[Congressional Record Volume 149, Number 76 (Wednesday, May 21, 2003)]
[Extensions of Remarks]
[Pages E1011-E1030]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
MERCURY IN MEDICINE REPORT
______
HON. DAN BURTON
of indiana
in the house of representatives
Tuesday, May 20, 2003
Mr. BURTON of Indiana. Mr. Speaker, I submit the following report
prepared by the staff of the Subcommittee on Human Rights and Wellness,
Committee on Government Reform. This report is the result of a three-
year investigation initiated in the Committee on Government Reform.
[[Page E1012]]
Mercury in Medicine--Taking Unnecessary Risks
I. Executive Summary
Vaccines are the only medicines that American citizens are
mandated to receive as a condition for school and day care
attendance, and in some instances, employment. Additionally,
families who receive federal assistance are also required to
show proof that their children have been fully immunized.
While the mandate for which vaccines must be administered is
a state mandate, it is the Federal Government, through the
Centers for Disease Control and Prevention (CDC) and its
Advisory Committee for Immunization Practices that make the
Universal Immunization Recommendations to which the majority
of states defer when determining mandates. Since the early to
mid-1990s, Congress has been concerned about the danger posed
by mercury in medical applications, and in 1997, directed the
Food and Drug Administration (FDA) to evaluate the human
exposure to mercury through foods and drugs.
In 1999, following up on the FDA evaluation and pursuant to
its authority, the House Committee on Government Reform
initiated an investigation into the dangers of exposure to
mercury through vaccination. The investigation later expanded
to examine the potential danger posed through exposure to
mercury in dental amalgams. This full committee investigation
complemented and built upon the investigations initiated by
two of its subcommittees. In January 2003, the investigation
continued in the newly formed Subcommittee on Human Rights
and Wellness.
A primary concern that arose early in the investigation of
vaccine safety was the exposure of infants and young children
to mercury, a known toxin, through mandatory childhood
immunizations. This concern had been raised as a possible
underlying factor in the dramatic rise in rates of late-onset
or ``acquired'' autism. The symptoms of autism are markedly
similar to those of mercury poisoning.
Significant concern has been raised about the continued use
of mercury in medical applications decades after the
recognition that mercury can be harmful, especially to our
most vulnerable population--our children. This report will
address one form of mercury in medical applications,
Thimerosal, as a preservative in vaccines.
In July 2000, it was estimated that 8,000 children a day
were being exposed to mercury in excess of Federal guidelines
through their mandatory vaccines.
One leading researcher made the following statement to the
Committee in July 2000:
``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.''
The Food and Drug Administration's (FDA) mission is to
``promote and protect the public health by helping safe and
effective products reach the market in a timely way, and
monitoring products for continued safety after they are in
use.'' However, the FDA uses a subjective barometer in
determining when a product that has known risks can remain on
the market. According to the agency, ``at the heart of all
FDA's product evaluation decisions is a judgment about
whether a new product's benefits to users will outweigh its
risks. No regulated product is totally risk-free, so these
judgments are important. FDA will allow a product to present
more of a risk when its potential benefit is great--
especially for products used to treat serious, life-
threatening conditions.''
This argument--that the known risks of infectious diseases
outweigh a potential risk of neurological damage from
exposure to thimerosal in vaccines, is one that has
continuously been presented to the Committee by government
officials. FDA officials have stressed that any possible risk
from thimerosal was theoretical: that no proof of harm
existed. Upon a thorough review of the scientific literature
and internal documents from government and industry, the
Committee did in fact find evidence that thimerosal posed a
risk. The possible risk for harm from either low dose chronic
or one time high level (bolus dose) exposure to thimerosal is
not ``theoretical,'' but very real and documented in the
medical literature.
Congress has long been concerned about the human exposure
to mercury through medical applications. As a result of these
concerns, in 1997, Congress instructed the FDA to evaluate
the human exposure to mercury through drugs and foods.
Through this Congressionally mandated evaluation, the FDA
realized that the amount of ethylmercury infants were exposed
to in the first six months of life through their mandatory
vaccinations exceeded the Environmental Protection Agency's
(EPA) limit for a closely associated compound methylmercury.
The FDA and other Federal agencies determined that in the
absence of a specific standard for ethylmercury, the limits
for ingested methylmercury should be used for injected
ethylmercury. The Institute of Medicine, in 2000, evaluated
the EPA's methylmercury standard and determined that based
upon scientific data that it, rather than the FDA's, was the
scientifically validated safe exposure standard.
Rather than acting aggressively to remove thimerosal from
children's vaccines, the FDA and other agencies within the
Department of Health and Human Services (HHS) adopted an
incremental approach that allowed children to continue to be
exposed to ethylmercury from vaccines for more than two
additional years. In fact, in 2001, the Centers for Disease
Control and Prevention (CDC) refused even to express a
preference for thimerosal-free vaccines, despite the fact
that thimerosal had been removed from almost every childhood
vaccine produced for use in the United States.
On three occasions in the last 15 years, changes have been
made to vaccine policies to reduce the risk of serious
adverse effects. First, a transition from oral polio vaccine
to injected polio was accomplished in the United States to
reduce the transmission of vaccine-induced polio. Second, an
acellular pertussis vaccine was developed and a transition
from DTP to DTaP was accomplished to reduce the risk of
pertussis--induced seizures in children. And third, when the
Rotashield vaccine for rotavirus was linked to a serious
bowel condition (intersucception), it was removed from the
U.S. market. Ethylmercury has been largely removed from every
major childhood vaccine manufactured for use in the United
States, except the influenza vaccine, which continues to
contain trace amounts.
This success, however, does not change the fact that
millions of American children were exposed to levels of
mercury through vaccines that exceeded comparable federal
guidelines. Many parents, and a growing number of scientists,
believe that this mercury exposure may have contributed to
the explosive growth in autism spectrum disorders, and
neurological and behavioral disorders that this country has
experienced. The scientific evidence in this area is
considered by some to still be inconclusive, in large part
due to the lack of serious, effective inquiry by our health
agencies. The federal government has an obligation to
vigorously pursue the necessary research to determine the
extent of the impact of these heightened exposures to
ethylmercury on our population.
A second concern that arose during the investigation was
the continued use of mercury in dental amalgams. Mercury has
been used as a component in dental fillings since the Civil
War era. The American Dental Association and its member
dentists have taken a position that the mercury in fillings,
which are considered toxic until placed in the tooth, and is
considered toxic when removed from the mouth, is completely
safe while in the human mouth. This position seems counter
even to the ADA-funded research that shows the daily release
of small amounts of mercury vapors in the human mouth where
dental amalgams are present, as well as minute chipping and
swallowing of the mercury fillings over time.
Babies and young children are exposed to this additional
mercury. As developing fetuses, babies are exposed to mercury
through the placenta. If pregnant women have mercury
amalgams, they are unknowingly excreting low levels of
mercury on a daily basis to their fetuses. Additionally,
children who receive dental services through Medicaid are
also potentially exposed to mercury. When these children need
dental fillings, because of the low cost, only mercury
amalgams are available for use. This concern remains under
investigation by the Subcommittee on Human Rights and
Wellness.
II. Findings and Recommendations
A. Findings
Through this investigation of pediatric vaccine safety, the
following findings are made:
1. Mercury is hazardous to humans. Its use in medicinal
products is undesirable, unnecessary and should be minimized
or eliminated entirely.
2. For decades, ethylmercury was used extensively in
medical products ranging from vaccines to topical ointments
as preservative and an anti-bacteriological agent.
3. Manufacturers of vaccines and thimerosal, (an
ethylmercury compound used in vaccines), have never conducted
adequate testing on the safety of thimerosal. The FDA has
never required manufacturers to conduct adequate safety
testing on thimerosal and ethylmercury compounds.
4. Studies and papers documenting the hyperallergenicity
and toxicity of thimerosal (ethylmercury) have existed for
decades.
5. Autism in the United States has grown at epidemic
proportions during the last decade. By some estimates the
number of autistic children in the United States is growing
between 10 and 17 percent per year. The medical community has
been unable to determine the underlying cause(s) of this
explosive growth.
6. At the same time that the incidence of autism was
growing, the number of childhood vaccines containing
thimerosal was growing, increasing the amount of ethylmercury
to which infants were exposed threefold.
7. A growing number of scientists and researchers believe
that a relationship between the increase in
neurodevelopmental disorders of autism, attention deficit
hyperactive disorder, and speech or language delay, and the
increased use of thimerosal in
[[Page E1013]]
vaccines is plausible and deserves more scrutiny. In 2001,
the Institute of Medicine determined that such a relationship
is biologically plausible, but that not enough evidence
exists to support or reject this hypothesis.
8. The FDA acted too slowly to remove ethylmercury from
over-the-counter products like topical ointments and skin
creams. Although an advisory committee determined that
ethylmercury was unsafe in these products in 1980, a rule
requiring its removal was not finalized until 1998.
9. The FDA and the CDC failed in their duty to be vigilant
as new vaccines containing thimerosal were approved and added
to the immunization schedule. When the Hepatitis B and
Haemophilus Influenzae Type b vaccines were added to the
recommended schedule of childhood immunizations, the
cumulative amount of ethylmercury to which children were
exposed nearly tripled.
10. The amount of ethylmercury to which children were
exposed through vaccines prior to the 1999 announcement
exceeded two safety thresholds established by the Federal
government for a closely related substance--methylmercury.
While the Federal Government has established no safety
threshold for ethylmercury, experts agree that the
methylmercury guidelines are a good substitute. Federal
health officials have conceded that the amount of thimerosal
in vaccines exceeded the EPA threshold of 0.1 micrograms per
kilogram of bodyweight. In fact, the amount of mercury in one
dose of DTaP or Hepatitis B vaccines (25 micrograms each)
exceeded this threshold many times over. Federal health
officials have not conceded that this amount of thimerosal in
vaccines exceeded the FDA's more relaxed threshold of 0.4
micrograms per kilogram of body weight. In most cases,
however, it clearly did.
11. The actions taken by the HHS to remove thimerosal from
vaccines in 1999 were not sufficiently aggressive. As a
result, thimerosal remained in some vaccines for an
additional two years.
12. The CDC's failure to state a preference for thimerosal-
free vaccines in 2000 and again in 2001 was an abdication of
their responsibility. As a result, many children received
vaccines containing thimerosal when thimerosal-free
alternatives were available.
13. The Influenza vaccine appears to be the sole remaining
vaccine given to children in the United States on a regular
basis that contains thimerosal. Two formulations recommended
for children six months of age or older continue to contain
trace amounts of thimerosal. Thimerosal should be removed
from these vaccines. No amount of mercury is appropriate in
any childhood vaccine.
14. The CDC in general and the National Immunization
Program in particular are conflicted in their duties to
monitor the safety of vaccines, while also charged with the
responsibility of purchasing vaccines for resale as well as
promoting increased immunization rates.
15. There is inadequate research regarding ethylmercury
neurotoxicity and nephrotoxicity.
16. There is inadequate research regarding the relationship
between autism and the use of mercury-containing vaccines.
17. To date, studies conducted or funded by the CDC that
purportedly dispute any correlation between autism and
vaccine injury have been of poor design, under-powered, and
fatally flawed. The CDC's rush to support and promote such
research is reflective of a philosophical conflict in looking
fairly at emerging theories and clinical data related to
adverse reactions from vaccinations.
B. Recommendations
1. Access by independent researchers to the Vaccine Safety
Datalink database is needed for independent replication and
validation of CDC studies regarding exposure of infants to
mercury-containing vaccines and autism. The current process
to allow access remains inadequate.
2. A more integrated approach to mercury research is
needed. There are different routes that mercury takes into
the body, and there are different rates of absorption.
Mercury bioaccumulates; the Agency for Toxic Substances and
Disease Registry (ATSDR) clearly states: ``This substance may
harm you.'' Studies should be conducted that pool the results
of independent research that has been done thus far, and a
comprehensive approach should be developed to rid humans,
animals, and the environment of this dangerous toxin.
3. Greater collaboration and cooperation between federal
agencies responsible for safeguarding public health in regard
to heavy metals is needed.
4. The President should announce a White House conference
on autism to assemble the best scientific minds from across
the country and mobilize a national effort to uncover the
causes of the autism epidemic.
5. Congress needs to pass legislation to include in the
National Vaccine Injury Compensation Program (NVICP)
provisions to allow families who believe that their
children's autism is vaccine-induced the opportunity to be
included in the program. Two provisions are key: First,
extending the statute of limitations as recommended by the
Advisory Commission on Childhood Vaccines from 3 to 6
years. Second, establishing a one to two-year window for
families, whose children were injured after 1988 but who
do not fit within the statute of limitations, to have the
opportunity to file under the NVICP.
6. Congress should enact legislation that prohibits federal
funds from being used to provide products or pharmaceuticals
that contain mercury, methylmercury, or ethylmercury unless
no reasonable alternative is available.
7. Congress should direct the National Institutes of Health
to give priority to research projects studying causal
relationships between exposure to mercury, methylmercury, and
ethylmercury to autism spectrum disorders, attention deficit
disorders, Gulf War Syndrome, and Alzheimer's Disease.
III. Thimerosal Has Been Used In Vaccines And Other Medical Products
For Decades
A. A brief description of mercury
Mercury is a silver-colored metal, which unlike any other
metal, is a liquid at room temperature. It flows so easily
and rapidly that it is sometimes called quicksilver. The
chemical symbol for Mercury is Hg.
Mercury has many properties that have made it popular for a
number of commercial uses. For example, mercury expands and
contracts evenly when heated or cooled. It also remains
liquid over a wide range of temperatures and does not stick
to glass. These properties have prompted its use in
thermometers. Mercury conducts electricity and is used in
some electric switches and relays to make them operate
silently and efficiently. Industrial chemical manufacturers
use mercury in electrolysis cells to charge substances with
electricity. Mercury vapor, used in fluorescent lamps, gives
off light when electricity passes through it. Before its
health effects were well understood, mercury compounds were
widely used in such common products as house paints and
paper.
Various alloys (mixtures of metals) containing mercury have
many uses. Mercury alloys are called amalgams. These would
include silver amalgam, a mixture of silver and mercury that
dentists use to fill cavities in teeth.
Mercury comes in many different forms--organic, inorganic,
elemental, and metallic. As a result of its many practical
uses, mercury became widespread in the environment. However,
it is now widely recognized that overexposure to all forms of
mercury can harm the central nervous system (brain) and the
renal system (kidneys). This has led to regulatory actions to
reduce the exposure of humans to mercury on many fronts.
According to the Agency for Toxic Substances and Disease
Registry (ATSDR): ``The nervous system is very sensitive to
all forms of mercury.''
B. Thimerosal, which contains ethylmercury, has been used in medicines
since the 1930's
In addition to its many commercial applications, mercury
has been used in a number of medical applications. One such
product that came into frequent use during the twentieth
century was thimerosal. Thimerosal is an organic compound
made up of equal parts of thiosalicylic acid and
ethylmercury. It is 49.6 percent ethylmercury by weight.
Thimerosal was developed by Dr. Morris Kharasch (1895-1957;
Ukraine/USA), a chemist and Eli Lilly fellow first at the
University of Maryland (1922-1927) and then at the University
of Chicago. He filed for a patent on June 27, 1929, for what
he described as an alkyl mercuric sulfur compound
(thimerosal), which he felt had potential as an antiseptic
and antibacterial product. Dr. Kharasch was considered a
pioneer in his field, contributing to the development of
plastics and the creation of synthetic rubber. He also went
on to found the Journal of Organic Chemistry.
In October 1929, Eli Lilly and Company registered
thimerosal under the trade name Merthiolate. Merthiolate was
used to kill bacteria and prevent contamination in antiseptic
ointments, creams, jellies, and sprays used by consumers and
in hospitals. Thimerosal was also used in nasal sprays, eye
drops, contact lens solutions, immunoglobulins, and most
importantly here--vaccines.
Thimerosal was patented the same year that Alexander
Fleming discovered penicillin. But because it took more than
a decade for penicillin to be fully developed, and large-
scale production to begin, thimerosal was widely used in the
interim. To the medical profession, who were without
antibiotics during the 1930's and 1940's, thimerosal
(marketed as Merthiolate) and other antiseptic products were
gladly received.
Dr. H. Vasken Aposhian, Professor of Molecular and Cellular
Biology and Pharmacology, University of Arizona discussed
thimerosal's history during Congressional testimony:
``In the early thirties, in fact the 1940's and up until
the mid-1950's, mercurials were used in medicine . . . The
medical community . . . 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.''
Thimerosal became the most widely used preservative in
vaccines and other medical products. Its use in antiseptic
products to prevent infections was common. By the time that
the FDA conducted its review of mercury in 1999, more than 50
licensed vaccines contained thimerosal.
While thimerosal became widely used, there were repeated
references in the scientific literature to the lack of
substantial understanding of its safety. In numerous
[[Page E1014]]
publications, researchers suggested that caution be taken in
human exposure. For example, a paper published in 1934 noted,
``little is known about the mercuric compounds when
inoculated into humans. It is therefore preferable to use the
minimum amount of this preservative.''
Eli Lilly ceased its production of vaccines in 1974.
Shortly after the FDA advisory committee determined that
thimerosal in over-the-counter products was no longer
``generally recognized as safe,'' Eli Lilly and other
companies chose to cease production of products such as
merthiolate and mercurichrome. By the mid-1980's, Eli Lilly
was completely out of the business of manufacturing or
selling thimerosal-containing products. However, thimerosal
continued to be used in vaccines. In the 1990's, thimerosal
was manufactured by numerous companies, including Sigma-
Aldrich, Inc.; EM Industries, Inc. (now EMD Chemicals Inc.,
the North American extension of Merck KGaA); Dow Chemical
Company; Spectrum Laboratory Products, Inc. (formerly
Spectrum Quality Products, Inc.); and GDL International, Inc.
C. Mercury is a known neurotoxin, but methylmercury has been more
carefully studied than ethylmercury
After more than a century of research, it has become widely
accepted in the scientific and medical communities that
mercury is a neurotoxin. While debate continues over what
levels of exposure to mercury are safe, it is unquestioned
today that overexposure to mercury in any form can cause
neurological and renal damage. There is also a growing
consensus around the theory that some individuals are more
susceptible to harm from mercury than others, confounding
efforts to adopt a population-level threshold for safe levels
of mercury in the environment. A research paper published in
2002 summarized the scientific consensus very succinctly:
``Mercury and its compounds are cumulative toxins and in
small quantities are hazardous to human health.''
Because of its many commercial applications and its
widespread presence in the environment, methylmercury
received the lion's share of the attention in the scientific
community during the twentieth century. A concise history of
the early development of scientific knowledge about
methylmercury is found in Dr. Thomas Clarkson's, ``The Three
Modern Faces of Mercury'':
``The first methylmercury compounds were synthesized in a
chemical laboratory in London in the 1860s. Two of the
laboratory technicians died of methylmercury poisoning. This
so shocked the chemical community that methylmercury
compounds were given a wide berth for the rest of the century
. . . early in the twentieth century the potent anti-fungal
properties . . . were discovered, leading to applications to
seed grains, especially for cereal crops . . . Despite the
widespread use, few cases of poisoning were reported for the
first half of the twentieth century. However, in the late
1950s and 1960s serious outbreaks of alkyl mercury poisoning
(methylmercury) erupted in several developing countries . . .
Also in the late 1950s, evidence emerged of environmental
damage from treated grain. It was observed in Sweden that
predatory birds were developing neurological disorders . . .
analysis . . . indicated a sharp rise in mercury levels.''
Public health concerns about methylmercury in the edible
tissue of fish suddenly erupted in 1969 when fish from Lake
St. Clair bordering Michigan were found to have high levels.
This and other findings . . . have maintained public health
concerns over this form of mercury.''
As a result of these emerging concerns, public health
officials worldwide began researching methylmercury. Today,
the scientific literature is replete with evidence on toxic
effects of methylmercury. In 2000, the National Academy of
Sciences published Toxicological Effects of Methylmercury,
which concluded:
Methylmercury is highly toxic.
The data indicate that the adverse effects of methylmercury
exposure can be expressed in multiple organ systems
throughout the lifespan.
The research in humans on the neurodevelopmental effects of
methylmercury is extensive.
Damage to renal tubules and nephron has been observed
following human exposure to inorganic and organic forms of
mercury. Symptoms of renal damage have been seen only at
mercury exposures that also caused neurological effects.
The cardiovascular system appears to be a target for
methylmercury toxicity in the same dose range as
neurodevelopmental effects--at very low mercury exposures.
Studies in humans on the carcinogenic effects of
methylmercury are inconclusive.
Methylmercury may increase human susceptibility to
infectious disease and autoimmune disorders by damaging the
immune system.
Methylmercury may adversely affect the reproductive system.
The medical literature is replete with references to the
dangers to methylmercury:
``The major toxic effects of methylmercury are on the
central nervous system. Its toxic action on the developing
brain differs in both mechanism and outcome from its action
on the mature organ . . . the action of methylmercury on
adults is characterized by a latent period between exposure
and onset of symptoms. The period can be several weeks or
even months, depending on the dose and exposure period . . .
paresthesia, numbness or a `pins and needles' sensation is
the first symptom to appear at the lowest dose. This may
progress to cerebella ataxia, dysarrthia, constriction of the
visual fields, and loss of hearing. . . . Cardiovascular
disease . . . accelerated progression of carotid
arteriosclerosis.''
The research is explicit that fetal brains are more
sensitive than the adult brains to the adverse effects of
methylmercury, which include:
Severe brain damage
Delayed achievement of developmental milestones
Neurological abnormalities such as brisk tendon reflexes
Widespread damage to all areas of the fetal brain, as
opposed to focal lesions seen in adult tissue
Microcephaly
Purkinje [neuron] cells failed to migrate to the cerebellum
Inhibition of both cell division and migration, affecting
the most basic process in brain development
Additionally, elevation in both systolic and diastolic
blood pressure in seven year olds correlated with prenatal
exposure to methylmercury . . . indicative of later
cardiovascular problems.
Despite the fact that ethylmercury has been widely used in
common medical treatments, ranging from vaccines to nasal
sprays to ointments, comparatively little research has been
done on its health effects. The few studies that have been
done tend to indicate that ethylmercury is just as toxic as
methylmercury.
The FDA never required the pharmaceutical industry to
conduct extensive safety studies on thimerosal or
ethylmercury. It appears that our Federal regulatory
framework (the FDA and its predecessor organizations) failed
to require manufacturers to prove thimerosal was safe. They
failed to require industry to conduct adequate testing to
determine how thimerosal is metabolized. The FDA failed to
require that industry conduct studies to determine the
maximum safe exposure level of thimerosal. These basic issues
should have been proven prior to the introduction of
thimerosal into the marketplace, but more than 70 years after
its introduction, these issues have still not been adequately
addressed. The introduction of thimerosal appears to have
been based on a single uncontrolled and poorly reported human
study in the 1920s, possibly in combination with animal and
laboratory studies. However, this sole human study was not a
true safety study and produced a faulty foundation on which
to build a robust vaccine program in which young children
would be forced to be repeatedly injected with multiple doses
of ethylmercury.
During the pre-antibiotic 1920's, meningitis was a killer.
Out of sheer desperation, the treating physician at a
hospital dealing with dozens of patients facing a sure death
from meningitis, tested thimerosal on about two-dozen
patients. He injected the thimerosal intravenously, without
apparent side effects. However, the treatment was not
successful and all of the patients died. The leading industry
scientists of that era involved in thimerosal research
published a paper that made a brief reference to this study:
``Merthiolate was injected intravenously into 22 persons . .
. these large doses did not produce any anaphylactoid or
shock symptoms.'' In the paper, the authors acknowledge that
Dr. K.C. Smithburn, the clinician who treated the meningitis
patients, was not convinced of its efficacy: ``beneficial
effects of the drug were not definitely proven.'' Drs. Powell
and Jamieson also noted in 1930 that a ``wide range of
toxicity and injury tests should be done.'' There is no
evidence that Drs. Powell and Jamieson took their own advice
and conducted studies to address these concerns.
As a result, in 1999, 70 years after the product was first
licensed, neither the FDA nor the industry had followed
through on determining a safe exposure level to thimerosal or
ethylmercury. Thus, when facing a policy decision on
thimerosal and vaccines, the FDA had to work from an
``assumption'' that the toxicity of ingested methylmercury
was the same as injected ethylmercury.
One study that compared the toxicology of ethyl and
methylmercury was published in 1985 in the Archives of
Toxicology, written by researchers from the Toxicology Unit
of the Medical Research Council of England. The researchers
exposed rats to ethyl and methylmercury to ``compare total
and inorganic mercury concentrations in selected tissues,
including the brain, after the daily administration of methyl
or ethylmercury and to relate these findings to damage in the
brain and kidneys.'' This study found that both ethyl and
methylmercury caused damage to the brains and the kidneys. It
also found that male and female rats were affected
differently:
``It has been well documented that one of the first toxic
effects of methylmercury in rats is depressed weight gain or
even weight loss . . . based on this criteria, ethylmercury
proved to be more toxic than methylmercury . . . in both
sexes . . . the concentration of total mercury (the sum of
organic and inorganic mercury) and organic mercury was
consistently higher in the blood of ethylmercury-treated rats
. . . both alkymercurials damaged the dorsal root ganglia and
9.6 mg Hg/kg/day ethylmercury caused more damage than 8.0 mg
Hg/kg/day methylmercury. Ethylmercury was more renotoxic than
methylmercury . . . tubular dilation was frequently present .
. . in kidneys . . . both damage and mercury deposits
[[Page E1015]]
were more widely spread in ethylmercury-treated rats.''
While there is frequent reference to the paucity of science
in understanding the harm that ethylmercury can do, there is
more understanding in the scientific community than
government officials have shared with the Committee. The
following dialogue between Congressman Dave Weldon (R-FL) and
Dr. David Baskin during the Committee's December 10, 2002
hearing sheds a great deal of light onto the true nature of
ethyl versus methylmercury.
Dr. Weldon: ``I have a couple of questions for Dr. Baskin
about ethylmercury versus methylmercury. I have had some
people say that data on methylmercury is fairly good, but we
don't have good data on ethylmercury. I take it from your
testimony there is actually quite a bit of data on
ethylmercury and it's as toxic as methylmercury.''
Dr. Baskin: ``There is more data, more and more data on
ethylmercury. The cells that I showed you dying in cell
culture are dying from ethylmercury. Those are human frontal
brain cells. You know, there has been a debate about . . .
ethyl versus methyl. But from a chemical point of view, most
chemical compounds that are ethyl penetrate into cells better
than methyl. Cells have a membrane on them, and the membrane
is made of lipids, fats. And ethyl as a chemical compound
pierces fat and penetrates fat much better than methyl. And
so, you know, when I began to work with some of the Ph.D.s in
my laboratory and discuss this everyone said, `oh gosh, you
know, we've got to adjust for ethyl because it's going to be
worse; the levels are going to be much higher in the cells.'
So . . . I think at best they're equal, but it's probably
highly likely that they are worse. And some of the results
that we are seeing in cell culture would support that.''
Dr. Baskin explained that according to scientific research
in humans and animals, brain tissue absorbs five times more
mercury than other tissues in the body.
Dr. Weldon: ``Now, you said several times in your testimony
that uptake in the brain is probably much higher than in
other tissues. What do you base that statement on?''
Dr. Baskin: ``Well, the literature on methylmercury is much
better than ethyl on this issue. And if you look at the
studies, the brain is 2 percent of the body weight but took
10 percent of the exposure. So that's a five-fold
preferential uptake.''
The testimony of Dr. Baskin builds upon earlier testimony
that the Committee received from recognized experts in
chemistry, toxicology and pharmacology. It includes the
following statement from Dr. H. Vasken Aposhian, Professor of
Molecular and Cellular Biology, and Pharmacology at the
University of Arizona, who provided the Committee the
following information about the evidence on mercury toxicity
at the July 18, 2000 hearing:
``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 . . .
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 . . . thimerosal,
which again will be taken up by the brain and quickly
converted to mercuric mercury--all three forms are
neurotoxic.
``By neurotoxic, we mean it will damage nerves and it will
damage brain tissues.
``Let me just say as a final statement that there is no
need to have thimerosal in a vaccine.''
In making a presentation to the Institute of Medicine's
Immunization Safety Review Committee, in July 2001, the
former Director of the Environmental Toxicology Program at
the National Institutes of Health, Dr. George Lucier,
proffered the following conclusions:
Ethylmercury is a neurotoxin.
Infants may be more susceptible than adults.
Ethylmercury should be considered equipotent to
methylmercury as a developmental neurotoxin. This conclusion
is clearly public health protective.
Ethylmercury exposure from vaccines (added to dietary
exposures to methylmercury) probably caused neurotoxic
responses (likely subtle) in some children.
While the debate over whether ethyl or methylmercury is
more toxic will probably not be resolved in the near future,
a consensus appears to be emerging that exposure to these
different types of mercury cannot be considered in isolation.
Rather, witnesses before the Committee stressed that in
determining safe levels of mercury exposure, the cumulative
level of exposure to all types of mercury must be considered.
Dr. Jeffrey Bradstreet made the following observation at the
July 19, 2002 hearing:
``More concerning to me in the Institute's treatment of
mercury problems, was the almost complete absence of regard
for compounding effect of thimerosal on preexisting mercury
levels. The NHANES Study from the CDC had already established
that perhaps one in ten children is born to mothers with
elevated mercury burden.''
D. Because of its toxicity, mercury has become heavily regulated.
As the dangers of mercury have become better understood,
the United States and other governments around the world have
taken actions to reduce the release of mercury into the
environment. In 1972, the federal government halted the use
of mercury compounds for many industrial uses, such the paint
used on the hulls of ships and compounds used to prevent the
growth of fungi in lumber, because the mercury had leached
into the environment and found its way into the human food
chain.
In 1972, while certain agencies within the federal
government recognized that mercury was a cumulative poison
that damaged brain cells, the FDA's vaccine division seems to
have ignored the issue until 1999.
1. The EPA is Regulating the Release of Mercury Into the Environment
The Environmental Protection Agency (EPA) under the Clean
Air Act regulates airborne emissions of mercury. In December
2000, the EPA announced that it would issue new regulations
on the emissions of mercury from coal and oil-fired power
plants. That action was taken because, ``mercury has been
identified as the toxic of greatest concern among all the air
toxics emitted from power plants.''
More recently, President Bush announced on February 14,
2002, that mercury emissions from power plants would be
reduced 69% under his Clear Skies Initiative. Under this
plan, mercury emissions would be reduced from the current
level of 48 tons nationally to 15 tons by 2018. The EPA also
regulates mercury emissions from municipal waste combustors,
medical waste incinerators, and hazardous waste incinerators.
The EPA works both domestically and internationally to
reduce mercury exposures in the environment. The ``Canada-
United States Strategy for the Virtual Elimination of
Persistent Toxic Substances in the Great Lakes Basin'' is an
example of these activities.
2. Different Limits to Exposure to Mercury Have Been Established by
Different Agencies
In the course of regulating mercury, different government
agencies have established different minimum risk levels for
daily exposure to mercury. Exposure to less than the minimum
risk level is believed to be safe, while exposure that
exceeds that level is believed to increase the chances of
injury. All of the levels apply specifically to ingested
methylmercury.
The EPA established the most conservative level: 0.1
micrograms of mercury per kilogram of body weight per day.
Under this standard, an 11-pound baby (roughly 5 kilograms)
could be exposed to up to 0.5 micrograms of mercury per day
and be considered safe. This exposure standard is a marked
contrast to the 25 micrograms of mercury that was contained
in several childhood vaccines until very recently.
The most lenient federal minimum risk level for mercury is
the FDA's, which sets its limit at 0.4 micrograms per
kilogram of body weight per day. (The United Nations' World
Health Organization sets a slightly higher limit of 0.47
micrograms per kilogram of bodyweight per day.) Falling in
between is the U.S. Agency for Toxic Substances and Disease
Registry (ATSDR) at 0.3 micrograms.
In 2000, the National Academy of Sciences issued a report
titled, Toxicological Effects of Methylmercury, validating
the EPA's lower limit as a ``scientifically appropriate level
that adequately protects the public.''
------------------------------------------------------------------------
Methylmercury guidelines
-------------------------------------------------------------------------
Guideline
value for
maximum
daily
consumption
(g/kg/day)
Agency (micrograms Guideline `type'
per kilogram
of
bodyweight
per day)
------------------------------------------------------------------------
EPA 0.1 Reference dose (RfD).
ATSDR 0.3 Minimal risk level.
FDA 0.4 Tolerable daily intake.
WHO 0.47 Provisional daily tolerable
intake (converted from a
weekly tolerable intake).
------------------------------------------------------------------------
The Committee repeatedly heard from government officials
that merely exceeding the guideline was not cause for
concern. One Merck official, in teaching a Grand Rounds
session to staff in November of 1999, postulated that the
minimum risk level would need to be multiplied by ten to
reach a level at which harm would be expected through
exposure. Dr. Roberta McKee of Merck wrote:
``A number of environmental and public health agencies have
set a Minimum Risk Level (MRL) for toxic substances. An MRL
for ingestion is conceptually equivalent to the Reference
Dose of the US Environmental Protection Agency, the
Acceptable Daily Intake of the US FDA, and the Tolerable
Daily Intake of the WHO. Any exposure to the substance below
the MRL is assured to be safe, while exposure to ten times
the MRL is assumed to place one at risk of overdose. Exposure
at or near the MRL is assumed to be safe but should trigger
deliberate and careful review.''
Based on Dr. McKee's explanation, many babies were exposed
to levels of mercury that ``placed one at risk of overdose,''
and were exposed to amounts well over ten times the EPA's
scientifically validated reference dose. For example, at a
recent Committee hearing, Chairman Dan Burton (R-IN)
discussed his own family's experience with vaccine injuries:
``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 have been
exposed to in one day is 1.5 micrograms, so that is 41 times
the amount at which harm can be caused.''
According to the analysis of Dr. McKee, based on the
methylmercury ingestion guidelines, the Chairman's grandson
would have
[[Page E1016]]
exceeded the ``ten times the MRL'' and therefore was placed
``at risk of overdose.'' In fact, with a 62.5 microgram
exposure alone, the EPA, ATSDR, and FDA levels would have
been exceeded by 10 times. Because the FDA chose not to
recall thimerosal-containing vaccines in 1999, in addition to
all of those already injured, 8,000 children a day continued
to be placed ``at risk for overdose'' for at least an
additional two years.
It should also be noted that none of the Federal guidelines
on mercury exposure have been included specific provisions
for safe exposure limits for infants and children. It is
widely accepted that infants and young children would be five
times more sensitive to the toxic effect of mercury or other
neurotoxins than adults. ``Exposures early in life are
reasonably of greater health concern . . . because of greater
brain organ susceptibility.''
The FDA has conceded in recent years that many children
received doses of ethylmercury through their vaccinations
that exceeded the EPA's minimal risk level for methylmercury.
However, it is also clear that many infants received doses of
ethylmercury that exceeded the FDA's higher threshold.
3. Warnings Have Been Issued About Mercury in Seafood
The FDA's actions regarding the risk of medical exposures
to mercury have differed greatly from their actions regarding
food exposures to mercury. The agency has a long history of
issuing warnings to the public to monitor their fish
consumption due to concerns about mercury exposure. During
the 1990's, the FDA repeatedly issued warnings advising
pregnant women and young children to avoid certain fish, or
to limit their consumption of these fish because of their
mercury content. In September of 1994, the FDA issued an
advisory entitled, ``Mercury in Fish: Cause for Concern?'' in
which they stated:
``Swordfish and Shark taste great--especially grilled or
broiled. But reports which state that these and other large
predatory fish may contain methylmercury levels in excess of
the Food and Drug Administration's 1 part per million (ppm)
limit has dampened some fish lover's appetites. . .`there is
no doubt that when humans are exposed to high levels of
methylmercury that poisoning and problems in the nervous
system can occur' . . . the types of symptoms reflect the
degree of exposure . . .
``During prenatal life, humans are susceptible to the toxic
effects of high methylmercury exposure because of the
sensitivity of the developing nervous system . . .
Methylmercury easily crosses the placenta, and the mercury
concentration rises to 30 percent higher in fetal red blood
cells than in those of the mother . . . none of the studies
of methylmercury poisoning victims have clearly shown the
level at which newborns can tolerate exposure . . . Pregnant
women and women of child bearing age, who may become
pregnant, however, are advised by FDA experts to limit their
consumption of shark and swordfish to no more than once a
month.''
Similarly, a March 2001 FDA advisory states:
``Some fish contain high levels of a form of mercury called
methylmercury that can harm an unborn child's developing
nervous system if eaten regularly. By being informed about
methylmercury and knowing the kinds of fish that are safe to
eat, you can prevent any harm to your unborn child and still
enjoy the health benefits of eating seafood.. . . While it is
true that the primary danger from methylmercury in fish is to
the developing nervous system of the unborn child, it is
prudent for nursing mothers and young children not to eat
these fish as well.''
In addition to the public advisories, the FDA, in January
of 2001, established an aggressive ``Education Plan on Methyl
Mercury.'' In January 2001, Associate FDA Commissioner
Melinda Plaiser, responding to Congressman William J. Coyne
(D-PA) regarding the National Academy of Sciences' report on
Methylmercury, wrote:
``[L]et me reiterate, the FDA's commitment to protecting
the public's health and the environment regarding mercury.''
Furthermore, in their training materials for employees, the
FDA reflects a slightly different emphasis on mercury's
toxicity than what they presented to the Committee:
``People are exposed every day to a tremendous number of
substances in our environment. These substances include major
and trace elements that may or may not be essential for
sustaining life . . . Other elements are not known to be
essential but are constantly found in living tissues . . . Of
these elements that have no known nutritional value, some
have been found to be toxic at concentrations well below
those of other nonessential elements. Lead, cadmium, and
mercury are examples of elements that are toxic when present
at relatively low levels.''
Other HHS entities have taken very strong mercury reduction
positions. For example, the National Institutes of Health's
(NIH) Division of Safety has initiated a program to make the
NIH mercury-free. According to the Division's own website:
``Elemental (metallic) mercury and its compounds are toxic
and exposure to excessive levels can permanently damage or
fatally injure the brain and kidneys. Elemental mercury can
also be absorbed through the skin and cause allergic
reactions. Ingestion of inorganic mercury compounds can cause
severe renal and gastrointestinal toxicity. Organic compounds
of mercury such as methylmercury are considered the most
toxic forms of the element. Exposures to very small amounts
of these compounds can result in devastating neurological
damage and death.
``For fetuses, infants, and children, the primary health
effects of mercury are on neurological development. Even low
levels of mercury exposure, such as result from a mother's
consumption of methylmercury in dietary sources, can
adversely affect the brain and nervous system. Impacts on
memory, attention, language and other skills have been found
in children exposed to moderate levels in the womb.
``The Campaign for a Mercury Free at the NIH seeks to
eliminate, as far as possible, the use of mercury in NIH
facilities; to encourage the use of safer alternatives in
biomedical research; to increase general awareness of mercury
hazards; and to prevent mercury pollution.''
This NIH program has initiated a ``Hatters Pledge'' program
to recruit scientists to reduce the use of mercury at the NIH
and to educate children on the dangers of mercury.
The NIH Hatters Pledge:
I will:
Improve my awareness of mercury hazards and how to reduce
them.
Replace mercury thermometers and other mercury-containing
items with non- or low-mercury alternatives if suitable
alternatives are available.
Dispose of mercury wastes following NIH procedures.
Report spills of mercury.
On the NIH campus, call the Fire Department (911) who are
the NIH hazardous material (HAZMAT) emergency responder.
Off campus, call the local fire department or facility's
hazardous material (HAZMAT) emergency responder.
Have areas that might have been contaminated by mercury
surveyed and decontaminated, if necessary.
4. Over the Course of Two Decades, the FDA Slowly Removed Ethylmercury
From Many Medicinal Products
In 1980, the FDA began a lengthy regulatory process to
remove ethylmercury products from over-the counter products
like topical ointments, diaper rash creams, and
contraceptives. Topical ointments are products used on the
skin either for the treatment or prevention of skin
infections or inflammatory processes. They are typically
divided into four categories, first-aid products to be
applied to small superficial wounds to prevent infection;
skin wound protectant to provide a protective barrier to
small wounds; antibiotic or antifungal creams to prevent
or treat overt skin infection; and anti-inflammatory
agents used to reduce inflammation and inhibit pruritis.
In 1980, the FDA asked their Over-the-Counter (OTC) Review
Panel to conduct a massive review of OTC products. The panel
opted to divide the task into categories, one of which was a
review of OTC products containing ethylmercury.
As a result of the panel's work, in 1982, the FDA issued a
proposed rule to ban thimerosal from OTC topical ointments.
In addition to raising questions about the general
effectiveness of thimerosal for preventing infections, the
FDA found that thimerosal was too toxic for OTC use. Among
the findings that they published were the following:
At the cellular level, thimerosal has been found to be more
toxic for human epithelial cells in vitro than mercuric
chloride, mercuric nitrate, and merbromim (mercurichrome).
It was found to be 35.3 times more toxic for embryonic
chick heart tissue than for staphylococcus aureus.
Delayed hypersensitivity in 50 percent of the guinea pigs
tested, indicating that thimerosal is highly allergic and
that it is reasonable to expect humans to be equally
allergic.
The FDA concluded that while it has been suggested that
hypersensitivity may be due to the thiosalicylate portion of
the molecule and not the ethylmercury, this was not
confirmed.
They noted a Swedish study which found in healthy subjects
the following levels of hypersensitivity to thimerosal: 10%
of school children; 16% of military recruits; 18% of twins,
and 26% of medical students.
In 1982, the FDA advisory panel concluded that thimerosal
was not generally recognized as safe: ``The Panel concludes
that thimerosal is not safe for OTC topical use because of
its potential for cell damage if applied to broken skin and
its allergy potential. It is not effective as a topical
antimicrobial because its bacteriostatic action can be
reversed.''
Despite this strong finding, the FDA's proposed ban on the
OTC use of thimerosal was not finalized until 1998, 18 years
later. At the time of the OTC review, the industry chose not
to challenge the findings of the Panel regarding the toxicity
of thimerosal in OTC products. It is unclear why the FDA
chose to do nothing for 18 years after a ``not generally
recognized as safe'' finding.
Although the FDA went through that 18-year regulatory
process to remove thimerosal from topical ointments,
apparently no one at the FDA was prompted to review the use
of thimerosal in vaccines. Action to remove thimerosal from
vaccines did not begin until 1999, in response to the
Congressionally mandated review. This will be discussed in
more detail later in this report.
At the time of the 1999 FDA review on thimerosal, it was
learned that over 50 vaccines
[[Page E1017]]
contained thimerosal. On July 9, 1999, the American Academy
of Pediatrics joined the U.S. Public Health Service in
issuing a joint statement recommending the removal of all
thimerosal from vaccines. On its website, the FDA provides
the following rationale for its policy on thimerosal:
``Over the past several years, because of an increasing
awareness of the theoretical potential for neurotoxicity of
even low levels of organomercurials, and because of the
increased number of thimerosal-containing vaccines that have
been added to the infant immunization schedule, concerns
about the use of thimerosal in vaccines and other products
have been raised. Indeed, because of these concerns, the Food
and Drug Administration has worked with, and continues to
work with, vaccine manufacturers to reduce or eliminate
thimerosal from vaccines.''
In 1999, the FDA was criticized by some for not taking more
forceful action to remove thimerosal from vaccinations; as a
result of the FDA decision to seek a gradual removal, many
children continued to receive injections of the DTaP, Hib,
and Hepatitis B vaccine that contained mercury well into
2001. Mercury-containing vaccines manufactured in the United
States, up to today, continue to be administered to infants
and small children in the United States and abroad.
E. Thimerosal is still used in some medical products
While the FDA has taken steps over the last 20 years to
remove ethylmercury from topical ointments and most pediatric
vaccines, a number of medical products continue to contain
this preservative.
Some nasal and ophthalmic products containing thimerosal
remain on the market.
About 75 percent of the flu vaccines, recently recommended
to be given to children as young as six months, contain at
least trace amounts of thimerosal.
Many adult vaccines contain thimerosal.
Vaccines containing thimerosal continue to be manufactured
in the United States and delivered through the World Health
Organization (WHO) to Third World Countries. The WHO has
continued to require the use of multi-dose vials and to use
preservatives, including thimerosal, to address storage and
transportation issues.
Of additional concern to the Committee, but not discussed
in detail within this report, is the continued use of
thimerosal in adult vaccines. There is a growing emphasis on
adult immunizations, including getting boosters to childhood
immunizations. Additionally, all new military recruits,
active duty, and reserve forces that are deploying overseas
are routinely given a large number of vaccines, many
containing ethylmercury. These vaccines are often given
consecutively and all in the same day.
U.S. MILITARY VACCINE SCHEDULE
--------------------------------------------------------------------------------------------------------------------------------------------------------
Vaccine No. Doses Initial entry Troops in US Deployed Region or other Thimerosal content
--------------------------------------------------------------------------------------------------------------------------------------------------------
Anthrax......................... 6 + annual........ N/A............... N/A............... 6 + annual........ 6 + annual........ 0
DtaP............................ N/A............... N/A............... N/A............... .................. .................. 0 (or 0.5 mcg/
dose)
Hib............................. N/A............... N/A............... N/A............... .................. (People without 0
spleens).
Hep A........................... 3 + boosters...... N/A............... 3 + boosters...... 3 + boosters...... 3 + boosters...... 0
Hep B........................... 3................. 3................. 3................. 3 (Korea)......... 3 (Korea), Health 0 (or 0.5 mcg/
Care Workers, dose)
STDs.
Influenza A&B................... 1 Annual.......... 1................. 1 annual.......... 1 Annual.......... 1 Annual (Health 25 mcg/dose or
workers). 24.5, mcg/dose or
1, mcg/dose or
.98 mcg/dose
Jap Enceph...................... 3 + biannual N/A............... N/A............... 3 + biannual 3 + biannual 35 mcg per 1 mL
boosters. boosters. boosters (Travel dose or 17.5 mcg/
Rural Asia). 0.5 mL dose
MMR (Live)...................... 1................. 1................. N/A............... Seldom needed..... NA (Health 0
workers).
Meningococcal MGC............... 1 every 3 years... 1................. N/A............... Within 3 years.... Travel to mid- 25 mcg/dose
Africa, Arabia.
Pneumococcal 17; PCBV-7......... N/A............... N/A............... N/A............... N/A............... N/A............... 0
Pneumococcal 123; PPV-23........ 1................. 1 (Pendleton)..... N/A............... N/A............... (No spleen, other 0 or 25 mcg/dose
chronic diseases).
Polio Inactivated IPV........... 1 booster dose.... 1................. N/A............... .................. (Travel Africa 0
Asia).
Rabies.......................... Pre:(3 doses + N/A............... N/A............... .................. (Veterinary bites) 0
booster).
Smallpox (Live)................. 1 every 10 years.. N/A............... 1................. 1................. 1................. 0
Td; TT (25 mcg)................. 1 every 10 years.. 1................. 1 every 10 years.. 1 every 10 years.. 1 every 10 years.. 8 mcg/dose or 25
mcg/dose.
Typhoid Injectable.............. 1 every 2 years... N/A............... 1 every 2 days.... Every 2 years..... Every 2 years 0
(travel).
Varicella (Live)................ 2 doses if needed. Screen, 2 doses... N/A............... N/A............... N/A............... 0
Yellow Fever (Live)............. 1 every 10 years.. (N, MC) 1......... 1 every 10 years.. 1 every 10 years.. 1 every 10 years 0
(travel Africa,
Pacific, South
Am).
Possible Total Thimerosal .................. .................. .................. 110.5 mcg per shot 135.5 mcg per shot ..................
Exposure. day. day.
--------------------------------------------------------------------------------------------------------------------------------------------------------
(EPA Safety Limit: 0.1 mcg/kg of body weight per day)
The Committee calculated the bolus dose exposure of adult
males and females below:
Adult weight with exposure rates according to EPA Safety
Limit
100 pound: 0.1 mcg/45.359 kg of body weight per day = 4.54
120 pound: 0.1 mcg/54.431 kg of body weight per day = 5.44
150 pound: 0.1 mcg/68.039 kg of body weight per day = 6.8
180 pound: 0.1 mcg/81.647 kg of body weight per day = 8.16
It is clear from this chart that with a maximum safe limit
of 8.16 micrograms in a day, individuals receiving either
110.5 micrograms or 135.5 micrograms in one day may be at
risk for injury from mercury exposure. Even in keeping with
the safety margin of 10 times the safety limit, purported by
Dr. Roberta McKee of Merck, individuals at each of these
weights would be exposed to levels of mercury that would be
expected to put them at risk for adverse reactions.
The Committee received documentation from one Air Force
pilot who suffered from serious symptoms of Gulf War
Syndrome. After failing to have his medical issues resolved
through the military or the Veterans Administration (VA)
medical system, Captain Frank Schmuck, a pilot, became so ill
that he was no longer able to fly. He sought medical
treatment outside the military medical system and was tested
for heavy metals, and was found to have toxic levels of
mercury in his system. After chelation therapy, he returned
to good health and has resumed flying. Gulf War Syndrome
victims are not routinely tested for heavy metal toxicity or
treated with chelation therapy by the military or the VA.
Given the lack of progress in finding other successes with
recovery from this condition, this is an issue that both the
Department of Defense (DOD) and the VA should be aggressively
evaluating on behalf of Gulf War veterans.
IV. There Are Growing Questions About Whether Mercury In Childhood
Vaccines Is Related To Autism Spectrum Disorders
A. Autism Is Growing at Epidemic Proportions
1. Introduction
Autism was once considered a rare disease that affected an
estimated 1 in 10,000 individuals in the United States. The
Committee held its first hearing on the dramatic rise in
autism in April of 2000. At the time, Federal agencies were
estimating that autism affected 1 in 500 children in the
United States. By 2002, the National Institutes of Health had
adjusted that rate to 1 in 250 children in the United States.
The Autism Society of America estimates that the number of
autistic children is growing by 10 to 17 percent each year.
In that first hearing, Chairman Burton reported that
according to U.S. Department of Education statistics,
requests for services for school-age children with autism
spectrum disorders had risen dramatically in every state.
Mr. Burton: ``California has reported a 273 percent
increase in children with autism since 1988 . . . Florida has
reported a 571 percent increase in autism. Maryland has
reported a 513 percent increase between 1993 and 1998 . . .
In 1999, there were 2,462 children ages 3 to 21 in Indiana
diagnosed with autism. That is one-fourth of 1 percent of all
the school children in Indiana, or 1 out of every 400 . . .
This increase is not just better counting. If we want to find
a cure, we must first look to the cause.''
In July 2000, Dr. Stephanie Cave shared her observations
about the rapid growth of autism and the pressures it is
placing on families and medical professionals:
``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.
``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.''
2. Studies Are Documenting the Incredible Growth of Autism
In the 1990's, the CDC conducted two prevalence studies
that confirmed dramatic spikes in autism cases. One was
conducted in Brick Township, New Jersey, the other in
Atlanta, Georgia.
In late 1997, after noticing an apparently larger than
expected number of children with autism in their community, a
citizen's group in Brick Township, New Jersey, contacted the
New Jersey Department of Health and Senior Services (DHSS).
Because of the complexity of the disorder and the concerns
that environmental factors might play a role, the New Jersey
DHSS, U.S. Senator Robert Torricelli, and U.S. Representative
Christopher Smith contacted the CDC and the ATSDR for
assistance. In response, the CDC
[[Page E1018]]
conducted an extensive prevalence investigation.
The rate of autism among children in Brick Township was 4
per 1,000 (1 in 250) children aged 3 through 10 years. The
prevalence of the more broadly defined autism spectrum
disorder was 6.7 per 1,000 (1 in 150) children. It is
important to note that even though the families of Brick
Township requested that the CDC include an evaluation of a
possible link between autism and their children's
immunization, the CDC chose not to do so. Their evaluation of
the cause of the cluster of autism in Brick Township was
inconclusive.
The CDC's Atlanta study confirmed the dramatic results of
the Brick Township study. The CDC found that 1,987 of the
289,456 children aged 3 to 10 years in metropolitan Atlanta
in 1996 were autistic (1 in 146). These numbers were 10 times
higher than studies conducted in the 1980s and early 1990s.
Last November, a study on autism in California determined
that the number of autistic individuals in that state has
nearly tripled. Equally important, the study stated that the
increase was real, and could not be explained by changes in
diagnostic criteria or better diagnoses. The study, funded by
the state legislature and conducted by the University of
California at Davis, determined that the number of autistic
people in that state grew by 273% between 1987 and 1998.
The main author of the study, Dr. Robert Byrd, said, ``It
is astounding to see a three-fold increase in autism with no
explanation . . . there's a number of things that need to be
answered. We need to rethink the causes of autism.''
The 2002 report confirmed a 210 percent increase in the
number of new children professionally diagnosed with the most
severe cases of autism entering the developmental services
system between 2001 and 2002. The system added 3,577 new
cases in 2002.
It is important to note that the figures reported in
California do not include persons with Pervasive
Developmental Disorder (PDD), PDD-Not Otherwise Specified
(PDD-NOS), Asperger's Syndrome, or any of the other milder
autism spectrum disorders. The California data reflect only
those children who have received a professional diagnosis of
level one, DSM IV autism--the most severe form of autism.
3. The Causes of the Autism Epidemic Are Not Known
The underlying causes of the explosion in autism remains a
mystery. While the medical community has made many advances
over the years in developing treatments and better diagnostic
tools, little progress has been made in understanding why
some children become autistic.
Mr. Waxman: ``Autism is a particularly frustrating disease.
We still do not understand what causes it and we still do not
have a cure. All we know for sure is that its impact on
families can be devastating. During the hearings held in this
committee, we have heard parents tell tragic stories of
children who appear to be developing normally and then all of
a sudden retreat into themselves, stop communicating, and
develop autistic behavior. Other parents have testified that
their children never start to develop language skills, and
instead early on manifest symptoms of autism. I can only
imagine how frustrating and difficult this must be for
families. And I appreciate how urgently we need to understand
what causes autism, how to treat it, and if possible, how to
prevent it.''
A summary of the developing theories on the causes of
autism, as described in ``Autism & Vaccines: A New Look At An
Old Story'' by Barbara Loe Fisher is paraphrased below:
In 1943, when child psychiatrist Leo Kanner first described
11 cases of a new mental illness in children he said was
distinguished by self-absorbed detachment from other people
and repetitive and bizarre behavior, he used the word
``autistic'' (from the Greek word auto, meaning ``self.'')
Pointing out similarities with some behaviors exhibited by
adult schizophrenics, Kanner and other psychiatrists assumed
autistic children were exhibiting early-onset adult-type
psychoses. Kanner's young patients came from well-educated
middle and upper class families in Baltimore with mothers and
fathers who were doctors, lawyers and professors. In 1954,
Kanner said, ``We have not encountered any one autistic child
who came of unintelligent parents.'' This concentration of
autistic children in educated and professionally successful
families led Kanner to develop the ``refrigerator Mom''
theory as the cause of autism, theorizing that the warm
maternal instincts of educated working mothers was absent or
diminished. Influenced by Kanner, pediatricians for decades
were persuaded to blame mothers of autistic children for
being cold and emotionally rejecting, causing the children in
turn to coldly reject contact with other people.
By 1954, Kanner began modifying his ``Blame the Mother''
position in light of evidence that brothers and sisters of
autistic children were often well-adjusted, high functioning
children. These findings suggested that the development of
autism was also a result of genetic or ``constitutional
inadequacies'' as well as bad parenting. In 1971, Kanner
admitted that Mothers were not to blame. However,
psychoanalyst Bruno Bettleheim continued purporting the
``rejecting parent'' theme. Bettleheim, a holocaust death-
camp survivor, insisted that the autistic child was behaving
in abnormal ways in retaliation against a rejecting mother
who had traumatized the child by failing to provide enough
love or attention.
However, a California psychologist and father of an
autistic child, Bernard Rimland, Ph.D., in 1964 disproved Dr.
Bettleheim's theories through the publication of his landmark
book Infantile Autism: The Syndrome and Its Implications for
a Neural Theory of Behavior. In this book, Dr. Rimland
methodically dismantled the psychoanalytic theory of autism
and argued for a biological, specifically a neurological,
basis for autistic behavior. Dr. Rimland documented the
similarities between brain injured children and autistic
children, liberating parents from the destructive guilt
associated with having an autistic child and pointing autism
research in the direction of investigating the biological
mechanisms underlying the brain and immune dysfunction
symptoms and their possible causes.
In 1965, Dr. Rimland established the Autism Society of
America (ASA). In 1967 he established the Autism Research
Institute (ARI) and began distributing a questionnaire to
parents of autistic children. Some 36 years later, his
databank includes information on more than 30,000 cases of
autism from around the world. In analyzing the data for age
of onset of autism, he discovered that before the early
1980's, most of the parents reported their children first
showed signs of abnormal behavior from birth or in the first
year of life. But after the mid-1980's, there was a reversal
of this pattern. The numbers of parents reporting that their
children developed normally in the first year and a half of
life and then suddenly became autistic doubled. Today,
Rimland says that the onset-at-18-months children outnumber
the onset-at-birth children by 2 to 1.
Today, no one can pinpoint the exact cause or causes of
autism. Nor is there any conclusive explanation for the rapid
growth in cases of late-onset autism. Most experts believe
that some combination of genetic and environmental factors
must be at work. A leading and prominent theory is that the
growing amount of mercury in childhood vaccines may have
triggered an autistic response in children who are
genetically predisposed to being vulnerable to mercury
damage.
B. The alarming growth in autism coincided with an increase in the
number of childhood vaccines containing thimerosal on the recommended
schedule
Through most of the twentieth century, individuals were
required to receive very few vaccines. However, with the
licensing of the Hepatitis B (Hep B) vaccine and the
Haemophilus Influenzae Type b (Hib) vaccine starting in the
mid-to-late 1980's, and their subsequent recommendation for
universal use in 1991, the amount of mercury to which infants
were exposed rose dramatically. It was during this period of
increased exposure to thimerosal and its ethylmercury
component that the growing wave of late-onset autism became
apparent. This confluence of events led many to suspect a
correlation between the two and call for more research into
the relationship between ethylmercury in vaccines and autism
spectrum disorders.
A number of vaccines never contained thimerosal. These
classes of vaccines are generally live-virus vaccines. The
ethylmercury in thimerosal would kill the living virus,
making it unsuitable for such vaccines. These shots include
the Measles-Mumps-Rubella (MMR) vaccine, the oral polio
vaccines (which are no longer recommended for use in the
United States), and the chicken pox (varicella zoster)
vaccines.
Prior to the approval of the recombinant Hepatitis B
vaccine in 1986, the only vaccine containing thimerosal
routinely given to infants was the DTP vaccine. DTP contained
25 micrograms of ethylmercury and was given 3 times in the
first six months of life (75 micrograms of ethylmercury) and
a total of four times in two years (100 micrograms of
ethylmercury).
The polysaccaride Haemophulus Influenzae B (Hib) vaccine
was first licensed in 1985. It had 25 micrograms of
ethylmercury and was given 3 times in the first six months of
life (75 micrograms of ethylmercury) and a total of four
times in the first two years of life.
The approval of the Hep B vaccine in 1986 added another
thimerosal-containing shot to the recommended schedule. This
vaccine contained 12.5 micrograms of ethylmercury and was
given within hours of birth and a total of 3 times in the
first six months of life (37.5 micrograms of ethylmercury).
After 1986, some children went from getting 25 micrograms
in one day or 75 micrograms in the first six months of life
to getting 62.5 micrograms of ethylmercury in a day or 187.5
micrograms in the first six months of life. This would be in
addition to any fetal exposure to mercury from the mother. In
1991, the CDC recommended that both Hib and Hep B be added to
the universal recommendations for childhood immunization.
As was noted previously, the effects of ethylmercury have
not been studied as carefully as methylmercury, and the
Federal Government has not established safety thresholds for
ethylmercury exposure. Because of the obvious similarities
between the two, however, when the FDA reviewed the amount of
injected ethylmercury in vaccines in 1999, they compared it
to the Federal limits for (ingested) methylmercury exposure.
They were compelled to admit at that point that the
cumulative amount of ethylmercury in vaccines exceeded the
EPA's threshold for exposure to methylmercury. This led the
[[Page E1019]]
FDA to recommend the removal of thimerosal from most
pediatric vaccines in 1999, more than a decade after the
Hepatitis B vaccine was added to the schedule.
In point of fact, the potential problem was worse than the
FDA suggested. Not only did the cumulative amount of
ethylmercury on the routine schedule exceed the EPA's limit,
the amount of ethylmercury in each individual shot of DTP (or
DTaP) and Hepatitis B exceeded the limit. Young children were
getting three boosters of each shot. The EPA's threshold is
0.1 micrograms of methylmercury for each kilogram of body
weight. This does not mean that injury would definitely occur
above this level because a significant safety margin is built
in. However, the chances of injury increase as the exposure
rises above this level. For an 11-pound baby (five
kilograms), the threshold would be roughly 0.5 micrograms.
For a 22-pound baby (ten kilograms), the threshold would be 1
microgram. The DTP (and DTaP) vaccine contained 25 micrograms
of thimerosal per dose, as does the Hepatitis B vaccine. The
Hib vaccine contained 12.5 micrograms per dose. In addition,
it is clear that for many, many children, the amount of
thimerosal they received in vaccines in the 1990's also
exceeded the FDA's higher threshold of 0.4 micrograms per
kilogram of body weight.
Of particular concern to many parents are those instances
in which children received several vaccines in one visit to
their pediatrician. This practice has become commonplace with
the new vaccine schedules recommending 26 doses of vaccines
before school attendance.
Chairman Burton spoke about one such incident at a recent
hearing: ``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.
When testifying before the Committee, Mrs. Lynn Redwood
made the following observation regarding her son's bolus
exposure to mercury through vaccinations: ``According to the
EPA criteria, his allowable dose was only 0.5 micrograms
based on his weight. He had received 125 times his allowable
exposure on that day. The large injected bolus exposures
continued at two months, four 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.''
Concern that autism may be linked to vaccines is not a new
debate. Twelve years ago, the Institute of Medicine was asked
to evaluate the science on a possible connection. The
Institute of Medicine published Adverse Effects of Pertussis
and Rubella Vaccines and confirmed that pertussis and rubella
vaccines can cause brain and immune system damage. At the
time, an increasing number of parents reported that their
previously normal children were regressing into autism after
DTP or MMR vaccination. However, the IOM physician committee
charged with analyzing the medical literature for evidence of
cause and effect, rejected the reported link between
pertussis vaccine and autism, because `no data were
identified [in the medical literature] that address the
question of a relation between vaccination with DTP or its
pertussis component and autism.'
Dr. Stephanie Cave, who provided testimony to the
Committee, is a doctor in Baton Rouge, Louisiana whose
medical practice is focused on treating children with the
symptoms of autism. She concurs with other experts from whom
the Committee received testimony that there appears to be a
correlation between increased use of vaccines containing
thimerosal and a rise in autism:
``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
DTP 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
ethylmercury 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.
``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.''
v. valid concerns about mercury in vaccines were ignored by federal
policymakers and vaccine manufacturers for decades
As early as 1931, scientists were noting adverse reactions
to thimerosal. In fact, Dr. Kharasch filed a new patent
application because he reformulated the product to
``stabilize merthiolate due to its tendency to acquire
`certain burning qualities'.''
In 1932, in a paper published by Lilly researchers who
found Merthiolate to be a skin-disinfecting agent, it was
noted that another researcher has seen adverse reactions.
``Reimann has reported that some individuals display a
sensitiveness to thio [thimerosal] compounds, which is
characterized by reddening of the treated area and the
appearance of small papules and vesicles.''
In 1935, in a letter from the Director of Biological
Services, of the Pittman-Moore Company to Dr. Jamieson of Eli
Lilly, ``we have obtained marked local reaction in about 50
percent of the dogs injected with serum containing dilutions
of Merthiolate varying from 1 in 40,000 to 1 in 5,000 . . .
no connection between the lot of serum and the reaction. In
other words, Merthiolate is unsatisfactory as a preservative
for serum intended for use on dogs . . . I might say that we
have tested Merthiolate on humans and find that it gives a
more marked local reaction than does phenol and
tricresol.''
In 1942, an Army doctor in Baltimore, Maryland published a
journal paper in which he raised concerns about thimerosal:
``Some investigators claim that if a patient's skin is
sensitive to one of the mercurials he may be sensitive to any
compound containing mercury. We have investigated 5 patients
with dermatitis due to Merthiolate and found that four were
sensitive to Merthiolate and not to any other organic or
inorganic mercury compounds with which they were tested . . .
Sulzberger found that in performing routine patch tests with
10 percent ammoniated mercury ointment and 10 percent
salicylic acid ointment he obtained relatively few positive
reactions; but if the two ointments were combined so that the
concentration was five percent of each, then 50 percent of
all patients tested gave positive reactions.'' Dr. Elliss
further explained in his paper, ``Dr. J. H. Mitchell in a
lecture before the American Academy of Dermatology in New
York in December 1941, stated that he had observed a number
of cases of severe dermatitis following the treatment of
dermatophytosis with preparations of Merthiolate.''
In 1943, Dr. Elliss published a case report in the Archives
of Opthalmology, which states:
``The positive results of patch tests demonstrated that the
two patients were sensitive to tincture of merthiolate were
also sensitive to 1:5000 merthiolate ophthalmic ointment and
that merthiolate is capable of causing an inflammation of the
mucous membrane in patients who are sensitive to the drug. In
view of these facts it is recommended: 1. That Merthiolate
ophthalmic ointment should not be used in or about the eye
unless it has been previously demonstrated by patch tests
that the patient is not sensitive to the ointment. 2. That
the package should be labeled to warn the consumer that such
tests should be made previous to the use of merthiolate
ophthalmic ointment in or about the eye. Since a patient may
become sensitized to Merthiolate while using the ophthalmic
ointment, it may be advisable to withdraw this product from
the market before a case of permanent ocular damage occurs,
in spite of the fact that no cases of ocular injury due to
merthiolate have been reported.''
Taken from an October 1978, letter from William R. Gibson
to Dr. Alan Baskett, of the Commonwealth Laboratories in
Victoria Australia regarding a concern that thimerosal in the
Australian pertussis vaccine was linked to intersucception in
mice:
``I discussed the possible effect of ethylmercury with
Bordetella pertussis to supplement B-adrenergic blockade.
Again, it was not believed that this blockade should
predispose toward intessusception, although it was recognized
that increased motility resulted and that this could be
causative. As with other chemicals of its generation, data
relating to its safety and pharmacological effects in animal
models are sparse.''
In August of 1998, an FDA internal ``Point Paper'' was
prepared for the Maternal Immunization Working Group. This
document, prepared almost a full year before the Public
Health Service--American Academy of Pediatrics joint
statement made the following recommendation:
``For investigational vaccines indicated for maternal
immunization, the use of single dose vials should be required
to avoid the need of preservative in multi-dose vials . . .
Of concern here is the potential neurotoxic effect of mercury
especially when considering cumulative doses of this
component in early infancy . . .''
On September 8, 1998, the Safety Working Party of the
European Agency for the Evaluation of Medicinal Products
issued its working paper, ``Assessment of the Toxicity of
Thimerosal in Relation to Its Use in Medicinal Products.''
The Working Party concluded:
[[Page E1020]]
``There is ample evidence from the literature that
thiomersal (thimerosal) may cause sensitization and
subsequent allergic reactions . . . the use of thimerosal is
vaccines given to infants in accordance with various national
vaccine programs may in certain cases result in approximately
two times higher intake of ethylmercury during the first year
of life than what can be considered reasonably safe. Given
the great uncertainty of the estimations of safe levels in
young children, it is suggested to restrict the use of
thimerosal in vaccines.''
In June of 2000, the CDC convened a closed meeting to
discuss research evidence that showed a connection between
thimerosal in vaccines and neurological injury. Dr. Thomas
Verstraeten, a CDC employee who has since left the agency to
work in Belgium for a vaccine manufacturer, utilized the
Vaccine Safety Datalink to evaluate any possible connection
between thimerosal-preserved vaccines and neurological or
renal impairment. He found, ``a statistically significant
positive correlation between the cumulative exposure at 2
months and unspecified developmental delay; the cumulative
exposure at 3 months and tics; the cumulative exposure at 6
months and attention deficit disorder . . . 1, 3 and 6 months
and language and speech delay . . . 1, 3, and 6 months of age
and neurodevelopmental delays in general.''
He concludes:
``This analysis suggests that in our study population, the
risks of tics, ADD, language and speech delays, and
developmental delays in general may be increased by exposures
to mercury from thimerosal-containing vaccines during the
first six months of life.''
This issue will be discussed in more detail in another
section of this report.
The Committee and the public have been frustrated by the
Department of Health and Human Services reluctance to accept
that all forms of mercury are toxic and that children have
likely been harmed from the FDA's negligence in assuring the
safety of thimerosal and in not monitoring the increased
exposure to mercury through vaccines.
During the July of 2000 hearing on mercury, Congresswoman
Helen Chenoweth-Hage (R-ID) eloquently expressed the views of
many.
Mrs. Chenoweth-Hage:
``. . . 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.
``You know, I still go back to the fact--I still want to
talk about the duck test. Mr. Egan, [FDA] 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.''
In 2003, thimerosal remains in some vaccines.
A. Many parents of autistic children believe that adverse reactions to
vaccines are responsible for their children's condition
Based on their personal experiences, many parents believe
that the autistic condition of their children is related to
an adverse reaction to a childhood vaccine, or a series of
vaccinations. This is particularly true of parents of
children who have developed ``late onset autism,'' in which
symptoms do not begin to emerge until the child is between
one and two years old. This time period coincides with a
number of vaccinations on the childhood schedule. While this
belief is not universal, many parents hold it passionately.
Dr. Jeffrey Bradstreet, when testifying before the
Committee in 2001, made the following statement:
``At a recent autism conference in Chicago, and prior to
either my own presentation or that of Dr. Wakefield, I asked
the audience of 500 parents if they felt their child
regressed following a vaccine. In that obviously non-
scientific survey, approximately 90 percent the parents
raised their hands to affirm vaccines were what they
suspected had caused their child's symptoms. When I asked for
how many had reported the event under the VAERS system, fewer
than 15 said they had. Then I asked if their pediatrician had
offered to report this, they just laughed. I have now
conducted this simple survey with over 5000 parents at
conferences around the world with similar findings. Yes,
media attention creates bias. But despite the informal nature
of this survey, it does tell us something about this debate
we are currently engaged in: (1) parents of children with
autism suspect vaccines damaged their child, (2) parents are
not reporting this using VAERS forms, (3) pediatricians are
not reporting to VAERS either, (4) and despite efforts by
policymakers at CDC, FDA, AAP, IOM and elsewhere to reassure
parents of the safety of vaccines, they remain unconvinced.''
The Committee has heard moving testimony from parents in
support of this belief, as well as from parent-advocates.
Shelley Reynolds is a mother of two from Baton Rouge,
Louisiana. When she testified before the Committee in April
of 2000, her autistic son, Liam, was four years old. Her
testimony left no doubt as to her views:
``Liam was a normally developing baby until June 27, 1997,
when he received his MMR and Hib vaccines. He did everything
he was supposed to do. He cooed, rolled over, crept, crawled,
pulled up and walked on time. He said `Mama,' he said
`Daddy,' he said `Love you.' He learned how to sing `Itsy
Bitsy Spider.' He played finger games with us. He loved to
interact, and he especially loved to show off for his
grandparents.''
* * * * *
``But when he was 17 months old, shortly after he had
received the shots, he started exhibiting some different
behaviors. He was constantly taking off his shoes; he
screamed if we dressed or undressed him; he would stare for
hours in front of the television and would not move if you
blocked the view. He could not tolerate playing in the
sandbox anymore. He did not want to sing any of his favorite
songs; he would cover his ears and scream `No.'''
* * * * *
``In Liam's case, we have no doubt that he developed his
autism as a direct result of an adverse vaccine reaction.''
* * * * *
``Many in the medical community continue to dismiss this as
mere happenstance because autism often coincides with the
time of vaccination, and state that there is no scientific
evidence to back this up. My question to you is: How long
does it take for a coincidence to surface time and time and
time again, case after case after case, before it can become
a viable hypothesis, especially when the solution to solving
the problem seems so apparent?''
At the same hearing, the Committee heard testimony from
Jeana Smith of Denham Springs, Louisiana. At the time, she
was the mother of five-year-old twins, one of whom was
autistic. Her testimony made equally clear her conviction
that her son's autism was related to a series of vaccinations
given on the same day:
``Jacob met every developmental milestone that first year,
right along with Jesse. They were two little peas in a pod
and went everywhere together. At only 16 months of age, Jacob
and Jesse received their first MMR vaccine. On this same day,
they also received their fourth DTP, their fourth Hib, and
their third hepatitis B. The following 24 hours, both twins
slept most of the time, with over 100-degree temperatures, in
spite of receiving the recommended Tylenol dosage every 6
hours. Immediately following that, Jacob began exhibiting
strange behaviors. He was no longer excited or responsive
when Daddy would come home from work. He began to become
preoccupied with certain toys. He would spend long periods of
time studying the way their wheels would spin or whether or
not they were lined up just right. Any attempt to interrupt
or distract him was met with great resistance and an eventual
fit.
[[Page E1021]]
During this time, Jesse continued to progress, starting to
talk and interact with all the children around him.''
* * * * *
``At times, Jacob was so withdrawn that we could absolutely
not reach him.''
* * * * *
``For us, there is no denying that in Jacob's case of
autism, the answer does not lie in genetics, but in a
catalyst. The thousands of hours of research that we have
spent searching and retracing his regression continue to
point to the fact that the road of Jacob's autism began when
his immune system was damaged by the hepatitis B vaccine he
received when he was ill. The final blow was the adverse
reaction to the host of vaccines he received 16 months later.
We are certain that for Jacob, the catalyst was his
vaccine.''
Testifying two years later, on April 18, 2002, Autism
Society of America President Lee Grossman testified about the
strongly held views of many of the Society's members:
``A substantial number of families within our autism
community believe some forms of autism may be caused by some
use of vaccines. While we do not know this to be specifically
proved at this time, we should not ignore the body of
evidence that calls into question the source of many children
with autism. If causation is found, those injured must be
provided recourse and compensation.''
* * * * *
``I think the stories that I have heard that many of our
members tell, that many of these people in the audience will
tell you, is that they believe that there is evidence that
there is a direct linkage, a direct causation of vaccines
causing their child's autism. I think it is imperative for
us, the advocates in the room, for ASA, and for Congress, for
the lay public, to stand together to get this question
answered, answered immediately.''
B. Many parents of autistic children have filed petitions for
compensation or lawsuits against vaccine manufacturers
Not surprisingly, suspicions that there may be a causal
relationship between some vaccines and autism have spawned a
significant amount of litigation.
As of October 2002, more than 875 families had filed
petitions for compensation under the Federal Vaccine Injury
Compensation Program (VICP), alleging that a vaccine or a
series of vaccines caused their child's autism. It has been
estimated that as many as 3,000 to 5,000 such petitions may
be filed in the near future.
Congress established the VICP in 1987 to provide
compensation to families of individuals who suffer vaccine
injuries. The Federal government maintains a trust fund out
of which awards are paid and which is funded by an excise tax
on vaccines. Petitions for compensation are adjudicated
before a team of special masters, with the Justice Department
representing the Federal government.
With the knowledge that the growing number of petitions
seeking compensation for autism spectrum disorders poses a
difficult challenge for the VICP, the Chief Special Master
laid out a special two-part procedure for resolving these
claims. First, a general causation inquiry known as the
``Omnibus Autism Proceeding'' will be conducted to determine
generally if vaccines can cause autism disorders, and if so,
under what circumstances. The two-year schedule for
completing this omnibus proceeding includes a discovery
period for establishing an evidentiary record, testimony of
expert witnesses, an evidentiary hearing, and a ruling on
general causation issues by July of 2004. In the second part
of the two-part procedure, the Special Master's determination
in the omnibus proceeding will be applied to individual
cases.
Thus far, there are two primary contentions underlying all
of the autism cases filed in the VICP. The first is that the
MMR vaccine has caused autism in some children. The second
alleges that the mercury contained in several other vaccines
caused neurological damage, resulting in autism spectrum
disorders. These contentions are summarized in the Master
Autism Petition For Vaccine Compensation filed by the
families:
``As a direct result of one or more vaccinations covered
under the National Vaccine Injury Compensation Program, the
vaccine in question has developed a neurodevelopmental
disorder, consisting of an `Autism Spectrum Disorder' or a
similar disorder. This disorder was caused by a measles-
mumps-rubella (MMR) vaccination; by the `thimerosal'
ingredient in certain Diptheria-Tetanus-Pertussis (DTP),
Diphtheria-Tetanus-acellular Pertussis (DTaP), Hepatitis B,
and Hemophilus Influenza Type B (HIB) vaccinations; or by
some combination of the two [vaccine administrations].''
In addition to petitions filed under the VICP, many parents
have filed lawsuits against vaccine manufacturers and
manufacturers of thimerosal. The first such lawsuit was filed
in Texas in May of 2001 on behalf of five-year-old Joseph
Alexander Counter (Counter v. American Home Products).
According to his parents and attorneys, he was diagnosed with
autism and then was found to have high levels of mercury
exposure. Later that year, a group of law firms calling
themselves the ``Mercury Vaccine Alliance'' filed class
action lawsuits in nine different states.
While dozens of lawsuits have been filed, they generally
fall into three different categories:
1. Actions claiming that thimerosal is an adulterant or a
contaminant in a vaccine;
2. Actions seeking compensation for loss of consortium
(love and companionship) on behalf of parents of autistic
children; and
3. Class actions seeking compensation for autistic children
and medical monitoring for broad populations of children who
were exposed to mercury in vaccines.
Under the National Childhood Vaccine Injury Act, which
created the Vaccine Injury Compensation Program, victims of
vaccine injuries are not allowed to file lawsuits against
vaccine manufacturers unless they have first sought
compensation through the VICP. However, one exception allows
lawsuits for vaccine injuries allegedly caused by an
``adulterant'' or a ``contaminant'' intentionally added to
the vaccine. In twin decisions in May of 2002, a Federal
judge ruled that thimerosal could not be considered an
adulterant or a contaminant, and claims filed on that basis
were dismissed. However, in those same decisions, the court
ruled that parents of vaccine-injured children are entitled
to seek damages in court for loss of consortium without going
through the VICP.
As these cases work their way through the courts,
procedural rulings in different jurisdictions will have a
great influence on whether potentially thousands of families
seek compensation through the courts or through the VICP.
VI. A Growing Number of Scientists and Doctors Believe That a
Relationship Between Thimerosal in Vaccines and Autism Spectrum
Disorders is Plausible
A. Introduction
A growing number of respected scientists and researchers
are convinced that there is a relationship between the use of
thimerosal in childhood vaccines and the growing incidence of
autism. A number of these scientists have testified before
the Committee. At the same time, senior officials from
Federal health care agencies and other public health experts
continue to insist that there is no evidence of such a
relationship.
Two things appear to be clear in this debate. First,
concerns about the use of thimerosal in vaccines existed in
public health agencies for more than two decades before
action was taken to remove them from vaccines. The lethargic
response to these legitimate concerns will be discussed in
the following section of this report. Second, much more
research needs to be done before any conclusive
determinations can be made about vaccines and autism spectrum
disorders. Developing more and better research data will be
critically important to resolving the legal disputes over
compensation for children with autism, and restoring the
confidence of the American public in vaccines.
This section will review the current state of the
scientific debate over vaccines and autism.
B. Institute of Medicine reports call for more research
In 2001, the Institute of Medicine (IOM) released two
reports after reviewing the evidence they received related to
possible connections between vaccines and autism. The IOM was
created by the National Academy of Sciences in 1970 to
conduct independent analyses of public policy matters related
to health care. The first report dealt with the MMR vaccine.
The second dealt with vaccines containing thimerosal. The
common thread linking both reports was the conclusion that
much more research needed to be done before firm conclusions
could be drawn.
In April of 2001, the IOM issued its report on the MMR
vaccine, entitled, ``Immunization Safety Review--Measles-
Mumps-Rubella Vaccine and Autism.'' After reviewing the
available scientific studies, the IOM determined that: ``The
evidence favors rejection of a causal relationship at the
population level between MMR vaccine and autism spectrum
disorders.''
The IOM stated that the epidemiological evidence available
at the time showed no association at a population level
between the MMR vaccine and autism. However, the authors
cautioned that if the vaccine triggered autistic disorders
among a small number of children who were predisposed to an
adverse reaction, the population studies that had been done
to-date would be too imprecise to detect them:
``It is important to recognize the inherent methodological
limitations of such studies in establishing causality.
Studies may not have sufficient precision to detect very rare
occurrences on a population level. A poor understanding of
the risk factors and failure to use a standard case
definition may also hamper the ability of epidemiological
studies to detect rare adverse events.''
The IOM recommended further research to determine if
exposure to the MMR vaccine is a risk factor for autism
disorders in a small number of children. They also called for
targeted studies to follow up on a groundbreaking series of
case studies by Dr. Andrew Wakefield of Great Britain, who
determined that 12 British children who suffered from autism
spectrum disorders and chronic bowel inflammation also had
vaccine-strain measles virus in their tissues. Although the
parents of eight of the twelve children traced the onset of
autistic symptoms to the time period when the MMR vaccination
was given, the IOM stated that the study was of limited
utility because of its small sample size.''
Six months later, the IOM issued its second report,
entitled, ``Immunization Safety Review--Thimerosal-Containing
Vaccines
[[Page E1022]]
and Neurodevelopmental Disorders.'' They found insufficient
evidence to accept or reject a connection between thimerosal
in vaccines and autism. They did, however, state that such a
connection is ``biologically plausible,'' and recommended
much more research on the issue.
The report summarized:
``The committee concludes that although the hypothesis that
exposure to thimerosal-containing vaccines could be
associated with neurodevelopmental disorders is not
established and rests on indirect and incomplete information,
primarily from analogies with methylmercury and levels of
maximum mercury exposure from vaccines given in children, the
hypothesis is biologically plausible.''
* * * * *
``The committee concludes that the evidence is inadequate
to accept or reject a causal relationship between exposure to
thimerosal from vaccines and the neurodevelopmental disorders
of autism, ADHD, and speech or language delay.''
The IOM noted that it had reviewed the results of one
unpublished epidemiological study that detected a
``statistically significant but weak association'' between
exposure to thimerosal-containing vaccines and several types
of developmental disorders, including attention deficit
disorder, speech and language delay, tics, and general
neurodevelopmental delays. Phase I of the study, which was
performed with data from the CDC's Vaccine Safety Datalink,
(VSD) uncovered the aforementioned associations.
Phase II of the study, which provided enough data to
analyze only speech delays and attention deficit disorder,
did not detect an association between those disorders and
thimerosal, as had Phase I. After being briefed on both
phases of the study, the IOM's Immunization Safety Review
Committee agreed that they were inconclusive. The ``VSD
Study'' is discussed at greater length in Section VII.
The IOM also noted with some discomfort that thimerosal had
not been removed from all vaccines and medicines given to
children and pregnant women. The report specifically cited
the influenza vaccine, the diphtheria-tetanus toxoid vaccine,
and some nasal sprays. They urged that, ``full consideration
be given by appropriate professional societies and government
agencies to removing thimerosal from vaccines administered to
infants, children or pregnant women in the United States.''
It was also recommended that any remaining stocks of
childhood vaccines containing mercury be removed from
doctor's offices and replaced with mercury-free alternatives.
Finally, the report recommended that numerous types of
research be conducted to help the scientific community better
determine if there is a causal relationship between
thimerosal and autism or other disorders. The IOM called for:
Case-control studies examining the potential link between
neurodevelopmental disorders and thimerosal-containing
vaccines;
Further analysis of cohorts of children who did not receive
thimerosal-containing doses of vaccines during clinical
trials;
Epidemiological studies comparing the prevalence of
neurological disorders in children, who received vaccines
before thimerosal was removed, to children who received
vaccines after it was removed;
An increased effort to identify the primary sources and
levels of prenatal and postnatal exposure to thimerosal;
Clinical research on how children metabolize and excrete
metals;
Theoretical modeling of ethylmercury exposures, including
the incremental burden of thimerosal on background mercury
exposures from other sources;
Research in appropriate animal models on neurodevelopmental
effects of ethylmercury;
Rigorous scientific investigations of chelation as a
treatment for neurodevelopmental disorders; and
Research to identify a safe, effective and inexpensive
alternative to thimerosal for countries that decide they want
to follow the example of Europe and the United States and
terminate its use in vaccines.
C. A growing number of researchers believe that there may be a
relationship between vaccines and autism spectrum disorders
A growing number of researchers and medical professionals
believe that there may be a link between the mercury
preservative used in vaccines and autism spectrum disorders
and other neurodevelopmental disorders. Few, if any, would
make such a statement categorically until more research is
done. However, judging by testimony received by the
Committee, many researchers believe that this hypothesis is
plausible based on work they have done to-date. They believe
that this is a promising field of research that may yield
breakthroughs on the question of the underlying causes of the
growing incidence of autism and other neurodevelopmental
disorders.
On April 25, 2001, the Committee heard testimony from Dr.
Boyd E. Haley, who is the Chairman of the Chemistry
Department at the University of Kentucky. Dr. Haley has
spent many years studying the effects of mercury on the
human body. Dr. Haley summarized his views in this way:
``I cannot say, nor would I say, that vaccinations cause
autism. However, if the data holds up that I have been seeing
with the relationship, I think it is an awfully good suspect,
at least one of the co-factors that might aid in the onset of
this disease. So I would really recommend and encourage you
to put some pressure on the National Institutes of Health
(NIH) to look at the contribution of different forms of
mercury we put in our medicines and in our dentistry to see
what effect they have on the neurological health of
Americans.''
In his testimony, Dr. Haley described his laboratory
research on thimerosal:
``I was requested to do an evaluation of the potential
toxicity of vaccines containing thimerosal as a
``preservative'' versus those vaccines not containing
thimerosal. The results were very dramatic as shown in the
accompanying Table attached to this document. In our
preliminary studies, vaccines containing thimerosal as a
preservative consistently demonstrated in-vitro toxicity that
was dramatically greater than the non-thimerosal or low-
thimerosal containing vaccines.''
* * * * *
``Our results are very consistent with the reported
toxicity of thimerosal-containing vaccines versus non-
thimerosal containing vaccines as observed in cell culture
studies reported in 1986. The chemical rationale for the
neurotoxicity of thimerosal is that this compound would
release ethyl-mercury as one of its breakdown products.
Ethyl-mercury is a well-known neurotoxin. Further, combining
thimerosal with millimolar levels of aluminum cation plus
significant levels of formaldehyde, also found in these
vaccines, would make the vaccine mixture of even greater risk
as a neurotoxic mixture.''
Dr. Haley went on to state that infants are more
susceptible to damage from mercury, because the defense
mechanisms in their bodies are less well developed:
``Infants, with their immature physiology and metabolism,
would not be expected to handle mercury as efficiently as
mature adults.''
* * * * *
``Using this vaccine mixture on infants, who do not have
fully developed bilary (liver) and renal (kidney) systems,
could dramatically increase the toxic effects, especially if
they are spuriously ill. The toxic effects of exposure to
thimerosal in infants cannot be reasonably compared to those
observed in adults made toxic by exposure to similar ethyl-
mercury containing compounds. Mercury is primarily removed
through the bilary system and aluminum is removed by the
renal system. Inability to rid the body of these toxicants
would greatly increase the damage they are capable of doing
in infants.''
Dr. Haley's concerns about the inability of infants to fend
off the adverse effects of mercury were echoed by Dr. David
Baskin. Dr. Baskin is a neurosurgeon and a professor of
neurosurgery and anesthesiology at Baylor College of
Medicine. He has been involved in extensive research on the
central nervous system and serves on scientific advisory
boards of the National Institutes of Health. Testifying
before the Committee in December of 2002, Dr. Baskin said:
``We clearly know infants' brains are more sensitive. We
know the blood-brain barrier, the barrier to drugs between
the blood and the brain, is virtually gone in infants.''
Virtually all researchers who have testified before the
committee have hypothesized that some children must have a
genetic predisposition that makes them more vulnerable to
neurological damage from mercury. An exchange between
Congressman Burton and Dr. Baskin at the December 10, 2002,
hearing reflected this emerging consensus:
Mr. Burton: ``Do you personally believe from your studies
that the mercury is a contributing factor to the cases of
autism we have in this country?
Dr. Baskin: ``Yes.''
Mr. Burton: ``Do you think it's a large contributing
factor, or do you have any percentages? I mean, I know this
is a tough question and everything, but you have done a lot
of research.''
Dr. Baskin: ``I think it's hard to look at a percentage. I
think that, as NIH is focusing on, there is probably an
environment-gene interaction. In other words, a lot of
children get the injection and don't become autistic, and so
there must be something specific or different about the way a
certain subgroup of children are able to handle toxins. . . .
I don't think we yet know the answer to that.''
In his testimony the previous year, Dr. Haley of the
University of Kentucky described one possible genetic risk
factor. He stated that there is a protein in the brain called
APO-E that removes dangerous waste materials from the brain.
He added that some individuals are born with a variety of
this protein that is very efficient at removing mercury,
and some individuals are born with a variety of this
protein that is very inefficient at removing mercury:
``If you look at the chemistry of the APO-E proteins, this
can be reflected in the fact that it is a housekeeping
protein that clears the brain of waste materials. If you have
APO-E2, you can carry out two atoms of mercury for every atom
of APO-E that goes out. If you have APO-E4, you can carry out
none.
``He [Dr. Mike Godfrey of New Zealand] took this and looked
at autistic children. When he did the screen of autistic
children, there was a huge preponderance of them that had
APO-E4, indicating that there is a genetic risk factor, which
deserves further study. And it does imply that the inability
[[Page E1023]]
to detoxify the cerebral spinal fluid may be at least part of
the neurological aspect of this disease.''
Dr. Baskin described research he is conducting which
demonstrates what the effects of mercury are when it is not
removed from brain tissue:
``Let me turn to some studies that we're doing at Baylor
College of Medicine. We have the opportunity to actually grow
human frontal cortex cells in cell culture. So these are
cells from the front part of the brain that grow in culture.
We incubate these cells with thimerosal at various doses, and
we use a number of very sophisticated techniques to detect
cell death and cell damage.''
* * * * *
``Here are some pictures from our cell culture experience,
and you can see the arrows pointing to those little knobs
sticking off the cell. These are the cells committing the
suicide program and breaking themselves into tiny little
pieces with a very low dose of mercury.''
``Here is a slide where you see a lot of blue cells. This
is a blue dye that normal cells don't take up. In order for
something to turn blue, the cell has to have holes punched in
their membranes. And guess what: At an extraordinarily low
dose of thimerosal, most of the cells are blue. It means that
this stuff grabs a hold of the membrane and punches holes
into it, so that the dye can penetrate, not only into the
cytoplasm but into the very center of the cell, the nucleus,
where all the DNA exists.''
* * * * *
``Don't forget, we did this in adult brain cells. Remember
that infant brain cells are much more sensitive, so there's a
real cause for concern.''
Dr. Baskin testified that other researchers in his field
are finding similar results:
``At the recent International Meeting for Autism Research
at the Society for Neuroscience, a number of investigators
around the world are finding similar things. At Columbia
University, there's now a model in mice who were injected
with low doses of thimerosal very similar to what's given in
human vaccines. These mice develop neurological deficits that
look like autism, and when you take their brains out and you
analyze them, they have the same type of brain damage.''
D. Public health officials continue to defend the use of thimerosal in
vaccines
Public health officials continue to resist the idea that
thimerosal may have contributed to the growth in autism
spectrum disorders. In public statements as recently as
December of 2002, Federal officials have continued to defend
the use of thimerosal, despite the fact that:
They asked vaccine manufacturers to remove thimerosal from
childhood vaccines more than three years ago;
In the 1990's, they acknowledged that many children
received a cumulative amount of ethylmercury in vaccines that
exceeded the EPA's safe limits for methylmercury;
One Federally sponsored study showed an association between
thimerosal in vaccines and some developmental disorders.
On April 18, 2002, the Committee heard testimony from
Melinda Wharton, Director of the Epidemiology and
Surveillance Division of the CDC's National Immunization
Program. Her response to a question about mercury in vaccines
hinted at the skeptical attitude that prevails at the CDC and
the FDA:
``As far as the thimerosal issue is concerned, the evidence
is too incomplete and fragmentary to make any decisions about
causation. Of course, many substances are known to be
dangerous when administered in high concentrations, but the
additives that are included in vaccines are present in trace
amounts, and even when multiple vaccines are given, these are
still very small amounts of products. It is not established
even that thimerosal is associated with any harm as a vaccine
additive.
``That said, we have committed a large amount of staff time
and funding to try to further elaborate these issues and have
designed a whole series of studies that have been described
in our written testimony that we believe will help address
these issues.''
She further stated:
``There are not data to--there are no established harms
associated with this. I know this is a subject of great
concern, and a number of studies are underway, but we do not
have data that support known hazards associated with
thimerosal contained in vaccines at this point.''
Later in 2002, Dr. Karen Midthun, Director of the FDA's
Office of Vaccines Research and Review, expressed almost
identical views:
``Our review showed no evidence of harm caused by
thimerosal used as a preservative in vaccines except for
local hypersensitivity reactions.''
* * * * *
``To date, the existing data do not demonstrate a causal
relationship between vaccines and autism. Nonetheless, I want
to assure this committee, the public, and especially parents,
that the FDA continues to take these issues seriously.''
In her testimony, Dr. Midthun attempted to downplay the
extent to which the exposure to ethylmercury from vaccines in
the 1990s exceeded the EPA's threshold for methylmercury
exposure:
``During the first 6 months of life, cumulative exposure to
mercury could have exceeded the more conservative limits of
the EPA in some cases, depending on the specific vaccine
formulations used and the weight of the infant.''
There is no question that the cumulative amount of
ethylmercury on the recommended schedule of childhood
vaccinations exceeded the EPA's threshold for methylmercury.
In fact, there is little doubt that the amount of
ethylmercury in individual vaccines exceeded the threshold.
The EPA's threshold is 0.1 micrograms per kilogram of body
weight. For an eleven-pound baby, the EPA's safe threshold
would be 0.5 micrograms. Although thimerosal has been removed
from these vaccines today in the United States, in the
1990's, Aventis Pasteur's DTaP vaccine contained 25
micrograms of thimerosal. GlaxoSmithKline's Hepatitis B
vaccine contained 12.5 micrograms of thimerosal. Wyeth
Lederle's Hib vaccine contained 25 micrograms of thimerosal.
Dr. Midthun's carefully couched statement suggested that
there were many instances in which U.S. infants were exposed
to cumulative levels of ethylmercury from their vaccines that
were significantly lower than the EPA threshold for
methylmercury. In the 1990's, at least, this does not appear
to have been the case. It is clear that the DTaP, Hepatitis B
and Hib vaccines exceeded the EPA's threshold individually
for almost all infants, without even considering cumulative
amounts. In fact, as will be discussed in the next section of
this report, the amount of ethylmercury in these vaccines
also exceeded the FDA's higher threshold of 0.4 micrograms
per kilogram for most babies.
One vaccine policymaker, who was at least partially swayed
by the Faroe Islands studies and other evidence, was Dr. Neal
Halsey, Director of the Institute of Vaccine Safety at Johns
Hopkins University. Dr. Halsey was an influential member of
Federal advisory committees that oversaw the expansion of the
Federally recommended schedule of childhood vaccines in the
1990s. By all accounts, Dr. Halsey was instrumental in the
decision to seek the removal of Thimerosal from childhood
vaccines in 1999.
In contrast to Dr. Midthun's statements, Dr. Halsey told
the New York Times that he was astonished when he reviewed an
FDA analysis of how much mercury was in vaccines being given
to children:
``My first reaction was simply disbelief, which was the
reaction of almost everybody involved in vaccines. In most
vaccine containers, thimerosal is listed as a mercury
derivative, a hundredth of a percent. And what I believed,
and what everybody else believed, was that it was truly a
trace, a biologically-insignificant amount. My honest belief
is that if the labels had had the mercury content in
micrograms, this would have been uncovered years ago. But the
fact is, no one did the calculation.''
``My first concern was that it would harm the credibility
of the immunization program. But gradually it came home to me
that maybe there was some real risk to the children.''
In a statement released by Johns Hopkins University after
the publication of the profile in the New York Times, Dr.
Halsey clarified that he still does not believe that there is
a connection between thimerosal and autism:
``Neal Halsey, MD, . . . does not and has not supported the
belief that thimerosal or vaccines themselves cause autism in
children, saying scientific evidence does not suggest any
causal association between any vaccine and autism.''
However, Dr. Halsey's statement made it equally clear that
he believes that there may be an association between
exposures to low levels of mercury and other neurological
impairments. His statement referred specifically to the Faroe
Islands studies and the calculation that the cumulative
amount of thimerosal in childhood vaccines exceeded the EPA's
limits for methylmercury:
``In 1999, Dr. Halsey became concerned that the use of
thimerosal as a preservative in many vaccines led to some
children being exposed to more ethylmercury than was
recommended, based on guidelines from the Environmental
Protection Agency for exposure to methylmercury, a related
product. Recent studies have determined that children who as
fetuses were exposed to low to moderate amounts of
methylmercury through fish consumed by their mothers were at
an increased risk for having mild neurological learning
deficiencies. The findings from the studies did not show an
association between methylmercury exposure and autism.''
* * * * *
``As a precaution and in an effort to make vaccines as safe
as possible, Dr. Halsey worked with the American Academy of
Pediatrics and the Public Health Service in 1999 to urge
reductions in exposure to mercury, in all its forms, for
infants and children, and to discontinue using thimerosal as
a preservative whenever possible.''
E. Research on the effects of thimerosal has been too limited to draw
conclusions
To date, very little epidemiological or clinical research
has been done on the neurological effects of thimerosal, and
particularly its ethyl-mercury component. As the IOM noted in
its report on thimerosal, ``the data regarding toxicity of
low doses of thimerosal and ethylmercury are very limited,''
and most of the conclusions that have been drawn about
ethylmercury are based on analogies to methylmercury, which
has been more widely studied. The few studies that have been
performed on ethylmercury have been of limited value, for
several reasons.
[[Page E1024]]
Perhaps Dr. Thomas Verstraeten conducted the broadest
review of a possible relationship between thimerosal and
neurological disorders in 2000. This study reviewed several
years of medical records from the Vaccine Safety Datalink
maintained by the CDC. As noted earlier, Phase I of this
study purported to find a statistically significant
association between exposure to thimerosal and some
neurological disorders. However, this study has never been
published. Moreover, because the data used in the study comes
from the Vaccine Safety Datalink, and because the medical
records in this database are jealously guarded by the CDC,
the data used in this study has never been made public. It is
discussed at greater length in the next section of this
report.
In November of 2002, a study on thimerosal conducted at the
University of Rochester was published in The Lancet, Great
Britain's premiere medical journal. The authors studied 40
children who were given vaccines containing thimerosal, and
21 children who were given vaccines without thimerosal.
Samples of blood, stools and urine were obtained from 3 to 28
days after vaccination to determine how much mercury remained
in the blood and how much was expelled in the urine and in
stools.
The authors found low levels of mercury in the blood of
infants exposed to thimerosal, and high levels of mercury in
their stools, indicating to them that ethylmercury has a
shorter half life then methylmercury, and that most of the
mercury was excreted through the gastro-intestinal tract.
According to the authors:
``We have shown that very low concentrations of blood
mercury can be detected in infants aged 2-6 months who have
been given vaccines containing thiomersal [sic]. However, no
children had a concentration of blood mercury exceeding 29 .
. . parts per billion, which is the concentration thought to
be safe in cord blood.''
The authors went on to conclude:
``Overall, the results of this study show that amounts of
mercury in the blood of infants receiving vaccines formulated
with thiomersal [sic] are well below concentrations
potentially associated with toxic effects. Coupled with 60
years of experience with administration of thiomersal-
containing vaccines, we conclude that the thiomersal in
routine vaccines poses very little risk to full-term infants,
but that thiomersal-containing vaccines should not be
administered at birth to very low birth weight, premature
infants.''
Skeptics of a vaccine-autism connection hailed this study.
However, its value is limited by a number of criticisms that
have been raised since its publication. Some of the most
commonly cited shortcomings were discussed in testimony at
the Committee's December 10, 2002, hearing by Baylor
University's Dr. Baskin.
1. The sample size was very small:
Only 40 children who received thimerosal were studied. If a
small number of children were genetically predisposed to
injury by mercury, the chances of a sample of 40 children
detecting such a trend would be very low. In his testimony,
Dr. Baskin stated:
``The sample size, as you said, Dr. Weldon, was small.
Autism occurs in one in 150 kids. So if a child had some
different tendency in their blood to absorb more mercury or
have it remain in the blood longer or be more sensitive in
their brain, if they only checked 40 kids, they may well not
have found even one kid with a predisposition to autism.''
2. The sample was not random:
In his testimony, Dr. Baskin commented on the importance of
a random sample size:
``The sample wasn't random. They didn't take kids from
different portions of the population in different areas. If
there's some metabolic difference based on race or sex or
where you live or other things, they wouldn't have found
it.''
3. Blood samples were drawn too late to detect peak levels
of mercury:
In an effort to determine how long it takes ethylmercury to
be expelled from an infant's body, and what the expected
half-life of injected ethylmercury is, the authors drew blood
from their subjects at varying times between three and 28
days after shots were administered. However, as Dr. Baskin
notes, peak levels of mercury in the blood are expected to
appear within 24 hours:
``We know the stool levels were high, but if you look at
when they actually measured the blood levels, they said it
was somewhere between 3 and 27 days later. The peak mercury
levels after injection occur within hours or at least within
the first 24 hours. So if they were drawing blood later than
that, and much later than that, of course the levels weren't
going to be high. But the mercury doesn't jump from the
injection to the stool; it goes through the blood. At some
point it was high because it was high in the stool.''
* * * * *
``You can't do a pharmacokinetic study if you don't have
the peak level. They clearly didn't have the peak level
because they have high stool mercury, and they have low blood
mercury--it doesn't make sense.''
4. The study did not measure the effects of mercury on
infants, only the levels of mercury:
While the University of Rochester study measured the levels
of mercury in infants' bodies at various times beyond peak
levels, it did not attempt to determine the effects of the
mercury on their bodies. This limitation was clearly brought
out in an exchange between Congressman Burton and Dr.
Christopher Portier, Director of the Environmental Toxicology
Program at the National Institute of Environmental Health
Sciences:
Mr. Burton: ``Does the study recently published in The
Lancet identify the effects of mercury on infants who are
vaccinated with thimerosal?''
Dr. Portier: ``No.''
Given the small sample size, the failure to measure mercury
at peak levels, and the study's inability to measure the
effects of the ethylmercury present in the bodies of the
subjects, it is difficult to understand how the authors can
come to the broad conclusion that, ``the thimerosal in
routine vaccines poses very little risk to full-term
infants.'' If anything, the limitations of this study point
out the need for much more research to be done. As Dr. Baskin
pointed out:
``They described this as a descriptive study, and that's
exactly what it was. It provides some interesting
information, it's a start, but the interpretation is
inaccurate.''
VII. Evidence of Ethyl Mercury's Toxicity Was Neglected By
Manufacturers and Federal Regulators for Years
A. Introduction
Evidence of ethylmercury's toxicity was available to
Federal regulators and the private sector almost from the
product's inception. For far too long, both neglected this
evidence. Despite evidence dating to the 1930s that
ethylmercury in medicines was potentially hazardous, little
was done to remove it from a number of products until the
1980's. Even then, regulatory actions to remove thimerosal
and other mercury compounds from medical products proceeded
at a glacial pace. The decision to remove thimerosal from
topical ointments was not finalized until 1998. The removal
of thimerosal from several childhood vaccines in the United
States wasn't accomplished until after the turn of the
century. Today, the vaccine for influenza given to infants
still contains trace amounts of ethylmercury.
For decades, ethylmercury was used as a preservative or
anti-bacterial agent in a range of products, including
antiseptic ointments for treating cuts, nasal sprays, eye
solutions, diaper rash treatments, contraceptive products,
and perhaps most importantly, vaccines. Several years after
an FDA advisory committee found that thimerosal wasn't safe
for use in topical ointments, new childhood vaccines
containing thimerosal were being approved and added to the
recommended schedule. It appears that nobody analyzed the
potential impact of the increased cumulative amount of
mercury to which young children were being exposed. In fact,
if Congress had not enacted legislation in 1997 requiring the
FDA to study the amounts of mercury being used in FDA-
approved products, it is questionable that the FDA would
have analyzed mercury in vaccines at all.
It is no wonder that, in its report on thimerosal, the
Institute of Medicine commented:
``The presence of mercury in some vaccines can raise doubts
about the entire system of ensuring vaccine safety, and late
recognition of the potential risk of thimerosal in vaccines
may contribute to a perception among some that careful
attention to vaccine components has been lacking.''
It is clear that the guiding principal for FDA policymakers
has been to avoid shaking the public's confidence in the
safety of vaccines. For this reason, many FDA officials have
stubbornly denied that thimerosal may cause adverse
reactions. Ironically, the FDA's unwillingness to address
this issue more forcefully, and remove thimerosal from
vaccines earlier, may have done more long-term damage to the
public's trust in vaccines than confronting the problem head-
on. Given the serious concerns about the safety of
thimerosal, the FDA should have acted years earlier to remove
this preservative from vaccines and other medicines.
B. Thimerosal manufacturers accumulated evidence of the toxicity of
thimerosal
Eli Lilly and Company of Indianapolis licensed thimerosal
in 1930. It was marketed under the brand name
``Merthiolate.'' It was used extensively both in topical
ointments to prevent infections and as a preservative in a
variety of medicines. However, it now appears that very
little research on the safety or effectiveness of thimerosal
was ever done.
Eli Lilly was not the only manufacturer of thimerosal or
other ethylmercury products. In fact, they phased out their
production of thimerosal in 1974. However, Eli Lilly
initially patented this product and had a longer history with
it than any other company. Therefore, it is appropriate to
review Lilly's track record in ensuring the safety and
reliability of this product.
A review of internal Eli Lilly documents dating back 70
years suggests that the only study of thimerosal involving
human subjects was done prior to 1930. For the next seven
decades, Lilly spokespeople would refer to that original
study as evidence of thimerosal's safety. However, it is now
clear that this uncontrolled study was woefully inadequate.
As previously discussed in this study, an intravenous
solution containing thimerosal was tried as an experimental
treatment for 22 men who were seriously ill with Meningitis.
While the treatment was found to be ineffective, the doctor
who conducted the study concluded that the solution caused no
harmful side effects. It is clear today that such a limited
number of subjects, all suffering from the same serious
illness, would
[[Page E1025]]
hardly qualify as a sufficiently sized random sample, and a
study such as this one would be of very little value by
today's standards. In fact, an internal Eli Lilly memo from
1972 candidly notes the study's shortcomings:
``Considering the type of patient involved, one might
question these observations (the appearance of no deleterious
action) as providing adequate indication of any harmful
effects of high doses of Merthiolate in humans, in
particular, more long term effects.''
In 1973, the FDA requested additional data on Merthiolate
from Eli Lilly. Lilly's Director of Regulatory Affairs, E.A.
Burrows, responded with a ringing defense of Lilly's product
on February 14, 1973:
``Due to the length of time this product has been on the
market, its efficacy and safety have been proven by over
forty years of use throughout the world. Because of this long
period of use, it would be difficult to get recognized
researchers to conduct new studies for safety or efficacy.
They believe that over forty years of wide usage has proven
efficacy and safety beyond that which could be done in
special studies.''
Despite Mr. Burrow's contention, numerous internal Lilly
documents recognized the lack of data on thimerosal and
suggested the need for more research:
An April 24, 1930, intra-office memo stated:
``. . . in view of our experience with the merthiolate
solution, we have to know pretty definitely what to expect
from merthiolate ointment and jelly before they are put on
the market . . . Can we expect to have the stronger ointment
and jelly used without complaint which attended the use of
the solution in the same strengths? . . . Our experience with
the solution ought to serve as a warning and certainly in the
face of that warning we ought not to advocate the use of the
stronger products without some pretty definite evidence that
we will not repeat our solution experience.''
A September 1934, paper from Lilly's files states:
``[L]ittle is known about the effect of mercuric compounds
when inoculated into humans. It is therefore preferable to
use the minimum amount of this preservative necessary to
maintain the sterility of the product.''
An April 1969, memo regarding the possible use of
thimerosal in contact lens solution states:
``When Merthiolate breaks down, are the degradation
products toxic or irritating? Our files yield no test
information on the irritancy of degraded merthiolate.''
* * * * *
``Would we recommend the use of merthiolate solution to
store and sterilize contact lenses? In the absence of
appropriate data, a positive recommendation could not be
made, this use does not seem unreasonable and probably would
not be hazardous.''
A December 1972, memo states:
``A review of some data being generated by the current
concern for mercury in the environment suggests it would be
advisable to obtain data on the metabolic deposition of
Merthiolate.'' . . .
An August 1973, memo entitled, ``Merthiolate Toxicity,''
acknowledged:
``The effects of long-term, intravenous use in man is not
known, no long-term toxicity tests have been performed.''
Perhaps more disturbing is that Lilly's files contained
numerous papers and reports documenting the toxicity and
hypersensitivity of Merthiolate. Although these papers and
case reports strongly suggested the need for much more
research, there apparently was little follow-up.
A July 1935, letter from the Pittman-Moore Company
indicated that Merthiolate was not appropriate for use in
dogs:
``We have obtained marked local reaction in about 50% of
the dogs injected with serum containing dilutions of
Merthiolate, varying in 1 in 40,000 to 1 in 5,000, and we
have demonstrated conclusively that there is no connection
between the lot of serum and the reaction. In other words,
Merthiolate is unsatisfactory as a preservative for serum
intended for use on dogs. Occasional dogs do not show the
local reaction, but in some instances, the reaction is
extremely severe. I might say that we have tested Merthiolate
on humans and find that it gives a more marked local reaction
than does phenol or tricresol.''
A 1947 paper published by an Army physician in Baltimore
reported that Merthiolate was causing contact dermatitis in
his patients. He concluded:
``No eruptions or reactions have been observed or reported
to Merthiolate internally, but it may be dangerous to inject
a serum containing Merthiolate into a patient sensitive to
Merthiolate.''
A 1948 paper from an Arizona doctor reported the case of a
woman who suffered repeated multiple reactions to Merthiolate
applied to her skin prior to surgery. She reportedly suffered
chills and fevers and had small vesicles and erythema in the
area of her Merthiolate application. After her recovery, the
patient indicated that the ulcer for which she was being
surgically treated appeared after repeated application of a
tincture of Merthiolate. She continued applying the
Merthiolate until her skin became too raw and painful to
continue use, and then sought medical care.
A 1950 New York Academy of Sciences article entitled,
``Mercurials as Antiseptics,'' found that Merthiolate ``is
toxic when injected parenterally and therefore cannot be used
in chemotherapy.''
A 1973 article, entitled, ``Dangers of Skin Burns from
Thimerosal,'' reported the case of a woman who received
severe burns resulting from a chemical interaction between
thimerosal and aluminum. The article suggested that
thimerosal and aluminum should not be used together. Later in
1973, Lilly's legal department recommended new labeling
language for thimerosal products: ``Do not use when aluminum
may come in contact with treated skin.'' Unfortunately,
thimerosal and aluminum were used together in the DTP and
DTaP vaccines for years.
C. The FDA was painfully slow to require the removal of mercury from
over-the-counter (OTC) products.
In 1974, the FDA undertook a comprehensive review of the
safety and effectiveness of over-the-counter medicines. As
one facet of this review, a panel of experts was assembled to
review the safety and efficacy of over-the-counter drugs
containing mercury. The Advisory Review Panel on OTC
Miscellaneous External Drug Products began this review in
1975. In 1980, the panel delivered its report to the FDA. It
reviewed 18 products containing mercury, and found them all
either unsafe or ineffective for their stated purpose of
killing bacteria to prevent infections.
In terms of effectiveness, the panel stated that, ``mercury
compounds as a class are of dubious value for anti-microbial
use.'' They stated that, ``mercury inhibits the growth of
bacteria, but does not act swiftly to kill them.'' In fact,
the panel cited a 1935 study of the effectiveness of
thimerosal in killing staphylococcus bacteria on chick heart
tissue. The study determined that thimerosal was 35 times
more toxic to the heart tissue it was meant to protect than
the bacteria it was meant to kill.
In terms of safety, the panel cited a number of studies
demonstrating the highly allergenic nature of thimerosal and
related organic mercury products. For instance, they cited a
Swedish study that showed that 10 percent of school children,
16 percent of military recruits, 18 percent of twins, and 26
percent of medical students had hypersensitivity to
thimerosal. They stated that while organic mercury compounds
like thimerosal were initially developed to decrease the
toxicity of the mercury ion, thimerosal was actually found to
be more toxic than bichloride of mercury for certain human
cells.
By way of summary, they stated the following:
``The Panel concludes that thimerosal is not safe for OTC
topical use because of its potential for cell damage if
applied to broken skin, and its allergy potential. It is not
effective as a topical antimicrobial because its
bacteriostatic action can be reversed.''
Despite the fact that the expert committee found thimerosal
and other ethyl-mercury compounds unsafe and ineffective for
over-the-counter products, the FDA would not formally require
the removal of mercury from these products for another 18
years. The submission of the committee's report in 1980 set
in motion a tortuous bureaucratic process that would not
result in the banning of mercury from over-the-counter
products until 1998. The agency published Advanced Notice of
Proposed Rules or Notice of Proposed Rules regarding these
products in 1980, 1982, 1990, 1991, 1994 and 1995.
What makes the glacial pace of these proceedings all the
more mystifying is that there appears to have been no
opposition to this action throughout the process. No
individuals sought to appear before the advisory committee in
defense of mercury-containing products, and when the FDA
sought public comment along the way on proposed rules to ban
certain mercury-based products, it received none. At the time
of the FDA's final action, there were 20 over-the-counter
products containing mercury being marketed by eight different
manufacturers. Their silence on this point is telling.
D. The FDA's actions to remove mercury from over-the-counter products
should have prompted a review of mercury in vaccines.
It is difficult to understand why it took the FDA 18 years
to remove mercury from over-the-counter products. It is
equally difficult to understand why the expert panel's 1980
findings on thimerosal's safety in topical ointments did not
prompt the FDA to further and immediately review the use of
thimerosal in vaccines. Surely there must have been concern
that if it was not safe to apply ethylmercury to the surface
of an individual's skin, it might not be safe to inject
ethylmercury deep into an infant's tissue. The Director of
the FDA's National Center expressed such a concern at a 1999
meeting for Toxicological Research, Dr. Bernard Schwetz, who
went on to serve as the Acting Director of the FDA for nearly
a year:
``One thing I haven't heard discussed, the fact that we
know that ethylmercury is a skin sensitizer when it's put on
the skin, and now we're injecting this IM (intramuscularly)
at a time when the immune system is just developing, the
functionality of the immune system is just being set at this
age. So now we're injecting a sensitizer several times.
During that period of time, what's the impact of a
sensitizer--of something that is known to be a skin
sensitizer, what is the effect on the functional development
of the immune system when you give a chemical of that kind
repeatedly IM?''
Different branches of the FDA regulate over-the-counter
products and vaccines. OTCs are regulated by the Center for
Drug Evaluation and Research (CDER). Vaccines are regulated
by the Center for Biologics
[[Page E1026]]
Evaluation and Research (CBER). This, however, is little
justification for the lack of coordination. The FDA's
determination that mercury was unsafe and should be removed
from over-the-counter medications was published in the
Federal Register no fewer than five times prior to the FDA's
belated review of mercury in vaccines.
What finally prompted the FDA to review mercury in vaccines
was not its own regulatory process, but rather an act of
Congress. In 1997, Congress passed and the President signed
into law, the Food and Drug Administration Modernization Act
(FDAMA). Among other things, this law required the FDA to
compile a list of foods and drugs that contained
intentionally-introduced mercury, study its effects on the
human body, and restrict its use if found to be harmful.
E. Federal regulators moved too slowly to remove thimerosal from
vaccines
Once the FDA did initiate its review of mercury in
vaccines, it kicked off a vigorous debate among Federal
regulators over the dangers of using thimerosal in childhood
vaccines. This debate, which at times pitted one health-care
bureaucracy against another, spanned nearly three years.
Given the fact that almost twenty years had passed since an
expert panel had determined that thimerosal was unsafe in
topical ointments, it is surprising that there was any
further debate at all.
There was tremendous reluctance on the part of some
officials to admit that a mistake had been made in allowing
ethylmercury to be used in vaccines. There was great
uncertainty in others caused by the lack of data specifically
on ethylmercury. However, the institutional resistance to
change was counter-balanced by the growing realization that
there was more ethylmercury in childhood vaccines than
previously thought, and that nobody had thought to calculate
the cumulative amounts. The essence of the debate was
captured in a 1999 e-mail from a former FDA official weighing
the pros and cons of taking action. He opined that hastening
the removal of thimerosal from vaccines would:
``. . . raise questions about FDA being `asleep at the
switch' for decades by allowing a potentially hazardous
compound to remain in many childhood vaccines, and not
forcing manufacturers to exclude it from new products. It
will also raise questions about various advisory bodies
regarding aggressive recommendations for use. (We must keep
in mind that the dose of ethylmercury was not generated by
`rocket science'. Conversion of the percentage thimerosal to
actual micrograms of mercury involves ninth grade algebra.
What took the FDA so long to do the calculations? Why didn't
CDC and the advisory bodies do these calculations when they
rapidly expanded the childhood immunization schedule?)''
It is clear that each time an important decision had to be
made, the factions that were skeptical of thimerosal's
dangers and favored a ``go-slow'' approach, were able to
water down the actions. In 1999, when the Federal government
could have ordered thimerosal removed from vaccines by a
specific date, or stated a preference for thimerosal-free
vaccines, a statement was instead issued asking for a
commitment from vaccine manufacturers to eliminate or reduce
mercury in vaccines as expeditiously as possible. As a
result, almost two years passed before the three major
thimerosal-containing vaccines--DTaP, Hib and Hepatitis B--
were being manufactured in thimerosal-free formulations. In
2001, when the CDC and its influential advisory committee
could have stated a preference for thimerosal-free vaccines,
they chose not to do so. As a result, thimerosal-containing
vaccines that remained in stock in doctors' offices continued
to be used. In point of fact, we have no proof that in 2003,
some children in the United States are not still receiving
thimerosal-preserved vaccines that have lingered in medical
offices or clinics.
The CDC's decision not to endorse thimerosal-free vaccines
in 2001 is particularly troubling. With the exception of the
influenza vaccine, all major childhood vaccines were being
manufactured without thimerosal at that time, so there was
little threat of shortages. Their failure to state a
preference was an abdication of their responsibility.
The task of analyzing the amount of mercury in vaccines and
its ramifications was assigned to Dr. Leslie Ball, a
pediatrician employed at the FDA and her husband and
colleague Dr. Robert Ball, a medical officer at FDA's CBER.
Despite the general lack of scientific research on the
toxicity of ethylmercury, their review of the available
literature led to two working conclusions:
1. The recommended guidelines for exposure to methylmercury
were a good starting point for reviewing exposure to
ethylmercury; and
2. The amount of ethylmercury in children's vaccines
exceeded the EPA's guidelines for exposure to methylmercury.
An exchange of e-mails in October of 1998 makes clear that
Dr. Leslie Ball was already leaning toward the removal of
thimerosal from vaccines. It also makes clear that there was
internal resistance to such an action. Dr. Marion Gruber of
the Office of Vaccine Research and Review forwarded an
internal FDA memo to Dr. Ball, which concluded that:
``. . . no scientific database to take regulatory actions
and to recommend to take thimerosal either out of vaccines or
to leave it in. In fact, somebody should perform the adequate
studies to come to a conclusion on the toxicity of thimerosal
or its metabolized forms.''
Dr. Ball's response on October 15, 1998, to Dr. Hasting's
conclusion was sharp:
``I disagree about the conclusion regarding no basis for
removal of thimerosal. On a strictly scientific basis, yes,
there are no data that have looked at the specific issue of
thimerosal in vaccines. However, there are factors/data that
would argue for the removal of thimerosal, including data on
methylmercury exposure in infants and the knowledge that
thimerosal is not an essential component to vaccines. In
addition, the European community is moving to ban
thimerosal.''
In a 2002 interview with Committee staff, Dr. Ball
confirmed that it was her opinion that, if there was any
question, the safest course of action should be taken, and
thimerosal should be removed.
An important part of the FDA's review was a comparison of
the amount of ethylmercury in vaccines to the recommended
safe levels for exposure to methylmercury established by the
EPA and the FDA. In 1999, a consultant to the FDA, Dr. Barry
Rumack, developed a pharmacokinetic model to analyze the
amount of mercury to which infants were being exposed. The
FDA produced to the Committee two charts developed from that
model dated June 28, 1999. Both charts demonstrate what has
now become widely acknowledged, that most children in the
1990s received doses of ethylmercury in their vaccines that
exceeded the EPA's limits for exposure to methylmercury (0.1
micrograms per kilogram) for at least the first six months of
their lives. Even more significantly, the charts also
indicate that most children received doses of ethylmercury
that exceeded the FDA's less-restrictive limits (0.4
micrograms per kilogram) for at least the first two months of
their lives.
Federal officials have never publicly acknowledged this
second fact. In public statements and Congressional
testimony, they have acknowledged only that the EPA's lower
limit was exceeded, even though simple math makes clear that
most infants also breached the FDA's higher limit of 0.4
micrograms per kilogram.
Dr. Neal Halsey, Director of the Institute of Vaccine
Safety at Johns Hopkins University, acknowledged this
important fact, however. As previously mentioned, Dr. Halsey
became convinced that thimerosal should be removed from
vaccines. On June 22, 1999, Dr. Ball presented the results of
her research to the Medical Policy Coordinating Committee of
the FDA's Center for Biologics Evaluation and Review (CBER).
Dr. Halsey attended that meeting. The next day, on June 23,
1999, Dr. Halsey wrote a letter to the members of the
American Academy of Pediatricians' Committee on Infectious
Diseases, which he chaired. He stated:
``In the past few days, I have become aware that the amount
of thimerosal in most hepatitis B, DTaP and Hib vaccines that
we administer to infants results in a total dose of mercury
that exceeds the maximum exposure recommended by the EPA, the
FDA, CDC and WHO . . .''
Dr. Halsey's admission that more than just the EPA's more
conservative guideline was exceeded is a significant
departure from the public statements of most Federal
officials. Dr. Halsey acknowledges that the guidelines of the
EPA, the CDC, the FDA and the World Health Organization were
all exceeded.
Another noteworthy fact is that the charts produced by Dr.
Rumack, and the FDA's analysis in general, failed to take
into consideration the background levels of mercury to which
children are exposed from other sources. Dr. Ball pointed out
this weakness in her June 1999 e-mail:
``These calculations do not account for other sources of Hg
[mercury] in the environment. Even infants can have
additional exposures, e.g., breast milk.''
One document written by Dr. Ball estimated that exposure to
mercury from sources other than vaccines could total roughly
80 to 100 micrograms per year. Background levels were
included in all calculations prepared by the European Medical
Evaluation Agency, which was at the time reviewing thimerosal
in vaccines in Europe. If background levels of mercury had
been incorporated into the FDA's and CDC's calculations, the
results would have been even more pronounced, possibly even
leading to more aggressive measures to remove thimerosal. It
is unfortunate that this simple, and scientifically expected
step was not taken.
The issue of what to do with thimerosal in vaccines came to
a head in the summer of 1999. In June and July, a series of
meetings were held involving the FDA, the CDC, the Public
Health Service, the American Association of Pediatricians,
and other agencies. Documents reviewed by the Committee
indicate that the Public Health Service opposed a public
effort to remove thimerosal from vaccines. One FDA document
stated that the Public Health Service was concerned that
stating a preference for thimerosal-free vaccines could
``result in unwarranted loss of confidence in immunization
programs in the US and internationally, shortages of
childhood vaccines might ensue, and other potential far-
reaching ramifications are envisioned.''
In a July 2, 1999, e-mail, Dr. Ruth Etzel of the Department
of Agriculture also noted the Public Health Service's
resistance:
``We must follow the three basic rules: (1) act quickly to
inform pediatricians that the products have more mercury than
we realized; (2) be open with consumers about why
[[Page E1027]]
we didn't catch this earlier; (3) show contrition. As you
know, the Public Health Service informed us yesterday that
they were planning to conduct business as usual, and would
probably indicate no preference for either product. While the
Public Health Service may think that their `product' is
immunizations, I think their `product' is their
recommendations. If the public loses faith in the PHS
recommendations, then the immunization battle will falter. To
keep faith, we must be open and honest now and move forward
quickly to replace these products.''
Adding to the pressure on the Federal government to act was
the fact that steps were being taken in Europe to remove
thimerosal from vaccines. On April 19, 1999, the European
Agency for Medicinal Evaluation (EMEA) met in London. The
EMEA is responsible for establishing guidelines for the use
of drugs and biologics in the European Union. The FDA's Dr.
Norman Baylor attended this meeting. Following this meeting,
on June 29, 1999, the EMEA issued a document encouraging the
removal of thimerosal from childhood vaccines:
``Vaccines: The fact that the target population for
vaccines in primary immunization schedules is a healthy one,
and in view of the demonstrated risks of thiomersal (sic) and
other mercurial containing preservatives, precautionary
measures (as outlined below) could be considered.
``For vaccination in infants and toddlers, the use of
vaccines without thimerosal [emphasis added] and other
mercurial preservatives should be encouraged.''
By early July, a compromise on a course of action was
reached in the U.S. between the competing factions. A joint
statement was released by the American Academy of Pediatrics
and the U.S. Public Health Service. The statement included
the following points:
Acknowledged that some children may have been exposed to
levels of mercury that exceed one Federal guideline on
methylmercury during the first six months of life;
Asserted that there is no evidence of any harm caused by
thimerosal in vaccines;
Called on vaccine manufacturers to make a clear commitment
to reduce as expeditiously as possible, the mercury content
of their vaccines;
Urged doctors and parents to immunize all children, even if
thimerosal-free vaccines are not available; and
Encouraged doctors and parents to postpone the Hepatitis B
vaccine (which contained thimerosal at the time, and was
generally given immediately after birth) until the child is
two to six months old, unless the mother tested positive for
Hepatitis B.
Given the information that the Federal agencies had at the
time, the plan of action laid out in the joint statement was
inadequate. They could have, but did not, acknowledge that
the amount of thimerosal in vaccines exceeded every Federal
guideline for exposure to methylmercury for the majority of
infants. They could have, but did not, require vaccine
manufacturers to remove thimerosal from vaccines by a
specific date. They could have, but did not, urge
pediatricians to choose thimerosal-free vaccines when both
thimerosal-containing and thimerosal-free vaccines were
available.
As a result of the limited steps taken in 1999, vaccines
containing thimerosal remained on the market for nearly two
years. GlaxoSmithKline's Hepatitis B vaccine did not become
thimerosal-free until March of 2000, and Aventis Pasteur's
DTaP vaccine did not become thimerosal-free until March 2001.
In addition, thimerosal-containing vaccines on the shelves in
doctor's offices around the country continued to be used in
spite of the fact that thimerosal-free versions were
available.
The fact that more forceful action to remove thimerosal
from the vaccine marketplace was not taken in 1999 is
disappointing. Just as disappointing, and even more difficult
to understand, is the fact that the CDC, on two separate
occasions, refused to publicly state a preference for
thimerosal-free vaccines.
In June of 2000, the CDC's Advisory Committee on
Immunization Practice met in Atlanta. Among other things, the
Advisory Committee was called upon to recommend whether the
CDC should issue a public statement of preference for
thimerosal-free vaccines. At the time, the industry was in
the midst of its transition to thimerosal-free childhood
vaccines, and several vaccines containing thimerosal were
still on the market. Of particular concern was the DTaP
vaccine. In June of 2000, three of the four DTaP
manufacturers (Aventis Pasteur, North American Vaccine and
Wyeth) were still producing DTaP with thimerosal. Only
SmithKline Beecham produced a thimerosal-free DTaP. In
addition, because manufacturers of the Hib and Hepatitis B
vaccines had just recently converted to formulas that were
thimerosal-free or contained trace amounts of thimerosal,
older versions of these vaccines containing thimerosal were
still in inventories and being used around the country.
A statement of preference by the CDC would have been a
clear signal to pediatricians not to use vaccines containing
thimerosal, when thimerosal-free versions were available.
This action would have substantially reduced the exposure to
ethylmercury for many infants. Despite this knowledge, the
advisory committee voted unanimously not to state a
preference.
CDC officials guided the Advisory Committee toward this
conclusion. For example, while three different options were
presented to the Advisory Committee members, a detailed
policy statement to be issued to the public had been prepared
for only one of these options--a statement of no preference.
In describing the three options, Dr. Roger Bernier of the CDC
clearly indicated the CDC's desire not to state a preference
for thimerosal-free vaccines. He said:
``We believe that such a policy would be consistent with
the evidence that we have at this time. The policy seems to
be working . . .''
* * * * *
``As I said, the policy seems to be working. So this
indicates that on this particular factor, this policy is
moving us in an upward direction towards--it's a positive
thing.''
In rejecting a statement of preference for thimerosal-free
vaccines, the Advisory Committee considered a number of
factors. These included a desire to avoid confusion, and a
concern that immunization rates might fall, allowing for an
outbreak of diseases such as Pertussis or Hepatitis B.
However, one of the factors that were also considered was the
financial health of the vaccine industry. In describing the
pros and cons of each option, Dr. Bernier returned several
times to financial issues:
``We think that having this type of a more staged
transition reduces the potential for financial losses of
existing inventories, and is somewhat akin to what was done
in the transition from oral polio to inactivated polio . .
.''
* * * * *
``It could entail financial losses of inventory if current
vaccine inventory is wasted. It could harm one or more
manufacturers and may then decrease the number of
suppliers.''
* * * * *
``The evidence justifying this kind of abrupt policy change
does not appear to exist, and it could entail financial
losses for all existing stocks of vaccines that contain
thimerosal.''
The financial health of the industry should never have been
a factor in this decision. The financial health of vaccine
manufacturers certainly should never have been more important
to the Federal health officials than the health and well
being and the nation's children. The CDC has a responsibility
to protect the health of the American public. If there were
any doubts about the neurological effects of ethylmercury in
vaccines on children--and there were substantial doubts--the
prevailing consideration should have been how best to protect
children from potential harm. However, it appears that
protecting the industry's profits took precedent over
protecting children from mercury damage.
In opting not to state a preference for thimerosal-free
vaccines, the Advisory Committee shrugged off two sensible
proposals that were presented during the meeting. A
representative of SmithKline Beecham (now GlaxoSmithKline)
stated that her company could supply sufficient amounts of
thimerosal-free DTaP vaccine to ensure that the youngest
infants receiving the initial doses of DTaP could receive
thimerosal-free doses:
``I think it's important that you know that, although we
cannot supply the entire U.S. market right now for all five
doses immediately, we would be able to supply the vast
majority of the U.S. market for the primary series, that is
with targeting of the first three doses.''
Given the repeated concerns expressed about the effects of
mercury on the developing central nervous system in very
young babies, ensuring thimerosal-free doses for the first
three boosters of DTaP would seem to merit serious
consideration. However, this suggestion was passed over
without any comment.
Later in the discussion, Dr. Neal Halsey made another
suggestion that would limit the exposure of infants to
ethylmercury. He suggested that the Advisory Committee adopt
a policy that no child should receive more than one
thimerosal-containing vaccine per day:
``Roger, you said that after July, the maximum exposure
will be 75 micrograms. My understanding from the information
presented from the manufacturers is that there really still
is some Hib out there in the market that is being used, but
does contain thimerosal as a preservative. There also is
hepatitis B out there that does contain it. So there's no
guarantee the maximum exposure would be 75 micrograms. What I
proposed last October was that they put a limit of one
thimerosal-containing vaccine as a preservative per visit,
which would then guarantee what you're looking for. And I
think that that's the right policy because that allows for
the continued use, though very limited. It eliminates the
maximum exposure, but you do have the problem of what's in
the pipeline.''
Again, it appears that this seemingly sensible proposal
received no serious consideration.
One year later, in June of 2001, the Advisory Committee
again rejected the idea of expressing a preference for
thimerosal-free vaccines, despite the fact that all
manufacturers of Hib, Hepatitis B and DTaP had shifted to
thimerosal-free products at that point. The CDC's decision
not to express a preference for thimerosal-free vaccines, and
the Advisory Committee's concurrence in this policy, was an
abdication of their responsibility. As a result of their
inaction, children continued to receive vaccinations
containing ethylmercury at a time when there were serious
doubts about its safety.
[[Page E1028]]
What makes the CDC's decision even more vexing is that just
prior to the Advisory Committee meeting in 2000, a study
conducted by the CDC suggested that there was at least a weak
correlation between exposure to thimerosal and several types
of neurological disorders.
The study, initiated in 1999, reviewed the medical records
of 110,000 children in the CDC's Vaccine Safety Datalink
(VSD). The VSD is a massive database that tracks the medical
records of hundreds of thousands of patients belonging to
seven major health maintenance organizations. Phase I of the
study was designed to screen data for potential
associations between thimerosal-containing vaccines and
selected neurological disorders. Phase II was designed to
test the hypotheses generated in the first phase.
Phase I produced a statistically-significant association
between exposure to thimerosal during the first three months
of life, and tics, attention deficit disorder, language and
speech delays, and general neurodevelopmental delays. The
study did not find a correlation between thimerosal and
autism because the sample size of children diagnosed with
autism was in all probability not large enough.
The findings of Dr. Verstraeten, the primary author of the
study, set off a fierce debate within the Federal health
agencies when they were released in June of 2000. Enough
concern was generated that a conference of medical experts
was assembled at the Simpsonwood Retreat Center near Atlanta.
At this conference, Dr. Verstraeten explained that the study
underreported the numbers of children with developmental
disorders, including autism. This occurred because the
youngest subjects in the study were not yet at an age at
which such disorders were likely to be diagnosed. He
commented:
``But one thing that is for sure, there is certainly an
under-ascertainment of all of these [disorders] because some
of the children are just not old enough to be diagnosed. So
the crude incidence rates are probably much lower than what
you would expect because the cohort is still very young.''
Dr. Colleen Boyle of the CDC raised this issue a few months
earlier. She states in an April 25, 2000, e-mail to Dr. Frank
DeStefano, one of the study's co-authors:
``For me, the big issue is the missed cases--and how this
relates to exposure. Clearly there is a gross
underreporting--1.4% of the kids dignosed with a speech and
language problem versus 4-5% reported in National surveys;
less than 1% with ADHD versus 3-10% reported previously,
etc.''
Had the study been extended until these children were
older, a stronger correlation between thimerosal and
neurological disorders might have been detected, as more
children were diagnosed. However, this was not done.
Ultimately, the majority of the Simpsonwood panel determined
that the VSD study was not conclusive. Phase II of the VSD
study failed to confirm the findings of Phase I, largely
because of the small sample size employed (16,000, as opposed
to 110,000 in Phase I). The Institute of Medicine determined
that, ``the small sample size limited the power of the study
to detect a small effect, if it exists. The committee
concludes that the Phase I and II VSD analyses are
inconclusive with respect to causality.''
Although the panel assembled at the Simpsonwood Retreat
Center had many unanswered questions about the VSD study,
some members found the evidence compelling. Dr. David
Johnson, Public Health Officer for the state of Michigan and
a member of the Advisory Committee on Immunization Practices
stated:
``This association leads me to favor a recommendation that
infants up to two years old not be immunized with Thimerosal-
containing vaccines if suitable alternative preparations are
available . . . I do not believe that the diagnoses justifies
compensation in the Vaccine Compensation Program at this
point. I deal with causality, it seems pretty clear to me
that the data are not sufficient one way or the other. My gut
feeling? It worries me enough. Forgive this personal comment,
but I got called out at eight o'clock for an emergency call
and my daughter-in-law delivered a son by C-Section. Our
first male in the line of the next generation, and I do not
want that grandson to get a Thimerosal-containing vaccine
until we know better what is going on. It will probably take
a long time. In the meantime, and I know that there are
probably implications for this internationally, but in the
meantime I think I want that grandson to only be given
Thimerosal-free vaccines.''
One participant in the Simpsonwood panel later stated that,
while there was general agreement that the VSD study did not
prove a causal relationship between thimerosal and
neurological disorders, it did indicate the need for much
more research:
``So what were the responses of the consultants? With
regard to the first question, a need for further
investigation. Overall the group expressed unanimous feeling
that the findings supported a statistically significant,
although weak, association, but that the implications--for
obvious reasons--are profound. Therefore, the consultants
were unanimous in their opinion that further investigation
should be pursued with a degree of urgency and,
parenthetically, not only for public health policy in this
country, but for public health policy around the world.''
Documents reviewed by the Committee indicate that Dr.
Verstraeten was not pleased with the response to his study.
During the Simpsonwood conference, he stated:
``When I saw this, and I went back through the literature,
I was actually stunned by what I saw--because I thought it
was plausible.''
A month later, he sent an e-mail to Dr. Phillippe
Grandjean, the author of several groundbreaking studies on
the toxicity of mercury. Dr. Verstraeten wrote:
``I know that much of this is very hypothetical and,
personally, I would rather not drag the Faroe and Seychelles
studies into this entire thimerosal debate, as I think they
are as comparable as apples and pears at the best.
Unfortunately I have witnessed how many experts, looking at
this thimerosal issue, do not seem bothered to compare apples
to pears and insist if nothing is happening in these studies,
then nothing should be feared of thimerosal. I do not wish to
be the advocate of the anti-vaccine lobby and sound as if I
am convinced that thimerosal is or was harmful; but at least
I feel we should use sound scientific argumentation, and not
let our standards be dictated by our desire to disprove an
unpleasant theory.''
It appears that many who participated in the thimerosal
debates allowed their standards to be dictated by their
desire to disprove an unpleasant theory. The decision by the
CDC not to state a preference for mercury-free vaccines is
especially difficult to understand, given the deep-seated
concerns many policy-makers had about the potential impact of
ethylmercury on the fragile central nervous systems of
developing babies. FDA officials spoke passionately about
this problem at a meeting of the National Vaccine Advisory
Committee in the summer of 1999. Dr. Katherine Zoon stated:
``We need to understand more about thimerosal because in
the past two days, I think we have recognized that there
really is a paucity of data, And I think some of the points
made about looking at the developing nervous system, looking
at the developing immune systems, and the effects of these
agents on that at critical times of development, hasn't
been--hasn't been done--and I think that knowledge is very
important.''
At the same meeting, Dr. Bernard Schwetz, the Director of
the FDA's toxicology center, stated:
``. . . the sensitivity of the fetus versus the neonate is
very important, and for some of you who have forgotten about
the sensitive windows during fetal development, the nervous
system develops post-natally. So it isn't unreasonable to
expect that there would be particular windows of sensitivity.
So it isn't the matter of averaging the dose over the whole
neonatal period--it's what's the week or what's the day or
what's the series of hours that represent a particular event
in the development of the nervous system when this whole
thing might be dangerous. There may be weeks surrounding that
when there isn't a major problem. We don't have that
information.''
VIII. Focused, Intensive Research Effort is Badly Needed
One of the most consistent refrains heard by the Committee
throughout its three-year investigation is that not enough
research has been done. The Committee has heard testimony
from parents, scientists and government officials that much
more research is needed, and that well-designed unbiased
research that addresses the specific issues of vaccine-injury
must be conducted. Areas in which research is urgently needed
include:
The causes of autism.
Treatments for those suffering from autism spectrum
disorders.
Possible relationships between vaccine ingredients like
thimerosal and autism.
The neurotoxicity of ethylmercury.
The neurotoxicity of dental amalgams containing mercury.
Immune system and gastrointestinal system dysfunction after
vaccination.
In 2001, the Institute of Medicine called for much more
research into possible relationships between vaccines and
autism spectrum disorder. In its report on an alleged
relationship between the MMR vaccine and autism, the IOM
noted that it ``does not exclude the possibility that MMR
vaccines could contribute to ASD'' and recommended ``this
issue receive continued attention.'' The IOM made the
following research recommendations:
Use accepted and consistent case definitions and assessment
protocols for ASD (autism spectrum disorder) in order to
enhance the precision and comparability of results from
surveillance, epidemiological, biological investigations.
Explore whether exposure to MMR vaccine is a risk factor
for ASD in a small number of children.
Develop targeted investigations of whether or not measles
vaccine-strain virus is present in the intestines of some
children with ASD.
Encourage all who submit reports to VAERS of any diagnosis
of ASD thought to be related to MMR vaccine to provide as
much detail and as much documentation as possible.
Case Reports in VAERS or elsewhere of ``rechallenge''
should be identified, documented, and followed up. (In the
context of MMR vaccine and ASD, rechallenge refers to
children who appeared to have experienced some form of
neurological regression after a first dose of MMR or other
measles-containing vaccine and who appeared to have
experienced another regression following a second dose of MMR
or other measles-containing vaccine.)
Study the possible effects of different MMR immunization
exposures.
[[Page E1029]]
Conduct further clinical and epidemiological studies of
sufficient rigor to identify risk factors and biological
markers of ASD in order to better understand genetic or
environmental causes.
In its report on thimerosal-containing vaccines and autism,
the IOM stated that there was not enough evidence to reach
any conclusions about a possible relationship between
thimerosal and autism spectrum disorders. The IOM called for
the following types of research:
Case-control studies examining the potential link between
neurodevelopmental disorders and thimerosal-containing
vaccines;
Further analysis of cohorts of children who did not receive
thimerosal-containing doses of vaccines during clinical
trials;
Epidemiological studies comparing the prevalence of
neurological disorders in children who received vaccines
before thimerosal was removed to children who received
vaccines after it was removed;
An increased effort to identify the primary sources and
levels of prenatal and postnatal exposure to thimerosal;
Clinical research on how children metabolize and excrete
metals;
Theoretical modeling of ethylmercury exposures, including
the incremental burden of thimerosal on background mercury
exposures from other sources;
Research in appropriate animal models on neurodevelopmental
effects of ethylmercury;
Rigorous scientific investigations of chelation as a
treatment for neurodevelopmental disorders; and
Research to identify a safe, effective and inexpensive
alternative to thimerosal for countries that decide they want
to follow the example of Europe and the United States and
discontinue its use.
One concern that has been raised many times is that
responsibility for research into autism and related issues at
the NIH has been fragmented. Responsibility is divided among
the National Institute of Mental Health, the National
Institute of Neurological Diseases and Stroke, the National
Institute of Child Health and Human Development, and the
National Institute of Environmental Health Sciences. Greater
overall coordination is needed. The NIH needs to develop a
strategic plan on autism research to bring together the
diverse activities, develop a strategy and timeline, and
focus research on the most pressing research needs.
Another concern is the lack of a sufficient investment into
research on autism and its causes. Autism is growing at
epidemic proportions and nobody knows why. The rates of
autism doubled during the Committee's investigation, yet
funding for research on autism lags badly behind funding for
other serious diseases. The NIH, with a budget of $27 Billion
dollars last year, invested just $56 Million towards autism
research. Much of that research has been focused on looking
for genetic causes of autism, which is important, but does
not address the possible connection to vaccine injury. To put
the spending on autism in perspective, the Committee compared
it to the spending on two other serious epidemics--HIV/AIDS
and diabetes. At the same time that the NIH was spending $56
Million on autism research, they spent $688 Million on
diabetes research and over $2.2 Billion on HIV/AIDS research.
The Centers for Disease Control and Prevention has also
been negligent in addressing the research needs regarding
vaccine injury and a connection to the autism epidemic. In FY
2002, the CDC invested $11.3 Million on autism, while
spending $62 Million on diabetes, and $932 Million on HIV/
AIDS. With spending for autism 80 times less than that for
AIDS, it is obvious that CDC is not addressing the autism
epidemic with enough rigor. Instead, at the time of the
Committee's April 2002 hearing, the CDC actually planned to
cut autism research spending to $10.2 Million.
Of additional concern has been the CDC's bias against
theories regarding vaccine-induced autism. Rather than
aggressively work to replicate clinical findings with
laboratory data that showed a relationship between vaccines
and autism, (the Wakefield autism entercolitis studies), the
CDC funded researchers who also worked for vaccine
manufacturers to conduct population-based epidemiological
studies to look at the possible correlation between vaccine
injury and a subset of the population that might be injured.
The CDC to date has relied too heavily on epidemiological
findings. While epidemiological studies are important, they
are not a substitute for focused, clinical research.
Chairman Burton expressed some of these concerns at the
June of 2002 hearing:
``Officials at HHS have aggressively denied any possible
connection between vaccines and autism. They have waged an
information campaign endorsing one conclusion on an issue
where the science is still out. This has significantly
undermined public confidence in the career public service
professionals who are charged with balancing the dual roles
of assuring the safety of vaccines and increasing
immunization rates. Increasingly, parents come to us with
concerns that integrity and an honest public health response
to a crisis have been left by the wayside in lieu of
protecting the public health agenda to fully immunize
children. Parents are increasingly concerned that the
Department may be inherently conflicted in its multiple roles
of promoting immunization, regulating manufacturers, looking
for adverse events, managing the vaccine injury compensation
program, and developing new vaccines. Families share my
concern that vaccine manufacturers have too much influence as
well. How will HHS restore the public's trust?''
It is clear that inadequate scientific evidence exists to
understand fully the likely damage done to a generation of
children who were repeatedly exposed to significant levels of
mercury through their mandatory childhood immunizations.
While the use of safe and effective vaccines for dangerous
infectious diseases is very important, the lack of quality
data addressing the risk of adverse reactions to vaccines and
their components undermined public support for this important
public health tool.
IX. Conclusions
It is obvious from all accounts that there is a crisis in
the United States regarding the dramatic rise in autism rates
and the resulting strain placed on families, the education
system, and State Medicaid and disability programs. A further
crisis will ensue in the next two decades when we see an
explosion in the need for adult services and long-term
housing.
In a further attempt to raise the level of awareness of the
autism epidemic, in November of 2002, Chairman Burton called
upon the President to announce a White House Conference on
autism to ``galvanize a national effort to determine why
autism has reached epidemic proportions in this country.''
Chairman Burton suggested this would be a valuable
opportunity to ``bring together the best minds from across
the country to chart a course of scientific research to
uncover the underlying causes of this epidemic. . . Mr.
President, you are in a unique position to provide the
leadership that is necessary to organize a national effort to
resolve these problems.'' In January of 2003, the response
from Bradley A. Blakeman, Deputy Assistant to the President
and Director of Appointments and Scheduling was, ``I do not
foresee an opportunity to add this event to the calendar.''
It is unfortunate that the request of the Chairman, and the
hundreds of families who personally appealed to the White
House for this Conference did not appear to have been brought
to the personal attention of the President, who has stated
that ``no child shall be left behind.''
Vaccines are the only medicines that American citizens are
mandated to receive as a condition for school and day care
attendance, and in some instances for employment.
Additionally, families who receive Federal assistance are
required to show proof that their children have been fully
immunized. While the mandate for which vaccines must be
administered is a State mandate, it is the Federal
Government, through the Centers for Disease Control and
Prevention (CDC) and its Advisory Committee for Immunization
Practices that make the Universal Immunization
Recommendations to which the States refer for determining
mandates. Federal programs and funding to State programs
provide immunizations free-of-charge to many children. In
July of 2000, it was estimated that 8,000 children a day were
being exposed to mercury in excess of Federal guidelines
through their mandatory vaccines. Given the importance of
vaccination in our overall public health strategy, it is
imperative that the Department of Health and Human Services
adequately addresses the concerns of families of whose
children have possible vaccine-induced autism. The
continued response from agency officials that ``there is
no proof of harm'' is a disingenuous response. The lack of
conclusive proof does not mean that there is no connection
between thimerosal and vaccine-induced autism. What the
lack of conclusive proof indicates is that the agency has
failed in its duties to assure that adequate safety
studies were conducted prior to marketing. Furthermore, in
the last two decades, after determining that thimerosal
was no longer ``generally recognized as safe'' for topical
ointments, the agency did not extend their evaluation to
other applications of thimerosal, in particular as a
vaccine preservative.
One leading researcher made the following statement to the
Committee in July of 2000: ``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.''
The Food and Drug Administration's (FDA) mission is to
``promote and protect the public health by helping safe and
effective products reach the market in a timely way, and
monitoring products for continued safety after they are in
use.'' However, the FDA uses a subjective barometer in
determining when a product that has known risks can remain on
the market. According to the agency, ``at the heart of all
FDA's product evaluation decisions is a judgment about
whether a new product's benefits to users will outweigh its
risks. No regulated product is totally risk-free, so these
judgments are important. FDA will allow a product to present
more of a risk when its potential benefit is great--
especially for products used to treat serious, life-
threatening conditions.''
This argument--that the known risks of infectious diseases
outweigh a potential risk of neurological damage from
exposure to thimerosal in vaccines--is one that has
continuously been presented to the Committee by government
officials. FDA officials have stressed that any possible risk
from thimerosal was theoretical, that no proof of harm
[[Page E1030]]
existed. However, the Committee, upon a thorough review of
the scientific literature and internal documents from
government and industry, did find evidence that thimerosal
did pose a risk.
Thimerosal used as a preservative in vaccines in likely
related to the autism epidemic. This epidemic in all
probability may have been prevented or curtailed had the FDA
not been asleep at the switch regarding the lack of safety
data regarding injected thimerosal and the sharp rise of
infant exposure to this known neurotoxin. Our public health
agencies' failure to act is indicative of institutional
malfeasance for self-protection and misplaced protectionism
of the pharmaceutical industry.
____________________