[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:]
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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:]
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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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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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