correct.
    Mrs. Chenoweth-Hage [continuing]. Treatments. And also in 
your testimony, you talked--you testified to the fact that the 
FDA asked the vaccine companies to give them information on 
this. And could you elaborate more on that? I found that 
section of your testimony fascinating.
    Ms. Birt. I think the problem is that the manufacturers 
aren't held accountable, so nobody is responsible in the 
ultimate product. It's like a big circle. It goes from the 
manufacturer to the FDA to the CDC to the public. But nowhere 
in there is anybody legally or financially accountable if 
there's a problem. And the way our society is geared is that 
profitability is the highest thing.
    And I think that in order for the vaccine manufacturers to 
make the product thimerosal-free, they had to change their 
methods of production. And this is only speculation--they may 
have known there was a problem earlier and just didn't want to 
say anything. Nobody knows that for sure.
    But I think this whole process of finding out the truth 
will lead us to the truth eventually. But I think the 
fundamental problem is that we don't have accountability in the 
system, so the people who have the most to lose really aren't 
protected, which is basically the job of the government, to 
protect people who are at risk. And that has not been done in 
this process.
    Mrs. Chenoweth-Hage. Mr. Chairman, I see my time is up. I 
just wish I had about 3 hours to engage with these witnesses. 
My congratulations to you and your staff for the outstanding 
information we've received.
    Mr. Burton. Thank you, Congresswoman Chenoweth. We'll have 
one more round, if you would like to ask some more. Mr. Gilman, 
Chairman Gilman.
    Mr. Gilman. Thank you, Mr. Chairman. I regret that I was 
tied up on the floor with legislation that we're involved in. 
And I want to thank you, Mr. Chairman and the committee, for 
conducting this series of hearings on vaccine safety, and I 
want to thank our panelists for coming to voice their concerns 
and to give us their information. As we examine the various 
additives that are present in vaccines, it's extremely 
important that we note the role that they play and what, if 
any, other compounds may be available to fulfill their roles as 
appropriate substitutes.
    Today's hearing focuses on thimerosal, the preservative 
that contains small amounts of mercury. And that's the first 
that I've been made aware of how mercury is part of these 
vaccine substances and what they can do to our youngsters. I've 
been informed that these preservatives are used to inhibit the 
growth of bacteria fungus that might contaminate a multidose 
vial of vaccine where a physician reenters the same vial 
several times to inoculate several children. Apparently, 
without preservatives, there is a risk that a vial of vaccine 
could become contaminated and a physician could inadvertently 
inject a living organism into a child. Since 1968, I've been 
informed preservatives have been required by law in multidose 
vials.
    Thimerosal has been used for more than 60 years in a 
variety of vaccines. The fact that it's been used that long, of 
course, does not attest to its safety. It's been effective as a 
preservative in very low doses and highly stable--it is highly 
stable throughout the shelf life of that vaccine, and works 
across a broad spectrum of microbial agents. As such, it's been 
considered the best preservative that was available. And while 
its value in keeping vaccines free of contamination has been 
unchallenged, serious questions have now arisen as to the 
possible side effects in infants from exposure to mercury, the 
mercury that's available in thimerosal.
    It's my understanding that aside from 60 years experience 
in the field, there has been little directly applicable data on 
this concern until very recently. CDC has now looked at the 
level of exposure to mercury of immunized infants in three HMOs 
versus the appearance of symptoms such as renal failure, a 
hallmark of mercury poisoning, and various neurological 
deficits, including autism. This data has indicated what there 
is no association between the amount of mercury an infant is 
exposed to from vaccines in the development of any neurologic 
or renal problem. And that's why it's so important we're 
examining this issue today.
    And another type of additive to vaccines is the adjuvant. 
Adjuvants in vaccines help boost the child's immune response to 
bacteria or virus that is a poor stimulant of its own accord. 
Adjuvants therefore provide the ability to decrease the amount 
of bacteria or virus needed in a vaccine and/or to decrease the 
number of doses needed in an immunization series. Aluminum 
salts, I've been informed, are the only licensed adjuvant in 
our Nation. They've been safely used in vaccines for a number 
of years.
    Today, taking testimony from our panelists who are before 
us now regarding adjuvants and additives in vaccines and 
alleged associations between these additives and various 
illnesses, is extremely important to us. We must be vigilant in 
matters of vaccine safety. We've just gone through extensive 
hearings on anthrax and trying to make certain that any 
utilization of anthrax by the military is not going to affect 
their well-being. At the same time, it's important we focus our 
attention on scientific evidence. We must be careful we don't 
jump to conclusions based on anecdotes and speculations, but 
that's why it's good you're here to present specific cases to 
us. We must not lose sight of the fact that vaccines have saved 
millions of people from debilitating and deadly diseases, but 
we don't want the vaccine itself to cause side effects that are 
just as deadly.
    The effect of needlessly scaring parents away from 
immunizing their children is a real concern, and that's why we 
must tread very carefully as we go through this maze of trying 
to find out just what has affected our children by the 
substances that are present in the vaccine.
    So again I thank Mr. Chairman, thank you for being here, 
and I want to thank our panelists who are here today to give us 
the benefit of their thinking.
    [The prepared statement of Hon. Benjamin A. Gilman 
follows:]
[GRAPHIC] [TIFF OMITTED] T2722.189

[GRAPHIC] [TIFF OMITTED] T2722.190

[GRAPHIC] [TIFF OMITTED] T2722.191

[GRAPHIC] [TIFF OMITTED] T2722.192

    Mr. Burton. Thank you, Chairman Gilman.
    Ms. Ros-Lehtinen.
    Ms. Ros-Lehtinen. Thank you so much, Mr. Burton, for this 
hearing and for your constant leadership on this terrible issue 
of autism. I don't have autistic children, but I have a very 
good friend who has, as you may remember, because I've spoken 
about them before in this committee, two autistic children. 
Because of them, these hearings are of great importance to me 
personally and to many constituents in my district. Due to my 
association with her and her family I have come to know so much 
about autism and how many families are affected and indeed 
devastated by this problem.
    I'm always delighted to go back home with all of your 
material--and I want to commend your staff for preparing such 
fine materials for us at each hearing--how happy the parents of 
autistic children are with the literature, and then when I have 
the meeting with the so-called experts, how alarmed they are 
with the papers.
    I find that there's a great disconnect in the scientific 
community about what parents have come to know and understand 
through their own research and through their own set of 
circumstance. And I hope that both sides come closer together 
because I know that I will have that same reaction when I come 
back to Miami this weekend; that parents will be very happy 
with this information and the experts won't.
    And we do have some very good centers for autism in south 
Florida. I don't know if there's a geographical connection, but 
certainly south Florida has been very impacted by the effects 
of autism. We have the Card Center at the University of Miami, 
Center for Autism and Related Disabilities, a great center, and 
the Dan Marino Institute in Broward County. So my community has 
been blessed with good information. Yet I find that scientists 
and many within the medical community, the people with whom I 
deal with, they are not satisfied with the information that we 
give them. I find that disturbing, because I would think that 
these experts would be happy to see others doing research and 
promising information.
    I wanted to followup with a view of the great information 
that was given to us today. You were saying that in one of the 
publications, I'm not sure which one, that mercury levels can 
be detected in urine, hair, and blood.
    I'm interested in knowing how many autistic children you 
believe have been tested for mercury levels? As I said. I have 
two children of my own, they're 14 and 13 now. I don't recall 
whether that was a normal set of tests, but whatever it was, it 
was at a normal range. Is testing for mercury something that is 
usually done by pediatricians? Do you think that that is 
something that they should be looking at? Would it involve a 
more intrusive examination than is already given to children? 
Are you advocating that parents should have their children 
tested for mercury levels?
    That's my first question. Let me just throw them all out 
and whoever wants to, answer. Also, chelation--is that how you 
say it? Chelation methods, do they come in pill form or a shot 
or liquid that the child swallows, and how many children have 
undergone this chelation therapy or method? Finally, what was 
it formulated originally to treat? I'm interested in 
understanding more about that therapy.
    Thank you, whoever would like to answer those questions 
about mercury testing and chelation therapy and address the 
disconnect between parents and so-called medical authorities.
    Dr. Cave. Mercury is not something that is usually tested, 
and we were not really taught to test hair samples or to give 
chelation doses and test urine samples. If you look at some of 
the material I've provided in the handout on the hair samples 
that I have, you cannot find mercury in these children. We find 
mercury in the hair of children who are receiving the vaccines, 
but these children are beyond the first dose of vaccine. So the 
mercury has moved beyond this level. It stays in hair only a 
certain period of time. It doesn't actually stay in blood.
    But when we give the dose of a chelator, it brings it into 
blood and then into the urine, and then we can measure it in 
urine. This is something that we started doing 4 or 5 years ago 
when we started treating the children. And I noticed that we 
were finding metals in the small children and in children who 
were receiving the--well, a vaccine like hepatitis B later on 
in life. I found it in the hair sample of a young man who had 
the hepatitis B series in college. He was left with severe 
depression, and his brother was left with seizure disorder. And 
I found it in the hair of both of these young men.
    But you have to be able to look for something. You have to 
know how to look for it in order to find it. When we were using 
the drug as it's given in the regular drugstore, without 
technology-sustained release, we were not even finding very 
much in the urine. Now that we're using a sustained release, 
we're bringing it out into the urine.
    If you notice on the handout that I have there, it's very 
high in the urine as submitted, even though it was negative in 
the hair. In the hair, we look for aluminum and we find 
aluminum and we find antimony in the hair. And we are treating 
that--we're not treating that with the same medication. We're 
using an over-the-counter to treat the aluminum and it's 
working well, with no toxicity that we can see.
    Mr. Burton. Anyone want to comment briefly on the chelation 
she was talking about, the various forms of chelation?
    Mr. Aposhian. Let me say that our laboratory for the last 
18 years has been the primary laboratory dealing with the use 
of DMSA, the development of DMSA, the approval of DMSA by the 
FDA. It's a chelating agent. That means it competes with other 
materials in the body for a particular metal or group of 
metals, makes that metal more soluble, and therefore excretes 
it.
    The controversy has always been, just because you get rid 
of a metal does not necessarily mean you improve the clinical 
position of--the clinical condition of the patient. This is 
always controversial.
    Chelation therapy is certainly not accepted by the vast 
majority of established medicine. It is accepted quite greatly 
by alternative medicine people. I think it's just a subject of 
controversy at the present time. There is no question at all 
that it helps children that have been exposed to lead. It gets 
rid of the lead and decreases their chances of getting any 
worse.
    The National Institutes of Environmental Health Sciences at 
the present time have a $35 million program to see whether 
giving DMSA to children who have been adversely affected by 
lead will improve their condition. As yet there is no solid 
information that their condition has been improved, but all the 
information is not present yet.
    Chelation therapy has always been a method of getting rid 
of toxic metals. There are various chelating agents that can be 
given by mouth, like DMSA. There are other ones that can be 
given by mouth or injection. And there are also very toxic 
ones. I also want to point out, the problem is that you can't 
take an autistic child, give him any kind of an agent, and then 
test his brain to see whether that particular toxic metal has 
been removed. We can do that in animal studies; we cannot do it 
in human studies, of course.
    Does that answer your question, Congresswoman?
    Ms. Ros-Lehtinen. Yes.
    Dr. Cave. But clinically they're improving. We're bringing 
them back 80 percent, 90 percent, in terms of social 
interaction with speech, with eye contact, and that's proof 
that the central nervous system is functioning at a higher 
level. We can't go in and biopsy the brain, but we can 
certainly look at the child.
    Mr. Burton. Mr. Cummings, you have questions?
    Well, we have a number of questions I would like to submit 
for the record to each one of you. You have been very, very 
informative in your statements and I really appreciate that. I 
would like to ask you a whole host of questions, but the hour 
is getting late, and I know we're going to have votes on the 
floor and we're going to be down there for awhile. So would you 
all be willing to answer questions for the record that we 
submit to you? We'll put those in the record as soon as we get 
them.
    I want to thank you all for being here. I hope you can stay 
around to hear the testimony from the agencies of the 
government. Thank you very much.
    We will now have panel No. 2. Ms. E. Ramona Trovato, 
Director of the Office of Children's Health Protection, 
Environmental Protection Agency; Dr. William Egan, Acting 
Office Director, Office of Vaccine Research and Review, the 
Center for Biologics Evaluation and Research; Dr. Roger H. 
Bernier, Associate Director for Science at the National 
Immunization Program, Centers for Disease Control and 
Prevention; and Dr. Marie Bristol-Power, National Institute of 
Health and Human Development, the National Institute of Health.
    Could I have you all stand so we could have you sworn, 
please?
    [Witnesses sworn.]
    Mr. Burton. Be seated. We'll start with Ms. Travato. Did I 
pronounce your name right?
    Ms. Trovato. You sure did. May I begin?
    Mr. Burton. Yes.

STATEMENTS OF E. RAMONA TROVATO, DIRECTOR, OFFICE OF CHILDREN'S 
 HEALTH PROTECTION, U.S. ENVIRONMENTAL PROTECTION AGENCY; DR. 
    WILLIAM EGAN, ACTING OFFICE DIRECTOR, OFFICE OF VACCINE 
   RESEARCH AND REVIEW, CENTER FOR BIOLOGICS EVALUATION AND 
RESEARCH [CBER], FDA; DR. ROGER H. BERNIER, ASSOCIATE DIRECTOR 
FOR SCIENCE, NATIONAL IMMUNIZATION PROGRAM, CENTERS FOR DISEASE 
 CONTROL AND PREVENTION; AND DR. MARIE BRISTOL-POWER, NATIONAL 
 INSTITUTE OF HEALTH AND HUMAN DEVELOPMENT, NATIONAL INSTITUTE 
                           OF HEALTH

    Ms. Trovato. Good afternoon. I am Ramona Trovato, Director 
of the Office of Children's Health Protection at the U.S. 
Environmental Protection Agency. I appreciate the opportunity 
to appear before you today to talk about the problem of 
mercury, particularly as it affects fetuses and very young 
children.
    Mr. Chairman, while I appreciate the primary interest of 
this committee today is the role that mercury may play in 
causing health effects in children when used as preservatives 
in vaccines, EPA does not have regulatory authority to address 
vaccines and their preservatives. EPA does have authority to 
address releases of mercury to our air, land, and water, and is 
actively addressing such releases through both regulatory and 
nonregulatory actions.
    Mercury is a naturally occurring metal which persists in 
the environment and has long been known to have toxic effects 
on the nervous systems of humans and wildlife. The most 
significant releases of mercury to the environment in the 
United States are man-made emissions to the atmosphere from 
combustion sources, including waste and fossil fuel combustion. 
Mercury from such emissions as well as naturally occurring 
mercury and mercury from past uses, such as in fungicides on 
crops, is deposited into the soil and water. Concentrations of 
mercury in air and water are usually low and of little direct 
health concern. Once mercury enters water, however, it may be 
converted to methylmercury which can then accumulate in fish 
and marine animal tissue. Methylmercury levels in fish at the 
top of the food chain are, an average, 7 million times higher 
than the concentrations of dissolved methylmercury found in the 
surrounding waters. As a result, human exposure to 
methylmercury occurs primarily through eating contaminated 
fish. The amount of methylmercury that people are exposed to 
depends on the species of fish consumed, the concentration of 
methylmercury in the fish, and how much and how often fish are 
consumed.
    While most U.S. consumers need not be concerned about their 
exposure to methylmercury, some exposures may be of concern. 
Those who frequently consume large amounts of fish or who eat 
fish from water contaminated with mercury may be more highly 
exposed. Populations such as pregnant women and their fetuses 
may be at risk if they consume large amounts of contaminated 
fish or fish with relatively high levels of methylmercury.
    Because the developing fetus is the most sensitive to the 
effects of methylmercury, women of childbearing age may be at 
particular risk. These women should pay attention to the fish 
advisories issued by their States that suggest limiting the 
consumption of fish containing higher levels of methylmercury.
    Methylmercury is toxic to adults, children, and the fetus 
but prenatal and postnatal exposure can adversely affect the 
nervous system. Dietary methylmercury is almost completely 
absorbed into the blood and distributed to all tissues, 
including the brain. It also readily passes through the 
placenta to the fetus and fetal brain. Effects on the fetal 
nervous system occur at lower exposures than do effects on the 
adult nervous system. Mercury interferes with the development 
and function of the central nervous system, with health 
consequences ranging from subtle to severe, depending on the 
amount and timing of exposure.
    In 1995, EPA published a reference dose of 0.1 micrograms 
per kilogram of body weight per day, based on the effects seen 
in children following methylmercury consumption by the mother 
during pregnancy.
    Just last week, the National Academy of Sciences released 
their findings on the health effects of methylmercury based on 
its evaluation of recent epidemiological studies. The NAS 
affirmed EPA's reference dose is a scientifically justifiable 
level for public health protection for the most sensitive 
subpopulation--mothers and their unborn fetuses. The NAS has 
also indicated that the majority of U.S. population has low 
risk of adverse effects from current methylmercury exposures. 
However, the NAS also estimated that more than 60,000 children 
are born each year at risk of adverse neurodevelopmental 
effects such as overall cognitive ability, language 
development, spatial perceptual skills, and motor skills due to 
in utero methylmercury exposure.
    EPA is taking action to reduce mercury in the environment. 
EPA has issued standards that limit air emissions of mercury. 
The agency has developed regulations for boilers, process 
heaters, solid waste combustors and chlor-alkali plants. The 
remaining largest identified source of mercury emissions are 
coal-fired utility boilers.
    In summary, it is clear that women of childbearing age 
should take steps to minimize their exposure to methylmercury 
from eating contaminated fish. People who regularly eat fish 
should be aware of any State fish advisories. Because of the 
beneficial effects of fish consumption, the long-term goal 
needs to be reduction of the concentration of methylmercury in 
fish rather than the replacement of fish in the diet by other 
foods. EPA will continue to take steps to further improve 
public health, especially to protect children and fetuses, our 
most susceptible population.
    Thank you very much, and I'll be happy to answer questions.
    Mr. Burton. Thank you, Ms. Trovato.
    [The prepared statement of Ms. Trovato follows:]
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    [GRAPHIC] [TIFF OMITTED] T2722.197
    
    Mr. Burton. Dr. Egan.
    Mr. Egan. Thank you, Mr. Chairman and members of the 
committee. I am William Egan, the Acting Director for FDA's 
Office of Vaccine Research and Review. I appreciate this 
opportunity to discuss additives in childhood vaccines. I will 
focus my current remarks on thimerosal. I ask that my full 
written statement be entered into the record.
    Mr. Burton. Without objection, so ordered.
    Mr. Egan. Let me say that I am sympathetic to the concerns 
of the parents expressed by the previous panel. FDA will 
continue to work with parents and other public health agencies 
to foster the research and data necessary to determine the 
causes, treatment and hopefully prevention of autism.
    Vaccines licensed by FDA have been protecting children in 
the United States from deadly infections for well over 50 years 
and have been credited for saving more lives and preventing 
more illnesses than any other medical treatment. The risk of 
childhood diseases from failure to vaccinate far outweighs 
exposure to thimerosal in vaccines. Prior to licensure each 
vaccine undergoes a thorough review, and FDA considers all 
vaccines currently available to be both safe and effective.
    Preservatives are added to vaccines to help minimize the 
consequences of inadvertent microbial contamination, and with 
certain exceptions the use of preservatives is required by 
regulation for all multidose formulations. Thimerosal is an 
effective preservative which has been used in vaccines and 
other products since the 1930's.
    Requirements for preservatives in multidose vaccine 
formulations exist in many countries, not just in the United 
States, and have arisen as a result of tragic experience when 
bacterially contaminated vaccines were inadvertently 
administered to children. While the use of thimerosal does not 
absolutely eliminate the possibility of bacterial 
contamination, it markedly reduces its likelihood.
    The FDA has been actively addressing the issue of 
thimerosal as a preservative in vaccines. A review of 
thimerosal by FDA and other Public Health Service agencies last 
year found no evidence of harm from its use in vaccines. 
Nevertheless, because of concerns about the potential exposure 
of infants to mercury from all sources, in July 1999 the Public 
Health Service, in concert with the American Academy of 
Pediatrics, urged vaccine manufacturers to reduce or eliminate 
thimerosal in vaccines. Much progress has been made to this end 
over this past year.
    Let me focus on the routine recommended immunizations given 
to children in their first 6 months of life. Last year at this 
time thimerosal was present in both of the licensed hepatitis B 
vaccines; in some, type B Haemophilus influenza, DTaP vaccine, 
and that is the vaccine for diptheria, tetanus and pertussis. 
Since last summer, thimerosal has been eliminated or reduced by 
more than 96 percent in the pediatric hepatitis B vaccines. 
With regard to the Haemophilus vaccines, Wyeth-Lederle has 
announced that they will be manufacturing only their 
thimerosal-free single-dose Haemophilus formulation. The other 
Haemophilus vaccines are already thimerosal-free as is a 
combination vaccine for Haemophilus and hepatitis B. All of the 
Haemophilus vaccines now being manufactured are thimerosal-
free.
    Let me now turn to the four DTaP vaccines. The DTaP vaccine 
from SmithKline Beecham does not contain thimerosal as a 
preservative, and both Wyeth-Lederle and Aventis Pasteur have 
announced that they will be submitting license supplements to 
FDA for thimerosal-reduced vaccines either this month, later 
this month, or in August. North American Vaccines has begun 
discussions with the agency on a thimerosal-free formulation. 
FDA is committed to the expedited review of these applications, 
and hopefully in early 2001 will have additional thimerosal-
reduced DTaP vaccines.
    Various Federal agencies, including FDA, the Environmental 
Protection Agency and the Agency for Toxic Substances and 
Disease Registry, have been addressing the health risks of 
mercury, particularly methyl mercury. Thimerosal is a 
derivative of ethyl mercury, a closely related compound. It is 
important to note that there are no convincing data or evidence 
of any harm caused by the level of exposure that some children 
may have encountered following the existing immunization 
schedule. FDA's Office of Vaccines continues to urge 
manufacturers to develop new vaccines without thimerosal as a 
preservative and to remove or reduce thimerosal content in 
existing license vaccines.
    Based in part on the substantial progress that has been 
made in the reduction of thimerosal for vaccines in this past 
year, the American Academy of Family Physicians, the American 
Academy of Pediatrics and the Public Health Service in 
consultation with its Advisory Committee on Immunization 
Practices recently reaffirmed its goal set last year to greatly 
reduce or remove thimerosal from vaccines as rapidly as 
possible. The group also stated that the risk of not 
vaccinating children with DTaP or the remaining HIB vaccine is 
believed to far outweigh the risk, if any, of the thimerosal in 
them.
    Childhood vaccines have been a success story. Without 
vaccinations, children would be at a high risk of contracting 
many serious preventable childhood diseases. It makes good 
sense to remove thimerosal from vaccines, and we are committed 
to that goal, and we are rapidly reaching that goal. While we 
are continuing to work to remove thimerosal from childhood 
vaccines, we need to do this safely.
    Thank you for the opportunity to testify, and I will be 
glad to answer any questions.
    [The prepared statement of Mr. Egan follows:]
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    Mr. Burton. We have some votes on the floor. How many votes 
are there? Three. We have three votes on the floor, and I 
really apologize, but we will probably have to run down there 
for those votes. Rather than have you start your testimony, Dr. 
Bernier, I think we will go ahead and recess now, and we will 
be back in 25 minutes. We stand in recess.
    [Recess.]
    Mr. Burton. If we can get the doors closed, please, and get 
everyone to return to the hearing. I apologize for being away 
for so long.
    Dr. Bernier.
    Dr. Bernier. Good afternoon, Mr. Chairman and members of 
the committee. I am Dr. Roger Bernier, Associate Director for 
Science of the National Immunization Program at the Centers in 
Disease Control and Prevention.
    In opening, I would like to emphasize that we in the 
National Immunization Program have deep empathy for all of the 
parents who have experienced the devastating disorder that is 
autism. It is impossible for us who have devoted their lives to 
the health and well-being of children not to be affected and 
touched by the personal stories and hardships that lie behind 
every child and family affected by autism.
    Because of their enormous contributions to the health and 
well-being of children, vaccines have been frequently cited as 
one of the greatest public health achievements in the 20th 
century. The introduction and widespread use of vaccines have 
prevented millions of cases of childhood diseases and millions 
of premature deaths. Thanks to vaccines, there are few visible 
reminders of how serious and deadly vaccine-preventable 
diseases can be. The graphic impact of pertussis, another 
disease that was quite prevalent prior to the development and 
use of an effective vaccine, is detailed in my written 
testimony, and I would like if my written testimony can be part 
of the record.
    As a world leader in the licensing of new vaccines, the 
United States places a high priority on safety and efficacy. 
The steps that we have taken with respect to thimerosal 
illustrate how much we value vaccine safety. The Public Health 
Service in collaboration with the American Academy of 
Pediatrics and the American Academy of Family Physicians set a 
goal for the removal or significant reduction of thimerosal as 
a preservative for all vaccines routinely administered to 
children in the first year of life. We took this action even 
though there was no scientific data showing such exposure 
caused any harm.
    The risk of harm from thimerosal in vaccines remains 
largely theoretical. However, because it is feasible to produce 
vaccines that don't need thimerosal-based preservatives, we set 
the goal of moving as swiftly as possible to a thimerosal-
preservative-free childhood immunization schedule while 
ensuring that children continue to receive the immunizations 
necessary to prevent disease. Since last June we have made 
significant progress toward achieving that goal. Six of the 
seven vaccines recommended for routine use do not contain 
thimerosal as a preservative, including the four vaccines that 
never did. By early 2001 we expect to have an adequate 
thimerosal-preservative-free vaccine supply for all of the 
routinely recommended childhood vaccines.
    Since last July, the CDC has also undertaken a number of 
studies to understand the potential human health effects, if 
any, from exposure to thimerosal in vaccines. Using medical 
histories from the Vaccine Safety Datalink, investigators 
screened more than 100,000 children. They wanted to see if any 
statistical associations could be found between exposure to 
ethyl mercury in thimerosal-containing vaccines and those 
conditions most likely to be related to this type of exposure, 
that is kidney or neurologic conditions found in the medical 
records. The researchers looked at 17 different diagnostic 
codes. They found five inconclusive correlations between 
thimerosal exposure and the codes for language delays, speech 
delays, attention deficit disorder, unspecified developmental 
delays and tics. Importantly, however, this screening study did 
not find any evidence of any increased association between 
these conditions among premature infants, nor did it find any 
associations between thimerosal exposure and autism.
    An independent expert review of the screening study with 
the five inconclusive correlations was also undertaken. Twelve 
experts from outside the CDC evaluated the methods used and the 
results obtained. The consultants were unanimous in agreeing 
that the available evidence taken as a whole failed to meet the 
set of criteria necessary to establish that thimerosal caused 
the adverse health effects examined in these studies.
    We did not stop here, however. Good science involves trying 
to reproduce findings. We thus arranged to analyze information 
from another managed care organization to see if the five 
inconclusive correlations in the initial screening study could 
be duplicated in a similar yet completely separate data base. 
The second study found no statistically significant positive 
correlation between speech, language and attention deficit 
disorders and exposure to mercury from thimerosal-containing 
vaccines. The direction of the findings is reassuring as it 
does not confirm the earlier observations.
    To help us continue to address concerns about vaccine 
safety, CDC and NIH are contracting with the Institute of 
Medicine to establish a standing committee on vaccine safety. 
And I believe, Mr. Chairman, this is partly in response to the 
request that you had made with Congressman Waxman from the last 
hearing. There are steps very far along to move toward working 
with IOM to look at these vaccine safety concerns. This IOM 
committee will meet several times each year to assess any new 
evidence about possible adverse health effects from vaccines 
and to determine which vaccine safety concerns are a priority 
for further followup. The first issue we will seek to be taken 
up by the committee will be to review the available information 
about vaccines, including thimerosal and autism.
    Mr. Chairman, I recognize that a call for more research can 
be discouraging for parents with autistic children who feel 
that they cannot wait another day before doing something about 
this illness, but information which is not the right 
information only sends parents and families down the wrong 
paths. The history of science is replete with hypotheses and 
touted cures that have not panned out. If we hope to accurately 
identify and effectively address the causes of diseases and 
disorders, we must continue to trust the tools that have served 
us well, in this case the most rigorous scientific methods 
possible.
    In summary, I would like to reiterate three key points from 
my testimony. First, the introduction and widespread use in the 
United States of vaccines against many childhood diseases have 
prevented hundreds of millions of cases of disease and millions 
of deaths.
    Second, vaccine safety has been and is a high priority at 
the CDC and other Federal agencies. The vaccines produced and 
licensed in the United States meet the highest standards of 
safety and efficacy in the world.
    Third, there is currently no persuasive scientific evidence 
which establishes a causal link between vaccines and autism or 
vaccines and any neurodevelopmental outcome. It is imperative 
that children continue to receive all of the recommended 
vaccines in the most timely manner possible. Doing so will 
assure the greatest possible level of protection from the still 
circulating viruses and bacteria that cause serious and 
potentially deadly childhood diseases.
    Mr. Chairman, I would be happy to answer any further 
questions that you or the other Members may have.
    Mr. Burton. Thank you.
    [The prepared statement of Mr. Bernier follows:]
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    Mr. Burton. Dr. Bristol-Power.
    Ms. Bristol-Power. Mr. Chairman, members of the committee, 
I am Dr. Marie Bristol-Power, coordinator of the Network on the 
Neurobiology and Genetics of Autism at the National Institute 
of Child Health and Human Development at the NIH. I am pleased 
to address the committee on the topic on NIH autism research 
and vaccines.
    Autism is a complex disease, and a variety of influences, 
genetic, infectious, immunological, metabolic and possibly 
environmental, have been implicated as causes or triggers for 
autism. We believe that no single cause can account for all 
cases of autism, nor that any one treatment or cure will 
prevent or treat effectively all of its manifestations. Autism 
might be better understood as a class of disorders. Solving the 
puzzle of autism will be like peeling an onion, one layer at a 
time.
    Current consensus is that autism probably involves multiple 
genes interacting in some complex way that makes individuals 
susceptible to autism or autism spectrum disorders. The 
scientific challenge is to identify both the genetic basis 
underlying the disorder and the environmental influences that 
might precipitate autism in a genetically susceptible 
individual.
    Autism has two modes of presentation: One, the symptoms are 
apparent from birth. In the second the child apparently 
develops normally and then loses functional speech and 
socialization somewhere between 18 and 24 months of age. At 
this time there is no proven explanation for why children who 
develop normally lose speech and communication or speech and 
socialization. However, like the overall etiology of autism, 
there is likely to be a variety of causes for autistic 
regression.
    Recent reports both in the literature and testimony from 
this committee have raised the possibility of a link between 
autism and vaccinations, particularly the MMR vaccine, and 
between autism and vaccine additives. Since it is clear that 
vaccines are safe and effective for the vast majority of 
children, such reports raise the question of whether or not 
some children may suffer adverse events from vaccines which are 
helpful to the vast majority of children who receive them.
    The results of current study are inadequate to draw 
conclusions which would have far-reaching effects on children 
vaccination programs so important to the health of America's 
children. NIH is taking a number of different approaches to get 
information as soon as possible that will determine the merit 
of these recent concerns.
    In addition to pursuing our ongoing research on a variety 
of different causes for autism, NICHD, with cofunding from the 
CDC, is beginning a study of regression in autism. A thousand 
persons with autism will be evaluated through the Network on 
the Neurobiology and Genetics of Autism of the Collaborative 
Programs of Excellence in Autism which are supported by Child 
Health and the Institute on Deafness and Other Communication 
Disorders. We will identify a number of--200 children with 
documented regressive autism, and they will be compared with 
matched groups of children with early onset autism and with 
normally developing children. We will then compare across these 
groups early onset autism, regressive autism, and normal 
development; the presence, absence, duration of normal 
development; age of regression; vaccination history of children 
and of mothers over the course of the pregnancy; measles 
antibody levels and any association of vaccine additives and 
autism. The assessments will be done independently with blind 
assessments, and we will reexamine the hypotheses raised by 
investigators such as Drs. Singh, Wakefield and O'Leary. No one 
study can be definitive.
    Recent work by CDC is important and informative. We are 
also eagerly awaiting reports from the American Academy of 
Pediatrics and a report from the group founded by the National 
Academy of Sciences and the National Institute of Medicine, 
which is important because it will be an ongoing committee. 
This retrospective research and the reviews will provide 
valuable information. However, what is really needed is a 
prospective longitudinal study that will follow a minimum of 
100,000 to 150,000 children and youth from pregnancy through at 
least 21 years of age so we can find out what the interaction 
of genes and environment are that result in autism.
    We stand ready to work with you, with Congress, with parent 
advocacy groups, scientists and individual families so that no 
stone is left unturned for us to uncover the causes of autism, 
including the causes of autistic regression.
    I am pleased to answer any questions you might have.
    Mr. Burton. Thank you.
    [The prepared statement of Ms. Bristol-Power follows:]
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    Mr. Burton. Would you put that slide up there, please.
    I don't know if you can see that slide or not, but it shows 
the growth of autism in America, and if you can look at that 
real closely, you will see that in the 1940's up through the 
1970's, there was a gradual growth, and then it started to 
climb. The HIV vaccine was introduced in the late 1980's, and 
the hepatitis B vaccine was introduced, and we used to have 
somewhere between 1 child in 2,000 was autistic, and now it is 
close to 1 in 150. Some people would say that is darn near an 
epidemic.
    What I would like to ask is if this thimerosal is not a 
problem, why are you phasing it out of the vaccines?
    Mr. Egan. Although I am not aware of any convincing data on 
harm from the thimerosal that is in vaccines----
    Mr. Burton. Mercury.
    Mr. Egan [continuing]. From mercury in vaccines, we are 
nonetheless committed to removing mercury, all sources of 
mercury, from children. And we are also concerned about 
potential risks and I guess some of the data that are making 
people more concerned in recent years about the effect of low 
levels of mercury.
    Mr. Burton. My grandson in 1 day got 62 times what was an 
acceptable level. In 1 day.
    Let me ask you about this quote. In 1982, 18 years ago, as 
detailed in the Federal Register, and you can look this up, 
Federal Register volume No. 42, an FDA panel concluded that 
thimerosal is toxic, causes cell damage, can cause allergic 
reactions and is not effective in killing bacteria or halting 
their replication. That was 18 years ago, and yet you keep 
saying there is no conclusive evidence. Why is that?
    Mr. Egan. That report in the Federal Register was referring 
to the use of thimerosal, these organicmercurics, in topical 
materials.
    Mr. Burton. Not given internally?
    Mr. Egan. Like mercurochrome.
    Mr. Burton. It is bad on the outside, so you give it on the 
inside?
    Mr. Egan. In high concentrations. Yet it is effective as a 
preservative in biologics. It has continued to be used as a 
preservative in some of the eye drops.
    Mr. Burton. You know, one of the things that concerns me, 
Doctor, is that--you say that mercury in vaccines has not been 
proven to be a problem. How do you account for this dramatic 
rise? Do you think that is all genetics?
    Mr. Egan. I don't know the causes of the rise.
    Mr. Burton. You will admit it is a dramatic rise?
    Mr. Egan. It is dramatic, and I would agree with your 
assessment as epidemic.
    Mr. Burton. And mercury is a poison?
    Mr. Egan. Yes, it is. It is neurotoxic.
    Mr. Burton. And the FDA and the CDC are committed to 
phasing it out. Why not take it out today; 8,000 children are 
going to be immunized today. We understand that there is a 
supply for every child in America of nonmercury-oriented drugs. 
Why is it that we are not phasing it out today?
    Mr. Egan. There are a couple of things. If I can first 
address its use as a preservative, it is an effective 
preservative, and it is demonstrated to be an effective 
preservative. All of the preservatives that are used in 
vaccines are required to meet the USP definition of a 
preservative, meaning that the test article, the vaccine with 
the preservative in it, is taken. There are five challenge 
organisms that are added, there are three bacteria and two 
fungi, and these are added at 0.1 milliliter of each of the 
bacteria and fungi in a concentration between 100,000 and a 
million organisms, and within 14 days the preservative is 
required to reduce the bacterial count by 99.9 percent.
    Mr. Burton. Let me interrupt you there. As I understand it, 
if you take a vaccine that is a single vaccine, not a multiple 
vaccine, in one shot, that the preservative that you are 
talking about either isn't necessary, or you don't have to use 
something like mercury; is that correct?
    Mr. Egan. That's correct.
    Mr. Burton. It is a single shot.
    Mr. Enayati. A single-dose vial.
    Mr. Burton. Why don't we do that?
    Mr. Egan. That is primarily what is being done. Most of the 
changes that have been brought about since last summer have 
been the conversion of vaccines from multidose vials or even 
single-dose that did contain----
    Mr. Burton. If we have a supply on hand to take care of the 
needs of the American people and the children, why are we 
continuing to put mercury in their bodies? Why don't we stop 
now? Dr. Bernier.
    Dr. Bernier. I would like to try to answer that question, 
Mr. Chairman.
    Mr. Burton. Sure.
    Dr. Bernier. It is a good question, and it is one that we 
believe we would answer in the following way. We have set a 
goal to remove thimerosal from vaccines. We do not disagree 
with anyone who believes that this material should be taken out 
as rapidly as possible. We have set that goal. And I think we 
are pleased by the substantial progress that has been made and 
documented here today. Last year at this time a child could 
receive 187.5 micrograms of ethyl mercury from vaccines. Today 
that maximum is down to 75 micrograms. We have, since last 
summer, now reached a point where six of the seven vaccines are 
free of thimerosal as a preservative, and we believe the 
seventh one will be as soon as 6 to 9 months now, which is in 
early 2001.
    Mr. Burton. Seventy-five micrograms, 1.5 is considered 
safe.
    Dr. Bernier. I am not sure where you get that value, Mr. 
Chairman.
    Mr. Burton. For a 33-pound child, according to what we have 
found through our research, 1.5 micrograms is what is 
acceptable.
    Dr. Bernier. I need to emphasize that there is no data, 
there is no compelling evidence at this time of any harm that 
has come to any child from vaccines that contain thimerosal as 
a preservative.
    Mr. Burton. How do you account for that graph over there? 
Do you think that is a coincidence?
    Dr. Bernier. I would like to defer that to Dr. Bristol-
Power. I think this is a question about autism and the 
increasing rates of autism, and she is best qualified to 
comment on that.
    Mr. Burton. Let me make one more comment. Of the 11 members 
on the Advisory Committee on Immunization Practices, of the 11 
members, 6 of them have financial interests of one kind or 
another in the pharmaceutical companies that manufacture these 
vaccines. That doesn't look good to the public. Now, it may or 
may not be something that we should be concerned about, but it 
does concern a lot of people that we are keeping mercury that 
isn't necessary in vaccines when we have a supply that doesn't 
have to have those--that mercury in there. At the same time, 
the committee that is making the advisory panel that makes 
recommendations to CDC, over half of them have financial 
interests in the pharmaceutical companies. We checked for the 
past 10 years, and every one of the recommendations by the 
advisory panels has been accepted by FDA and CDC; so what they 
say is pretty much law. Now, how do you account for that?
    Dr. Bernier. I think there are several questions in your 
last statement. Let me tackle the issue about conflict of 
interest which I think you are raising.
    I am not responsible primarily for the management of that 
committee or have any direct responsibilities. The only thing I 
can say to you is, as I understand it, there are laws and 
regulations about who can serve on committees, and CDC is 
currently, as I understand it, following those procedures and 
has gotten a vote of confidence about how they are doing on 
that. I am not qualified to comment about that. In our society 
it is possible under the law to have conflicts of interest, and 
there are procedures for dealing with those.
    On the issue of whether or not we could move more quickly, 
we believe substantial progress has been made. We have set the 
goal, and we think that we have the right goal. We think that 
we have made substantial progress. If we were to move too 
precipitously, there would be consequences to pay. We know from 
the hepatitis B experience that occurred last summer that 
children fall through the cracks and that there is disease that 
is resulting as a consequence. So we don't want to move to this 
transition in a way that in some way jeopardizes the health of 
children, because we are confident that that will happen if we 
move too precipitously.
    So we are on the right course. We have made tremendous 
progress, and we are going to get there in the foreseeable 
future. We should stay the course.
    Mr. Burton. Ms. Chenoweth, and could you yield to me for 
about 10 seconds?
    Mrs. Chenoweth-Hage. Yes.
    Mr. Burton. Let me just say that 8,000 children are 
immunized today. You are phasing out thimerosal. You know there 
is a problem. You are not saying it, but you know there is a 
problem. You have a supply on hand that does not require having 
mercury in it, and yet you continue to use mercury, mercury-
oriented vaccines. It makes no sense. You have a supply to do 
it, and the FDA is not stopping this immediately, I submit, 
because there is a financial interest by a lot of 
pharmaceutical companies that have a large supply of this 
mercury-oriented vaccine still in stock.
    Mrs. Chenoweth-Hage. Thank you, Mr. Chairman, and I may ask 
you for a second and maybe a third round of questions. I have a 
lot of questions to ask these witnesses.
    I do want to open up my questioning by making a statement 
that I have a staffer who is in the Navy Reserve right now, but 
he used to be active with the airborne divisions, and he was in 
for a test in one of the medical military hospitals, and upon 
taking his temperature, they broke a thermometer, and mercury 
splattered across his glasses and some got in his eye. Well, 
the first thing they did was cutoff his clothes. The second 
thing was call in OSHA to clean up the mercury. And then they 
worked on him to make sure his eyes were irrigated, and you 
guys, you witnesses, absolutely amaze me. I wonder where the 
disconnect is, for Pete's sake.
    You listened to the testimony just as I did, and you are 
willing to, with a straight face, tell us that you are 
eventually going to phase this out after we know that a small 
baby's body is slammed with 62 times the amount of mercury that 
it is supposed to have, and OSHA reacts like they did in the 
case of this accident of this naval man. It doesn't make sense. 
No wonder people are losing faith in their government. And to 
have one of the witnesses tell us it is because mothers eat too 
much fish? Come on. We expect you to get real.
    We heard devastating testimony in this hearing today, and 
we heard it last April. And this is the kind of response we get 
from our government agencies?
    I am sorry.
    When I was a little girl, my daddy talked to me about 
something about a duck test. I would ask each one of you to 
read this very excellent work by Sallie Bernard and Albert 
Enayati, who testified here today. My daddy used to say if it 
walks like a duck and talks like a duck and sounds like a duck, 
for Pete's sake it is a duck.
    I recommend that you read this. Side by side, page after 
page of analysis of the symptoms of people who are affected 
with mercury poisoning compared to autism, this is the duck 
test, and you folks are trying to tell us that you can't take 
this off the market when 8,000 children are going to be 
injected tomorrow; 80 children may be coming down, beginning 
tomorrow, with autism? What if there was an E. coli scare? What 
if there was a problem with an automobile? The recall would be 
like that.
    We are asking you to do more than analyze it. We are asking 
you to tell this body and the American people that it is more 
inconclusive. It passes the duck test, and we need you to 
respond. We need that to come off the market now because you 
think that this is--do you think that we are elevating the case 
today? Just wait until it gets in the courts. This case could 
dwarf the tobacco case. And we would expect you to do something 
now before that circus starts taking place. Denial is not 
proper right now.
    I yield back the balance of my time, Mr. Chairman.
    Mr. Burton. Mr. Waxman.
    Mr. Waxman. Dr. Bristol-Power, you are an expert on autism, 
someone well versed on the literature of autism. Can you tell 
us your position on the possible connection between vaccines 
and autism?
    Ms. Bristol-Power. Based on the evidence right now, we are 
looking at any evidence linking vaccines and autism, 
particularly the MMR vaccine and autism and additives in 
autism. Some very serious concerns have been raised both in 
recent literature reports and in evidence and testimony before 
this committee. So we are beginning a study right now to look 
very seriously at whether or not there is a link that should 
be--that can be substantiated in a large group of 1,000 
patients with well-documented autism. We will be collecting 
behavioral measures and biological measures that will be tested 
in an independent laboratory that will reexamine the hypotheses 
that have been raised here. We are taking seriously the 
testimony of this committee and are reacting, we hope, with 
most haste to get answers to the questions that you have 
raised.
    Mr. Waxman. I think that is worthwhile because we want to 
make sure that we have checked everything out and evaluate 
whether this hypothesis is accurate or not that there is some 
connection, but up to now haven't you and other scientists 
looked at the connection between vaccines and autism, and have 
you found evidence to connect the two? Or are the reports 
accurate that say that autism might occur very early on in 
fetal development and that the connection appears because the 
time of autism manifesting itself in the child is pretty close 
to the time that immunizations are given?
    Ms. Bristol-Power. There are a couple of aspects. 
Historically, the vast majority of children have symptoms of 
autism from birth, so for that group certainly the later onset 
associated with any vaccines would not be compatible.
    We have a group of children that do regress that we know 
develop normally and lose speech and social interaction. At 
this point we don't have a satisfactory answer why they 
regress. But there are a variety of developmental disorders 
which are characterized by a period of normal development and 
regression. For example, there is a disorder called 
glutaricacidemia. It is a metabolic disorder. The children 
develop normally, and without treatment essentially it blows 
out their basal ganglia, and they become very disabled, and 
that is a metabolic cause.
    There are genetic disorders. Rett syndrome, those children 
develop normally, and then only gradually develop autistic 
characteristics. We now know there is a genetic basis for that. 
We have to be careful in assuming that because the onset is 
later, it necessarily is associated with something that 
happened later.
    Mr. Waxman. I appreciate that, but I want to ask another 
question of Dr. Bernier. On this issue of mercury, mercury is 
being taken out of vaccines, and I think that is a good thing 
because we should always err on the side of safety. The 
question that I would like to ask, and I am sure parents want 
to know, is this being done because there are known adverse 
related events or as a precautionary measure? CDC convened an 
expert panel to examine data that showed a possible weak link 
between thimerosal and certain developmental delays. The panel 
presented its findings to CDC's Advisory Committee on 
Immunization Practices and concluded that data were 
insufficient to show a causal connection between thimerosal and 
certain developmental delays. Is that true? Is that the 
position that CDC has taken?
    Dr. Bernier. That's correct, Mr. Waxman. At the present 
time CDC has no evidence of harm to any children from 
thimerosal in vaccines. We have constantly acted to look at the 
safety. Following the episode last summer, CDC did begin to 
look at the data in the Vaccine Safety Datalink, and one of the 
outcomes that we looked at was autism, and there was no 
suggestion of any association between thimerosal exposure and 
autism in the Vaccine Safety Datalink study.
    Mr. Waxman. Dr. Egan, is the FDA removing thimerosal from 
vaccines in response to evidence of actual harm or as a 
precautionary measure?
    Mr. Egan. It is done as a precautionary measure and to 
reduce mercury exposure from all sources, vaccines included.
    Mr. Waxman. I see my time has expired.
    Mr. Burton. You say that you are doing it as a 
precautionary measure. When did FDA and CDC first start being 
concerned about mercury in vaccines?
    Mr. Egan. I guess the major concern started somewhere 
around May 1999.
    Mr. Burton. May 1999. When you look back at the statement, 
and you were talking about a topical mercury a while ago, but 
in 1982, the FDA panel concluded that thimerosal is toxic, 
causes cell damage, can cause allergic reactions and is not 
effective in killing bacteria or halting their replication. If 
that was true for a topical mercury substance, why would you 
not be concerned about that if it was ingested?
    Mr. Egan. Those topicals refer to high concentrations.
    Mr. Burton. I understand, but we are talking about pretty 
high concentrations; are we not?
    Mr. Egan. I will have to look up and get back to you 
exactly what the concentrations were.
    Mr. Burton. I wish you would, because it doesn't say what 
the concentrations were. Like I said, we had testimony today 
from people that said that their children were getting 125 
times, 75 times what EPA and others say is--and CDC says is a 
safe amount of mercury into their bodies. If in 1982 you knew 
there was a problem and you didn't know the amounts for a 
topical, why would you continue to allow vaccinations to be 
given to children by the millions when there was a concern? I 
mean, I just don't understand. You say in 1999 you became 
concerned about it, but in 1982 in the Federal Register you had 
an FDA panel that said, hey, this is a problem. They said it is 
toxic. It causes cell damage and can cause allergic reactions. 
This was a topical. Why would you allow it to be inside a 
vaccination?
    Mr. Egan. It was allowed because it is effective as a 
preservative for those vaccines, and the dose was markedly 
reduced relative to those topicals.
    Mr. Burton. But you knew mercury was toxic, and there had 
been an FDA panel that said it was a problem, yet nobody over 
there said, we ought to take a look at this as far as 
vaccinations are concerned?
    Mr. Egan. I don't know. I don't know what people said.
    Mr. Burton. When this panel reached its conclusions and put 
it in the Federal Register, did anybody say, hey, if it is bad 
for the outside, why are we giving it to them on the inside? Or 
was maybe the pharmaceutical companies that made it as a 
preservative and it was in the vaccines saying that they had to 
keep it in there. Can you do some research and find out what 
happened during this timeframe? I can't imagine in 1982, 18 
years ago, realizing that this was a real problem, continuing 
to keep it in vaccinations.
    Mr. Egan. It was kept in other materials at that time as a 
preservative, not as an active ingredient.
    Mr. Burton. When did they start taking it out of over-the-
counter stuff?
    Mr. Egan. I will have to get back to you on all of those. I 
believe it is still in ophthalmics----
    Mr. Burton. Many of the over-the-counter----
    Mr. Egan [continuing]. As preservatives.
    Mr. Burton. Many of the over-the-counter drugs they have 
taken it out of at FDA request. In 1998, they said that it was 
no longer generally recognized as safe, and yet here we are 2 
years later, and you are phasing it out. You are phasing it 
out.
    This is the thing that Mr. Waxman and I may not agree, but 
I cannot understand, maybe you can explain, if there is any 
question about mercury in vaccine, if there is even a question, 
you are phasing it out because there is a question. You have a 
supply of all the vaccines that are necessary to immunize 
children of this country. You have that. You have them now. Why 
in the world are you continuing to immunize kids with something 
that is questionable? Give me an answer. I don't understand it.
    Mr. Egan. To date there is no--we have no evidence, 
convincing evidence, of harm from the thimerosal in vaccines.
    Mr. Burton. Doctor, I understand you have said that. The 
point is that you have a supply that you don't have to worry 
about, and you have a supply that you are phasing the mercury 
out of because there is concern. You don't agree that there is 
scientific evidence. If you are phasing it out, why in the 
world not use what you know to be safe so that the kids of this 
country can be safe?
    Mr. Waxman. Mr. Chairman, I ask unanimous consent that you 
be given an additional minute, because I think you have asked a 
key question. Why not take it off now?
    Dr. Bernier. I think a couple of things need to be pointed 
out. First of all, we have concerns about reliance on a single 
manufacturer. There are issues about whether or not that single 
manufacturer could gear up rapidly enough to move from being a 
partial provider of our national need to being the exclusive 
provider for the entire country. We have concerns about wether 
or not they can really do what they say they can do. That is 
No. 1.
    No. 2, we have concerns when we rely on a single 
manufacturer about problems that can occur in production, in 
meeting the requirements of the FDA. There have been episodes 
where there have been a fire in a plant. There have been 
episodes where there has been disruptions in the manufacture, 
and there have been shortages. So we have concerns that if we 
transition our vaccine supply too abruptly, we are taking a 
gamble. We are afraid we might lose and risk the health of 
children.
    There is also an issue about public policy, and we believe 
that whenever possible we should try to promote a situation 
where we have several manufacturers. In the long run that 
serves the interest of children best if we can have multiple 
producers of vaccines and not have to rely on a single one.
    So, Mr. Chairman, I think we are exaggerating the 
disagreement here this afternoon. We agree that we do not need 
to have thimerosal in vaccines. If it doesn't need to be there, 
we should take it out. And we should take it out as rapidly as 
possible. We have agreed to that. The Public Health Service, 
the vaccine manufacturers, and the academies are all in 
agreement. We have two, in my career, historic documents which 
are joint statements by the American Academy of Family 
Physicians, the American Academy of Pediatrics, and the Public 
Health Service, which includes NIH, FDA, HRSA and CDC all 
signing one statement. That is not easy to accomplish, believe 
me. We have all said that this material should come out as soon 
as possible. We don't disagree.
    There has been substantial progress made in just the last 
12 months for hepatitis B. As Dr. Egan has said, there are two 
vaccines that are free. There is no more hepatitis B with 
thimerosal for pediatric use. Children can have an entire 
supply free of thimerosal. For HIB, there are four vaccines. 
Three always were free, and now the fourth one is going to be 
free this month. So now we can say the entire supply of HIB 
vaccine is going to be thimerosal free.
    That leaves DTaP. There are four companies, one of which 
has already achieved thimerosal-free status. Three others are 
working on it. Two of them have told us publicly that they will 
have the supplements into Dr. Egan this summer, and we have 
gone on the record publicly stating this. We discussed this, 
during this last month. We put in writing that we anticipate 
that we are going to get there by early 2001. Some argued don't 
put the date in there. That will force us to be accountable in 
a way that we may regret, but people agree to do that because 
they agreed that it is a priority, and they saw the light at 
the end of the tunnel, and they were confident about it.
    In summary, No. 1, we agree with you that thimersol should 
come out. No. 2, it is coming out rapidly. And the third point 
is we have to do it in a way that we feel will not jeopardize 
the health of children, and we have seen their health 
jeopardized in the case of hepatitis B. We don't want to 
jeopardize their health this way.
    Some may think that is a gamble worth taking because there 
is not disease right now, but I can say this. When the three 
options were given at the ACIP meeting in June, the ACIP was 
not willing to take that gamble. The American Academy of Family 
Physicians would not take that gamble. NIH would not take that 
gamble. HRSA would not take that gamble. CDC would not take 
that gamble, and FDA would not. They all signed the joint 
statement.
    Mr. Burton. You have made your point.
    Mrs. Chenoweth, would you yield to me for just a minute?
    Mrs. Chenoweth-Hage. Yes, Mr. Chairman.
    Mr. Burton. The point is today you have a supply of vaccine 
that could be used to vaccinate every child in America that 
does not contain mercury.
    Now, the 8,000 children that are going to be vaccinated 
today, tomorrow and the next day are going to have mercury in 
the vaccine. Now, if you are wrong, if you are wrong, those 
kids could become autistic as a result of that. Like my 
grandson, they could become autistic and be ruined for life. 
And no matter how much hyperbole you use, if you have a safe 
supply of vaccine over here, why are you using the other?
    You said we only want to have one supplier. Well, you know, 
get the others up to speed as quickly as possible. You have a 
supply now. You have people supplying it now, and this 
hypothesis begs the question if you don't have a supply, then 
you still have a supply of the mercury-oriented vaccine as a 
backup if you have to use it, but why not use the safe stuff 
right now?
    Mrs. Chenoweth.
    Mrs. Chenoweth-Hage. Thank you, Mr. Chairman.
    You know, I still go back to the fact--I still want to talk 
about the duck test. Mr. Egan, I will address this to you. You 
know, it was shown in the last panel that autistic symptoms 
emerge after vaccination. It was shown that vaccines contain 
toxic doses of mercury. It was shown that autism and mercury 
poisoning, the physiological comparison is striking. There is 
altered neurotransmitter activity, abnormal brain neuronal 
organization, immune system disturbance, EEG abnormalities. It 
goes on and on and on, the comparisons. That is why I say, I 
back up what the chairman and the ranking member are all asking 
you, that we cannot wait until 2001 to have this pulled off.
    You know, if a jury were to look at this, the 
circumstantial evidence would be overwhelming. Let's do 
something before we see it in the courts.
    Mr. Egan, you stated it is very important to remember that 
safety margins are incorporated in all acceptable mercury 
exposure limits, right? Could you tell me what those exposure 
limits are for a 1-month-old, a 3-month-old, a 6-month-old, a 
9-month-old and a 1-year-old?
    Mr. Egan. Various government agencies have arrived at 
different guidelines for mercury exposure.
    Mrs. Chenoweth-Hage. I am asking you, representing your 
agency, Doctor. Can you tell me based on your testimony what 
those exposure limits are that you referred to for a 1-month, 
3-month, 9-month, 6-month and 1-year-old?
    Mr. Egan. Well, last summer when this was discussed within 
the Public Health Service, all of the agencies of the Public 
Health Service concurred on the ATSDR recommendation, 
guidelines, which is 0.3 micrograms of mercury per kilogram 
body weight per day.
    Mrs. Chenoweth-Hage. Well, would you provide that in detail 
to the committee in a report?
    Mr. Egan. Yes, I will, ma'am.
    Mrs. Chenoweth-Hage. How were those exposure limits arrived 
at? Could you also provide that in the report? I'd also like to 
know what the demographics of the population was that were 
tested. And could you forward that data to support your claim 
that you made in your testimony?
    Mr. Egan. Yes, ma'am.
    Mrs. Chenoweth-Hage. OK. And all the background data. What 
studies, Dr. Egan, were submitted to the FDA to prove that 
thimerosal was safe?
    Mr. Egan. When--OK. When thimerosal was, you know, was 
first used in vaccines in the--I guess starting around the 
1930's when vaccines were not regulated by FDA but by other 
organizations, there were some toxicology studies, you know, 
acute toxicology studies in animals and very, very limited 
amount of data in people that there was no acute toxic effect.
    Mrs. Chenoweth-Hage. And these were studies that were done 
in 1930, that were submitted to----
    Mr. Egan. They were also done in, I guess, the late 1920's 
and reported by researchers at Eli Lilly in 1930.
    Mrs. Chenoweth-Hage. OK. With regards to the induction of 
HIB vaccine and hepatitis B vaccine, could you advise the 
committee on what studies were done with regards to these new 
vaccines that would prove that thimerosal was safe? These were 
done, introduced, in the eighties and nineties.
    Mr. Egan. I believe it was in 1990. There was a long 
history of the use, safe use of thimerosal, you know, in 
vaccines since they were--since it was first introduced. And at 
that time, there was no data to suggest that the added mercury 
from the introduction of those new vaccines would be harmful.
    Mr. Burton. The gentlelady's time has expired. I'm sorry. 
Mr. Waxman.
    Mrs. Chenoweth-Hage. I do have other questions that I would 
like to submit in writing.
    Mr. Burton. Yes. We'll give you some questions we'd like 
for you to answer if you wouldn't mind after the hearing is 
over.
    Mr. Egan. Yes, sir.
    Mr. Burton. Mr. Waxman.
    Mr. Waxman. As I understand your testimony, you're not sure 
there's a problem from thimerosal, but you're taking the 
prudent course of getting it out of the vaccines. Dr. Bernier, 
as I understand your statement before in answer to the question 
why we're not taking it out of all vaccines immediately, you 
worry about the supply of vaccines that will be available, 
although the chairman made the statement that we have enough 
supply now to immunize every child in the country with vaccines 
without the thimerosal. Is that an accurate statement?
    Dr. Bernier. I would have to refer that to the 
manufacturer. We have been told publicly that yes, they do have 
an adequate supply of vaccine, but we're concerned--I wouldn't 
want to--I guess my first answer was perhaps a little too long; 
I didn't get to the second part. We have concerns about the 
supply. But the second thing is we have concerns about the harm 
that might come from an overly abrupt change. To answer the 
question it's a harm we believe is more real than the harm that 
we think would be associated with thimerosal.
    Mr. Waxman. What is that harm?
    Dr. Bernier. We know the harm from pertussis, we know the 
harm from hepatitis B. We know the harm from Haemophilus 
influenza B. We can, for example, just look at USA Today. Two 
days ago, there was this story of a mother who made a decision 
not to immunize her child against Haemophilus influenza B 
because it was a new vaccine. It sounded scary to her. And when 
asked by her pediatrician, should I take this Haemophilus B 
influenza vaccine, or do you want this Haemophilus B vaccine 
for your child, the mother made a decision ``no.'' The child is 
now deaf, the child has mental difficulties that requires 
Ritalin every day, and obviously this mother has deep regret 
about that. We believe----
    Mr. Waxman. I'm going to have to interrupt you because it 
sounds like you've answered the question and you're going on, 
but I only have a limited time. That would take up all my time.
    Dr. Bernier. I understand. I have that tendency.
    Mr. Waxman. I understand. I have the same tendency. But 
just so I can frame the issue: Nobody wants to have thimerosal, 
because it has mercury, in the vaccines, whether we think it 
does harm or whether we're sure it does harm or whether we just 
think maybe it does and let's be safe about it, so we ought to 
get it out of the vaccines as quickly as possible. But what I 
hear you saying is that if we move too precipitously, we might 
not have a full supply of all the immunizations available of 
all these illnesses that we know can be prevented, and we know 
we're going to get all these diseases back and we don't know, 
if we have the use of the vaccines that still have thimerosal 
in them, that there's ever going to be any harm for sure about 
the mercury. Is that your position?
    Dr. Bernier. That's right. We would be trading a harm that 
we know for one we don't know. We know the harm will come if 
children are not immunized, and we know that it happened just 
in the last 12 months. So we're facing a harm we know versus a 
theoretical harm--which at this time is still only theoretical 
from the best evidence that we have.
    Mr. Waxman. I think that's a good on-point statement, 
answer to my question. I think all of us would like to have 
this thimerosal out as quickly as possible. But on the other 
hand, I must agree with you. I don't want the supply upset, 
because I believe in immunizations, and I worry that people are 
going to be frightened because of the theory that has not yet 
been established of a connection to autism, that they might not 
get their kids vaccinated. We know for sure when that happens, 
we're going to get a whole long list of terrible diseases that 
I can feel as passionate about as anybody else.
    But the chairman showed a graph that showed an increase in 
autism. The chart showed a steep rise in the number of cases of 
autism. Ms. Bristol-Power, the chairman says there's a dramatic 
increase in autism, but some experts have told us that this 
could be due to better detection. I wonder if you have a view 
about that and if there really is an epidemic, a sudden 
increase, because Dr. Egan seemed to agree there was an 
epidemic, but you're the expert on whether there was.
    Mr. Egan. I'm sorry, but what I meant was apparently 
there's a very large number of cases.
    Mr. Waxman. Being detected.
    So my question, Dr. Bristol-Power: Are there more cases 
being detected because there's a dramatic increase in cases or 
better detection mechanism?
    Ms. Bristol-Power. We don't have the information to answer 
that question. We know that part of the increase is better 
diagnosis, more public awareness, and better services, frankly, 
so more children are being presented at service locations.
    In the United States right at the moment, we don't have 
adequate studies that would let us know about whether there is 
an increase in prevalence. We do know worldwide epidemiological 
studies show that--any studies done since 1987--there's about a 
double the rate of previous results from previous studies. But 
again it's not clear how much of that increase is from better 
diagnosis and greater public awareness, where these children 
have been diagnosed in other categories before.
    Mr. Waxman. Do you agree with that position, or do you 
agree with that position of Dr. Bristol-Power?
    Mr. Egan. Dr. Bristol-Power is the expert on autism, not I.
    Mr. Waxman. So you would have no disagreement with her.
    Mr. Egan. I would have absolutely no reason to disagree 
with her.
    Mr. Waxman. Thank you, Mr. Chairman.
    Mr. Burton. I think we're reaching the end of the hearing. 
I do have a couple final questions I'd like to ask here. How 
long will children continue to receive mercury vaccines if 
there's not a recall? How many years will they continue to 
receive those?
    You know, you mentioned the DTaP vaccination, but you have 
not mentioned the DPT vaccination which is still in use, which 
does use thimerosal. And the DPT shot, there's a lot of concern 
about that vaccination. That's why they went to the DTaP shot. 
Yet the FDA has not recalled the DTP vaccination and it's still 
being used. So how long will mercury vaccines containing 
mercury be used if there's no recall?
    Mr. Egan. For the routine immunization schedule that's 
recommended by ACIP and AIP, the recommendation is for DTaP.
    Mr. Burton. I know, but they still use the DTP shot. We had 
people from CDC and Health and Human Services testify that they 
still are using it. It's still being used.
    Mr. Egan. Again I'll have to get back to you on some of 
that. There have been some lots of DTP, primarily I believe 
Tetramune which is the DTP-HIB combination vaccine, but I 
believe that the few lots of that that have been released are 
for sale overseas.
    Mr. Burton. Well, in any event----
    Mr. Egan. It's not being used the United States.
    Mr. Burton. You're saying you don't believe there's use in 
this country?
    Mr. Egan. I'll have to check on it.
    Mr. Burton. But in any event, the question I'm asking is 
mercury containing vaccines, how long will they be in use if 
there's not a recall?
    Mr. Egan. Well, the majority of the vaccines, the 
Haemophilus vaccine and the hepatitis B vaccines are already 
thimerosal free. This has been accomplished since last summer.
    Mr. Burton. My question is--those vaccines that contain 
mercury, even though you're phasing it out. How long will they 
be used if you do not recall them?
    Mr. Egan. The--in their public statement, Pasteur and 
Wyeth, who are the other major manufacturers, two other major 
manufacturers of DTaP, said that they will be submitting 
supplements to their license for thimerosal-reduced vaccines 
either the end of July or the beginning of August.
    Mr. Burton. But the existing supply will be used until it 
runs out, and you don't know how long that would be?
    Mr. Egan. No. Perhaps my colleague from CDC can, you know, 
comment on the----
    Mr. Burton. I'd just like to know, because even though 
you're transferring over to vaccines containing no mercury, if 
there's a supply out there, if it's not recalled they're going 
to continue to be given to children. And that's a concern. Yes, 
sir.
    Dr. Bernier. May I try to answer that question? I don't 
think I can be definitive about it, because you're right that 
there is a pipeline, there is a supply, and it doesn't 
disappear overnight. But I think the handwriting is on the wall 
for vaccines that contain thimerosal in the United States, Mr. 
Chairman, I think we all agree with that. And as soon as the 
supply is considered adequate and secure, I believe you will 
find committees and others beginning to recommend many 
preferences for these vaccines. How quickly will all of this 
take place? The recommendation--it will depend on how the 
recommendation is stated. If you'll go back to the July 1999 
statement of--joint statement--it said that this goal was to be 
achieved as rapidly as possible. And we're now publicly on 
record as predicting that it will occur early next year. But--
--
    Mr. Burton. OK. This is my last question, and if Mr. Waxman 
has any questions he can ask them as well. The FDA seems to be 
saying that vaccines that were licensed from 1970 to the year 
2000 were not required to do testing on thimerosal. Is that 
correct? None of those--I mean, because thimerosal was used 
from the 1930's on, they really haven't done any testing since 
the seventies on whether or not there's a side effect from 
that; is that correct?
    Mr. Egan. I'm not sure if any--what test was or wasn't done 
on those specific vaccines, but I will get back to the 
committee on that.
    Mr. Burton. We'd like to know if there was any testing done 
on thimerosal. So anything you can give us on that we would 
appreciate.
    Henry, do you have any last questions? If not, I want to 
thank you very much for being here. We'll submit some more 
questions to you for the record.
    We appreciate you being here. We hope that you'll carry 
back to the agencies which you represent, the concerns of these 
parents that were here today regarding vaccines. We're for 
vaccinations, Henry and I agree on that, but we want to make 
sure they're completely tested and they're safe. Thanks a lot.
    [Whereupon, at 5 p.m., the committee was adjourned.]
    [Additional information submitted for the hearing record 
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