The following testimony was given at hearings held June 18, 2000 by the Committee on Government Reform,
Representative
Dan Burton, Chairman entitled
"Mercury in Medicine – Are We Taking Unnecessary Risks?
The testimony presented here consists of witnesses' prepared statements and are not
official transcripts of the proceedings. For a full accounting of the hearings,
please see http://www.house.gov/reform/hearings/healthcare/00.07.18/
Opening Statement
Dan Burton (R-IN)
Chairman, Government Reform Committee
“Mercury in Medicine – Are We Taking Unnecessary Risks?”
July 18, 2000
2154 Rayburn House Office Building
Washington, D.C.
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 from 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
conflicts-of-interest problems. They’re
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.
Today
we’re 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 of the Department of Education, that
doesn’t mean they’re anti-education. That
means they want our education 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 –two 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 even willing to ask the questions, then we have a real problem on our
hands.
I
believe that our primary focus in 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 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 would seem to many
to 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
would 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 six
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 one day. He may have been exposed
to 62.5 micrograms of mercury in one day through his vaccines. According to his weight, the maximum safe level of
mercury he should be exposed to in one day is 1.51 micrograms. This is forty-one 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 contained mercury from the market immediately. They did not.
On July 9, 1999, the American Academy of Pediatrics and
the United States Public Health Service issued a joint statement recommending the removal
of thimerosal from vaccines.[1] On May 31, 2000, the Food and Drug Administration
notified vaccine manufacturers that their review of mercury compounds in drugs and foods
concluded that reducing or eliminating thimerosal from vaccines is merited.[2] 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 eight thousand children in America may be given a toxic dose of mercury in their
vaccines.[3]
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[4]. 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 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. Vascken
Aposhian, University
of Arizona at Tuscon, one of the scientists who worked on this report. Ramona Trovato will
testify on behalf of the Environmental Protection Agency.
Section 413 of the Food and Drug Administration
Modernization Act of 1997[5]
required the FDA to compile a list of drugs and foods that contain intentionally
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 two years after
the date of its enactment on November 21, 1997. Dr.
William Egan will be testifying on behalf of the Food and Drug Administration.
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 (OTC) 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.” [6] On their own website, the FDA states, “lead,
cadmium, and mercury are examples of elements that are toxic when present at relatively
low levels.”[7]
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-Powers of the National Institutes of Health regarding the existing
research in autism. The characteristics of
autism and of mercury poisoning are strikingly similar.[8]
Dr.
Stephanie Cave, a physician from Baton Rouge, Louisiana 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 the 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, New Jersey. Lyn
Redwood of Tyrone, Georgia is a nurse practitioner, and Albert Enayati, of Paramus New
Jersey 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 eight
thousand children at risk.
The Record will remain
open until August 1, 2000.
[8] Table A, A Comparison of Mercury the Effects of Mercury
Poisoning and Autism, Autism: A Unique Type
of Mercury Poisoning, Sallie Bernard, Albert Enayati, B.S., Ch.E., M.S.M.E., Teresa
Binstock, Heidi Roger, Lyn Redwood, R.N., M.S.N., C.R.N.P., Woody McGinnis, M.D
Testimony of Lyndelle Horne Redwood
Before the Government Reform Committee
July 18, 2000
Mercury in Medicine. Are We Taking
Unnecessary Risks?
http://www.house.gov/reform/hearings/healthcare/00.07.18/redwood.htm
Chairman Burton, Congressman Waxman,
and Committee Members.
My name is Lyn Redwood. I
reside in Atlanta, Georgia 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’m a Nurse Practitioner. I also hold a Masters Degree in Community Health
Nursing and I’m a member of our County's Board of Health and local Planning
Commission.
My son Will weighed in at close to 9 lbs at birth. He was a happy
baby who ate and slept well, smiled, cooed, walked and talked, all by one year. Shortly after his first birthday he experienced
multiple infections, lost speech, eye contact, 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 have never 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% mercury. The report went on to say 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 a product safety sheet has been revised. Why were no such notices sent out informing us
that thimerosal preserved 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 had contained thimerosal. From
my research on mercury I have found it to be a potent human toxicant 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 0.1mcg per kilogram of body weight per day. At 2
months of age my son had received 62.5 mcg of mercury from 3 infant vaccines. According to EPA criteria, his allowable dose was
only 0.5mcg based on his weight. He had
received 125 times his allowable exposure on that one day. These large injected bolus exposures continued at
4, 6, 12 and 18 months to a total mercury exposure of 237.5 mcg. I also discovered that the injections that I
received during the first and third trimesters of my pregnancy and hours after the
delivery of my son to prevent RH blood incompatibility also contained mercury.
Knowing that the major effect of mercury compounds was neurotoxicity,
I questioned if these exposures could account for my son’s regression and disability. Since he was now 5 ½ years old, it would be
difficult 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 ppm mercury in his
hair. The allowable levels being less than 1
ppm. The EPA action level in hair is 1
ppm and 5 ppm is considered diagnostic for mercury toxicity. Since my son has never eaten fish or seafood nor
had dental amalgams, I have no other
identifiable source for his mercury levels outside of thimerosal exposure from his
vaccines and my RhoGAM injections.
Since last fall when I discovered my son’s mercury toxicity, I
have spent every free moment further investigating 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, I made phone calls, I wrote letters and actually went in person 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 this study were significant associations
between thimerosal exposure and ADD, tics, speech and language delay and
neuro-developmental delays in general. A
panel of experts who were convened to review the data 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 vaccine manufacturers
assured there was enough supply available to meet vaccine needs the first six months of
life. From the comments made by ACIP
committee members it was apparent that political and economic concerns for the vaccine
program took precedence over the health, safety and welfare of the children it is charged
to protect. One committee member even remarked that giving preference to thimerosal free
vaccines may result in reduced public confidence in vaccines. 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 only
exceed EPA guidelines the first six months of life. That is because the data was
inaccurately averaged over a six month time period. As any independent toxicologist will
tell you, mercury has a long half life and because of its inherent
pharmocokinetics, you
cannot legitimately calculate the effect of a bolus dose as if it were ingested in small
amounts over a longer period of time. To make a simple analogy, what the FDA is trying to
assert is that giving someone two tylenol a day for 60 days has the same effect of giving
them 120 tylenol all at once in one day! This, of course, defies common sense, much less
sound medical practice.
The truth is, vaccines, are
often the single largest source of mercury exposure postnatally in infants, but
nowhere in the mercury literature of EPA, FDA or 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 or 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 to no harm 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 there are bullets all over the floor.
Millions of children have been
needlessly exposed to toxic agents 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.
Vaccinal Ethylmercury and Neurologic Sequelae
Testimony by Dr. Albert Enayati,
Research Scientist in Medical Technology and Father of an Autistic Child
Founder of New Jersey Cure Autism Now
http://www.house.gov/reform/hearings/healthcare/00.07.18/enayati.pdf
Despite the fact that thimerosal preservative has been
effective in lowering the risk that vaccines could be
contaminated by bacteria leading to serious infection, the
United States Public Health Service agencies, including
NIH, FDA, HRSA, and CDC, working collaboratively with the
American Academy of Pediatrics and the American Academy of
Family Physicians, took action in mid-1999 to begin
removing thimerosal preservative from the vaccine supply.
While the risk of harm from this source was only
theoretical, the decision was made as a precautionary
measure. The elimination of thimerosal preservative from
vaccines was judged a feasible means of reducing an
infant’s total exposure to mercury in a world where
other environmental sources of exposure may be more
difficult or impossible to eliminate.
As a result of this action, all manufacturers of
routinely recommended licensed pediatric vaccines are now
producing for the U.S. market only vaccines that are
thimerosal-free or contain trace amounts of thimerosal.
The vaccines are supplied in single-dose vials which
eliminates the need for a preservative.
Dental
Information 
