Dan Burton Congress Report 2001

Mercury in Medicine
Taking Unnecessary Risks
A Report Prepared by the Staff of the

Subcommittee on Human Rights and Wellness
Committee on Government Reform
United States House of Representatives
Chairman Dan Burton
May 2003
(This Report Is the Result of a Three Year Investigation

Initiated in the Committee on Government Reform.)
Mercury in Medicine – Taking Unnecessary Risks
Table of Contents
I. EXECUTIVE SUMMARY .......................................................................................... 3
II. FINDINGS AND RECOMMENDATIONS ............................................................... 6

A. FINDINGS ......................................................................................................................... 6
B. RECOMMENDATIONS ........................................................................................................ 8
III. THIMEROSAL HAS BEEN USED IN VACCINES AND OTHER
MEDICAL PRODUCTS FOR DECADES ................................................................................. 9
A. A BRIEF DESCRIPTION OF MERCURY ............................................................................... 9
B. THIMEROSAL, WHICH CONTAINS ETHYLMERCURY, HAS BEEN USED I N
MEDICINES SINCE THE 1930’S. ...................................................................................... 10
C. MERCURY IS A KNOWN NEUROTOXIN, BUT M ETHYLMERCURY HAS BEEN M ORE
CAREFULLY STUDIED THAN ETHYLMERCURY................................................................ 11
D. BECAUSE OF ITS TOXICITY, M ERCURY HAS BECOME HEAVILY REGULATED . ............... 17
1. The EPA Is Regulating the Release of Mercury Into The Environment ....................... 17
2. Different Limits To Exposure To Mercury have Been Established By Different
Agencies ................................................................................................................................ 18
3. Warnings Have Been Issued About Mercury In Seafood.............................................. 20
4. Over the Course of Two Decades, the FDA Slowly Removed Ethylmercury
From Many Medicinal Products. .......................................................................................... 22
E. THIMEROSAL IS STILL USED IN SOME MEDICAL P RODUCTS .......................................... 24
IV. THERE ARE GROWING QUESTIONS ABOUT WHETHER
MERCURY IN CHILDHOOD VACCINES IS RELATED TO AUTISM
SPECTRUM DISORDERS........................................................................................................ 27
A. AUTISM IS GROWING AT EPIDEMIC PROPORTIONS ......................................................... 27
1. Introduction................................................................................................................... 27
2. Studies Are Documenting the Incredible Growth of Autism......................................... 28
3. The Causes of the Autism Epidemic Are Not Known.................................................... 29
B. THE ALARMING GROWTH IN AUTISM COINCIDED WITH AN INCREASE IN THE
NUMBER OF CHILDHOOD VACCINES CONTAINING THIMEROSAL ON THE
RECOMMENDED SCHEDULE. .......................................................................................... 31
V. VALID CONCERNS ABOUT MERCURY IN VACCINES WERE
IGNORED BY FEDERAL POLICYMAKERS AND VACCINE
MANUFACTURERS FOR DECADES .................................................................................... 34
A. MANY PARENTS OF AUTISTIC CHILDREN BELIEVE THAT ADVERSE REACTIONS
TO VACCINES ARE RESPONSIBLE FOR THEIR CHILDREN ’S CONDITION ........................... 38
B. MANY PARENTS OF AUTISTIC CHILDREN HAVE FILED PETITIONS FOR
COMPENSATION OR LAWSUITS AGAINST VACCINE MANUFACTURERS. ............................ 41
VI. A GROWING NUMBER OF SCIENTISTS AND DOCTORS BELIEVE

THAT A RELATIONSHIP BETWEEN THIMEROSAL IN VACCINES AND
AUTISM SPECTRUM DISORDERS IS PLAUSIBLE .......................................................... 43
1
A. Introduction................................................................................................................... 43
B. Institute of Medicine Reports Call for More Research................................................. 44
C. A Growing Number of Researchers Believe That There May be a Relationship
Between Vaccines and Autism Spectrum Disorders ............................................................ 46
D. PUBLIC HEALTH OFFICIALS CONTINUE TO DEFEND THE USE OF THIMEROSAL IN
VACCINES ...................................................................................................................... 50
E. Research on the Effects of Thimerosal Has Been Too Limited to Draw
Conclusions. .......................................................................................................................... 53
VII. EVIDENCE OF ETHYL MERCURY’S TOXICITY WAS NEGLECTED
BY MANUFACTURERS AND FEDERAL REGULATORS FOR YEARS. ....................... 56
A. INTRODUCTION .............................................................................................................. 56
B. THIMEROSAL MANUFACTURERS ACCUMULATED EVIDENCE OF THE TOXICITY OF
THIMEROSAL.................................................................................................................. 57
C. THE FDA WAS PAINFULLY S LOW TO REQUIRE THE REMOVAL OF MERCURY
FROM OVER- THE-COUNTER (OTC) P RODUCTS.............................................................. 60
D. THE FDA’S ACTIONS TO REMOVE MERCURY FROM OVER- THE- COUNTER
PRODUCTS SHOULD HAVE PROMPTED A REVIEW OF MERCURY IN VACCINES . .................. 62
E. FEDERAL REGULATORS MOVED TOO S LOWLY TO REMOVE THIMEROSAL FROM
VACCINES . ..................................................................................................................... 62
VIII. FOCUSED, INTENSIVE RESEARCH EFFORT IS BADLY NEEDED.............. 74
IX. CONCLUSIONS ......................................................................................................... 78
2
I. Executive Summary
Vaccines are the only medicines that American citizens are mandated to receive
as a condition fo r 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-1990’s, 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. 1 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, Thimerosal2 , 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. 3
1
The Subcommittee on National Security, Veterans Affairs, and International Relations under the Chairmanship of
Congressman Christopher Shays investigated the Department of Defense’s Anthrax Vaccine Immunization Program
resulting in the Committee’s report, “Department of Defense Anthrax Vaccine Program: Unproven Force
Protection” [House Report 106-556]. The Subcommittee on Criminal Justice, Drug Policy, and Human Resources
under the Chairmanship of Congressman John Mica investigated the concerns about the safety of the Hepatitis B
vaccine and traversing the National Vaccine Injury Compensation Program, resulting in the publication of the report
“The Vaccine Injury Compensation Program, Addressing Needs and Improving Practices” [House Report 106-977].
2
Thimerosal is referred to as thiomersal in the United Kingdom and in some medical literature.
3
“Mercury in Medicine – Are We Taking Unnecesary Risks?” Hearing Before the Committee on Government
Reform; 106th Congress; July 18, 2000; pages 3 & 4; Serial No. 106-232 (Opening Statement of Chairman Dan
Burton)
3
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.4
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.”5 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.”6
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.
4
Reform; 106th Congress; July 18, 2000; page 212 ; Serial No. 106-232 (Testimony of Dr. H. Vasken Aposhian,
Professor of Molecular and Cellular Biology, and Pharmacology, University of Arizona)
5
About the US Food and Drug Administration, http://www.fda.gov/opacom/hpview.html
6
FDA Overview: Protecting Consumers – Protecting Public Health;
http://www.fda.gov/oc/opacom/fda101/fda101text.html, and http://www.fda.gov/oc/opacom/fda101/sld007.html
4
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. 7
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
7
The FDA defines “trace amounts” of ethylmercury as less than 1 microgram.
5
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 hypoallergenicity 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 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.
6
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.
7
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.”8 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
8
Agency for Toxic Substances and Disease Registry (ASTDR), Public Health Statement for Mercury , CAS# 7439-
97-6, March 1999.
8
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 Synd rome, 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 silent ly 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. 9
9
9
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 lead 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.10
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.11
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:
10
http://www.atsdr.cdc.gov/tfacts46.html
11
http://search.biography.com/print_record.pl?id=16530
10
“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.” 12
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 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.”13
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 consens us very succinctly:
12
13
ELC002239-57; Rosenstein, Carolyn et.al.; “The Bactericidal and Antiseptic Action of Preservatives Frequently
Used in Biological Products, and the Effect of these Preservatives on the Potencies of These Products;” The
American Journal of Hygiene; September 31, 1934.
11
“Mercury and its compounds are cumulative toxins and in small quantities are
hazardous to human health.”14
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.”15
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,16 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
14
Cyr Patrick J, Suri Rominder PS, Helmig Edward D, “A Pilot Scale Evaluation of Removal of Mercury From
Pharmaceutical Wastewater Using Granular Activated Carbon,” Water Research 36; pages 4725-4734; 2002
15
Clarkson, Thomas W ; “The Three Modern Faces of Mercury,” Environmental Health Perspectives; Volume 110,
Supplement 1, pages 11-13; February 2002
16
http://www.nap.edu/books/0309071402/html/
12
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.” 17
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 18
Additionally, elevation in both systolic and diastolic blood pressure in seven year olds
correlated with prenatal exposure to methylmercury…indicative of later cardiovascular
problems. 19
17
Clarkson, Thomas W ; “The Three Modern Faces of Mercury,” Environmental Health Perspectives; Volume 110,
Supplement 1, pages 11-13; February 2002
18
Id, pages 11-23
19
Id, pages 11-23
13
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 stud y: “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.”20 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
ethylmercur y. Thus, when facing a policy decision on thimerosal and vaccines, the FDA had to
work from an “assumption”21 that the toxicity of ingested methylmercury was the same as
injected ethylmercury. 22
20
ELC002353-67; Rosenstein, Carolyn et.al.; “The Bactericidal and Antiseptic Action of Preservatives Frequently
Used in Biological Products, and the Effect of these Preservatives on the Potencies of These Products;” The
American Journal of Hygiene; September 31, 1934.
21
PowerPoint Presentation of William Egan, FDA dated September 14, 1999
http://www.fda.gov/ohrms/dockets/ac/99/backgrd/3544b1f.pdf
22
It should be noted that it is widely accepted in toxicology that the level of exposure to a toxin through injection
which would create an adverse reaction would be much lower than the level of exposure needed to create a similar
reaction through ingestion.
14
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.”23 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
were more widely spread in ethylmercury-treated rats.” 24
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 25 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
23
L. Magos, et al, “The Comparative Toxicology of Ethyl - and Methylmercury; Archives of Toxcicology; 1985
57:260-267
24
Id
25
David Baskin, M.D., Professor of Neurosurgery and Anesthesiology, Baylor College of Medicine, Houston,
Texas.
15
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.”26
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. “27
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.”28
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
26
“Vaccines and the Autism Epidemic: Reviewing the Federal Government’s Track Record and Charting a Course
for the Future;” Heairng Before the Committee on Government Reform; 107th Congress; December 10, 2002; pages
116-117; Serial No. 107.153; (Dialogue between Congressman Dave Weldon and Dr. David Baskin).
27
“Vaccines and the Autism Epidemic: Reviewing the Federal Government’s Track Record and Chart ing a Course
for the Future;” Heairng Before the Committee on Government Reform; 107th Congress; December 10, 2002; pages
116-117; Serial No. 107.153; (Dialogue between Congressman Dave Weldon and Dr. David Baskin).
28
16
National Institute of Environmental Health Sciences, National Institutes of Health, Dr. George
Lucier, proffered the following conclusions:
Ø Ethylmercury is a neurotoxin.
Ø Infants may be more susceptible than adults.
Ø Ethylmercury should be considered equipotent to methylmercury as a
developmental neurotoxin. This conclusion is clearly public health
protective.
Ø Ethylmercury exposure from vaccines (added to dietary exposures to
methylmercury) probably caused neurotoxic responses (likely subtle) in
some children. 29
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.” 30
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, 31 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
29
http://www.iom.edu/iom/iomhome.nsf/WFiles/Lucier/$file/Lucier.pdf
30
“The Status of Research Into Vaccine Safety and Autism”; Hearing Before the Committee on Government
Reform; 107th Congress; June 19, 2002; page 58; Serial No. 107-121; (Testimony of Dr. Jeffrey Bradstreet)
31
"Mercury," World Book Online Americas Edition,
http://www.aolsvc.worldbook.aol.com/ar?/na/ar/co/ar356220.htm, January 5, 2003.
17
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.”32
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
2018.33 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. 34
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 ma rked 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. 35
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.”36
32
http://www.epa.gov/ttn/oarpg/t3/fact_sheets/fs_util.pdf
33
http://www.whitehouse.gov/news/releases/2002/02/20020214.html
34
http://www.epa.gov/grtlakes/bns/
35
Freed Gary L,et al; “Vaccine Safety Policy Analysis in Three European Countries: The Case of Thimerosal”,
Health Policy, 62; pages 291-307;2002.
36
http://www.nap.edu/books/0309071402/html/
18
Methylmercury Guidelines
Agency Guideline Value for maximum Guideline ‘Type’
Daily Consumption
(µg/kg/day)
(Micrograms 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.”37
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.”38
According to the analysis of Dr. McKee, based on the methylmercury ingestion

guidelines, the Chairman’s grandson would have exceeded the “ten times the MRL” and
37
Grand Rounds materials of Dr. Roberta McKee, Merck, B12949
38
Reform; 106th Congress; July 18, 2000; page 2; Serial No. 106-232 (Opening Statement of Chairman Dan Burton)
19
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.”39
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
39
Canadian Communicable Disease Report, Vol. 28, No. 9;page 76; 1 May 2002.
20
FDA experts to limit their consumption of shark and swordfish to no more than
once a month.”40
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.” 41
In addition to the public advisories, the FDA, in January of 2001, established an

aggressive “Education Plan on Methyl Mercury.”42 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.”43
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.” 44
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
40
Mercury in Fish: Cause for Concern; FDA Advisory; September 1994;
http://www.fda.gov/fdac/reprints/mercury.html
41
FDA Consumer Advisory, March 2001 http://www.cfsan.fda.gov/~dms/admehg.html
42
http://www.fda.gov/OHRMS/DOCKETS/ac/02/briefing/3872_Advisory%206.pdf
43
http://www.cfsan.fda.gov/~acrobat/hgcong82.pdf
44
FDA’s Chapter 14, Metals Analysis Training http://www.fda.gov/ora/science_ref/lpm/lpchtr14.html
21
gastrointestinal toxicity. Organic compounds of mercury such as methylmercury
are considered the most toxic forms of the element. Exposures to v ery 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.45
“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.” 46
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. 47
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
45
http://www.nih.gov/od/ors/ds/nomercury/health.htm
46
http://www.nih.gov/od/ors/ds/nomercury/
47
http://www.ors.od.nih.gov/ds/nomercury/BethesdaInputv1.cfm
22
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. 48
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 49 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:
Ø 10 % of school children
Ø 16% of military recruits
Ø 18% of twins, and
Ø 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.”50
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
48
47 FR 436, January 5, 1982 Advance Notice of Proposed Rulemaking Regarding Thimerosal
49
Id.
50
Id.
23
challenge the findings of the Panel regarding the toxicity of thimerosal in OTC products. 51 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
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.”52
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.
51
Federal Register Notice: April 22, 1998 (Vol. 63, N. 77)
52
http://www.fda.gov/cber/vaccine/thimerosal.htm#intro
24
• 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 53
Vaccine # 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), 0 (or 0.5 mcg/dose)
Health Care
Workers, STDs
Influenza 1 Annual 1 1 annual 1 Annual 1 Annual 25 mcg/dose or 24.5
A&B (Health mcg/dose or 1
workers) mcg/dose or .98
mcg/dose
Jap Enceph 3 + biannual N/A N/A 3 + biannual 3 + biannual 35 mcg per 1 mL dose
boosters boosters boosters (Travel or 17.5 mcg/0.5 mL
Rural Asia) dose
MMR 1 1 N/A Seldom NA (Health 0
(Live) needed workers)
Meningococc 1 every 3 years 1 N/A Within 3 Travel to mid- 25 mcg/dose
al MGC years Africa, Arabia
Pneumococca N/A N/A N/A N/A N/A 0
l 7 PCBV-7
Pneumococca 1 1 (Pendleton) N/A N/A (No spleen, 0 or 25 mcg/dose
l 23 PPV-23 other chronic
diseases)
Polio 1 booster dose 1 N/A (Travel Africa 0
Inactivated Asia)
IPV
Rabies Pre:(3 doses + N/A N/A (Veterinary 0
booster) bites)
Smallpox 1 every 10 N/A 1 1 1 0
(Live) years
53
Fax from Lt. Lyn Helnselmen, DOD. (calculations on thimerosal are based on the amounts provided by the FDA
in March 2003.
25
Vaccine # Doses Initial Entry Troops in US Deployed Region or other Thimerosal
Content
Td 1 every 10 1 1 every 10 years 1 every 10 1 every 10 years 8 mcg/dose or 25
years years mcg/dose
TT (25 mcg)
Typhoid 1 every 2 years N/A 1 every 2 days Every 2 years Every 2 years 0
Injectable (travel)
Varicella 2 doses if Screen, 2 doses N/A N/A N/A 0
(Live) needed
Yellow Fever 1 every 10 (N, MC) 1 1 every 10 years 1 every 10 1 every 10 0
(Live) years (travel Africa,
Pacific, South
Am)
Possible 110.5 mcg 135.5 mcg per
Total per shot day shot day
Thimerosal
Exposure
(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

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. 54 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.
54
Captain Frank Schmuck, a decorated Gulf War Veteran has submitted numerous letters to the Committee detailing
his case and the case of numerous vaccine injured Gulf War Veterans. He and his wife filed a lawsuit in the State
of California. http://www.khorrami.com/Cases%20Web/Gulf%20War/Co mplaint%20(2nd%20Amended).pdf
26
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. 55 The Autism Society of America estimates that the
number of autistic children is growing by 10 to 17 percent each year. 56
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.”57
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.58
55
“The Autism Epidemic – Is the NIH and CDC Response Adequate?” Hearing Before the Committee on
Government Reform; 107th Congress; April 18, 2002; pages 6-8 & 32-37; Serial No. 107-74 (Opening Statement of
Congressman Dan Burton and Testimony of Lee Grossman, President, Autism Society of America)
56
Id; pages 32-37; ( Testimony of Lee Grossman, President, Autism Society of America)
57
“Autism: Present Challenges, Future Needs-Why the Increased Rates?” Hearing Before the Committee on
Government Reform; 106th Congress; April 6, 2000; page 4; Serial No. 106-180; (Opening Statement of Chairman
Dan Burton).
58
27
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 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. 59 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). 60 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
1998.61
The main author of the study, Dr. Robert Byrd, said, “It is astounding to see a threefold
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.”62
Reform; 106th Congress; July 18, 2000; page 179; Serial No. 106-232 (Testimony of Dr. Stephanie Cave)
59
Prevalence of Autism in Brick Township, New Jersey, 1998: Community Report
April 2000 http://www.cdc.gov/ncbddd/dd/rpttoc.htm
60
Marshalyn Yeargin-Allsopp, MD;et.al; “Prevalence of Autism in a US Metropolitan Area” ; Journal of
the American Medical Association; 2003; 289; pages 49-55.
61
http://www.dds.cahwnet.gov/autism/pdf/1exec_summ.pdf
62
Study: “CA Child Autism Rates Skyrocket”; October 18, 2002; AP wire,;
http://cbs2.com/content/local_story_1236868523_html/resources_storyPrintableView
28
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 IV63
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.”64
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,
63
Diagnostic and Statistical Manual of Mental Disorders IV Edition
64
“Autism – Why the Increased Rates? A One Year Update”; Hearing Before the Committee on Government
Reform; 107th Congress; April 25-26, 2001; Serial No. 107-29; page17 (Opening Statement of Congressman Henry
Waxman).
29
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. 65
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. 66
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. 67
65
http://www.909shot.com/Diseases/autismsp.htm
66
67
30
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). 68
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. 69
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). 70
68
Powerpoint Presentation “Thimerosal in Vaccines” of William M. Egan, Office of Vaccines Research and
Review, CBER, FDA, dated September 14, 1999
69
Email from Michael Crain, HHS to Beth Clay March 4, 2003
70
Review, CBER, FDA, dated September 14, 1999 and Email from Michael Crain, HHS to Beth Clay, March 4, 2003
31
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. 71
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 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. 72
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. 73 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
71
Email from Michael Crain, HHS to Beth Clay, March 5, 2003
72
http://www.fda.gov/cber/vaccine/thimerosal.htm
73
Review, CBER, FDA, dated September 14, 1999
32
exposed to in 1 day is 1.5 micrograms, so that is 41 times the amount at which
harm can be caused.74
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.” 75
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.’ 76
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
74
Reform; 106th Congress; July 18, 2000; page 2; Serial No. 106-232 (Opening Statement of Chairman Dan Burton)
75
Id. Page 13.
76
33
months, 50 micrograms at 6 months, 50 micrograms at 15 to 18 months; a tot al 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. 77
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’.”78
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.”79
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
77
Reform; 106th Congress; July 18, 2000; pages 179-181; Serial No. 106-232 (Testimony of Dr. Stephanie Cave)
78
Morris Selig Kharasch of College Park Maryland, Applied for Patent for “Alkyl Mercuric Sulphur Compound and
Process for Producing it on June 29, 1927; Serial No. 2002,468. Patent 1,672,615 was issued June 5, 1928.
79
ELC002368-74; Marks, H.H., M.D. et.al.; “Merthiolate as a Skin Discenfectant;” The Journal of Laboratory and
Clinical Medicine; September 1932.
34
that we have tested Merthiolate on humans and find that it gives a more marked local reaction
than does phenol and tricresol.”80
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.”81
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.”82
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 ß-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
80
ELC000546; Letter from the Director of Biological Laboratories of Pitman-Moore Company to W.A. Jamieson,
Director of Biological Division, Eli Lilly and Company (July 22, 1935)
81
ELC002156-61; Ellis, Francis A., M.D. & Robinson, Jarry M., M.D.; “Cutaneous Sensitivity to Merthiolate and
Other Mercurial Compounds;” Archives of Dermatology and Syphliology; 1942
82
ELC002162-3; Ellis, Francis A., M.D.; “Possible Danger in Use of Merthiolate Opthalmic Ointment;” Archives of
Ophthalmology; 1943.
35
chemicals of its generation, data relating to its safety and pharmacological effects
in animal models are sparse.” 83
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…”84
On September 8, 1998, the Safety Working Party of the European Agency for the
Evaluation of Medicinal Products is sued its working paper, “Assessment of the Toxicity of
Thimerosal in Relation to Its Use in Medicinal Products.” The Working Party concluded:
“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.”85
In June of 2000, the CDC convened a closed meeting86 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.” 87
83
ELC000709-10; Letter from William R. Gibson, Director of Toxicology Planning – Eli Lilly to Dr. Alan Blaskett,
Commonwealth Serum Laboratories (Oct. 25, 1978)
84
September 17, 1998 Memorandum from Marion F. Gruber, Ph.D., FDA to Drs. Hardegree and Baylor.
85
B04207-241 ; “Assessment of the Toxicity of Thimerosal in Relation to Its Use in Medicinal Products”’ Safety
Working Party of the European Agency for the Evaluation of Medicinal Products Working Paper; 1998
86
In June of 2000, 53 scientists from the CDC, FDA, ACIP and the pharmaceutical industry met at the
Siimpsonwood Retreat Center in Georgia to review the findings of Dr. Thomas Verstraten regarding a statistically
significant correlation between the receipt of thimerosal-containing vaccines and neurological conditions. The
meeting was not open to the public or announced in the Federal Register. Almost three years later, the CDC has still
not published their findings in a peer reviewed journal.
87
B01257, Comments of Dr. Thomas Verstraeten, CDC. At the Simpsonwood meeting
36
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.”88
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
88
B01257; Statements of Dr. ThomasVerstraeten at the Simpsonwood Meeting.
37
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.”89
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:
89
Reform; 106th Congress; July 18, 2000; pages 228-295; Serial No. 106-232 (Statement of Congresswoman Helen
Chenoweth-Hage)
38
“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 90 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.91
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.”
90
Vaccine Adverse Events Reporting System at the Food and Drug Administration
91
“Autism – Why the Increased Rates? A One Year Update”; Hearing Before the Committee on Government
Reform; 107th Congress; April 25-26, 2001;page 17;Serial No. 107-29; (Testimony of Dr. Jeffrey Bradstreet)
39
..........
“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?” 92
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. 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.”93
92
“Autism: Present Challenges, Future Needs – Why the Increased Rates?”; Hearing before the Committee on
Government Reform; 106th Congress; April 6, 2000; Pg. 6; (Testimony of Shelley Reynolds).
93
Id., Pg. 74, (Testimony of Jeana Smith).
40
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.” 94
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. 95 It has been estimated that as many as 3,000 to 5,000 such
petitions may be filed in the near future. 96
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
94
“The Autism Epidemic – Is The NIH And CDC Response Adequate?”; Hearing Before the Committee on
Government Reform; 107th Congress; April 18, 2002; Pgs. 28-29, 78.
95
Leroy v. Sec. HHS, No. 02-392V; Ruling on jurisdiction by Chief Special Master Gary Golkiewicz; October 11,
2002; Pg. 3.
96
Autism General Order #1, Various Petitioners v. Secretary of Health and Human Services, July 3, 2002, Pg. 2.
41
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. 97
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. 98 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].”99
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.100 Later that year, a group of law firms
calling themselves the “Mercury Vaccine Alliance” filed class action lawsuits in
nine different states.101
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
97
Id., Pgs. 3-4.
98
Id.
99
Master Autism Petition for Vaccine Compensation, Various Petitioners v. Secretary of Health and Human
Services, July 3, 2002.
100
Fisk, Margaret Cronin; “Mercury’s legal morass – A surge of lawsuits allege that vaccinations triggered autism;”
The National Law Journal; March 20, 2002.
101
PR Newswire; “National Legal Alliance Files Multi-State Plea to Protect Generation of Toxic Mercury Overdose
Babies”; October 2, 2001.
42
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. 102 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.103
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.
102
42 USC, 300aa-33(5).
103
See Owens v. American Home Products, et al; and O’Connell v. American Home products, et al; Order of
District Court Judge Samuel Kent; May 7, 2002.
43
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.” 104
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.”105
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. 106 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. 107
104
Institute of Medicine, Immunization Safety Review Committee; “Immunization Safety Review – Measles-
Mumps-Rubella Vaccine and Autism”; April 2001; Pg. 6.
105
Id., Pg. 5.
106
It should be noted that after the IOM publication, that Dr. Wakefield published further research with larger
patient populations further supporting a correlation between low level measles infection in the intestions and the
onset of autism and subsequently entercolitis.
107
Id., Pgs. 4-8.
44
Six months later, the IOM issued its second report, entitled, “Immunization Safety
Review – Thimerosal-Containing Vaccines 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 ex posure 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.” 108
..........
“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.” 109
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. 110
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. 111 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
108
Institute of Medicine, Immunization Safety Review Committee; “Immunization Safety Review – Thimerosal-
Containing Vaccines and Neurodevelopmental Disorders”; October 1, 2001; Pg. 4.
109
Id., Pg. 5.
110
Id.
111
Id.
45
containing mercury be removed from doctor’s offices and replaced with mercury- free
alternatives. 112
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. 113
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
112
Id., Pgs. 8-9.
113
Id., Pgs. 10-12.
46
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.”114
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.”115
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
114
“Autism – Why the Increased Rates? A One-Year Update;” Hearing Before the Committee on Government
Reform; 107th Congress; April 25, 2001, Pg. 136.
115
Id., Pg. 137.
47
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.”116
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.”117
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.”118
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
116
Id.
117
for the Future;” Hearing Before the Committee on Government Reform; 107th Congress; December 10, 2002; Pg.
48.
118
Id., Pgs. 95-96.
48
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 to detoxify the cerebral
spinal fluid may be at least part of the neurological aspect of this disease.” 119
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
119
“Autism – Why the Increased Rates? A One-Year Update;” Hearing Before the Committee on Government
Reform; 107th Congress; April 25, 2001, Pg. 135.
49
are much more sensitive, so there’s a real cause for concern.” 120
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.”121
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:
Ø They asked vaccine manufacturers to remove thimerosal from childhood vaccines

more than three years ago;
Ø 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;
Ø 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.
120
for the Future;” Hearing Before the Committee on Government Reform; 107th Congress; December 10, 2002; Pgs.
52-54.
121
Id., Pgs. 54-55.
50
“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.” 122
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.”123
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.”124
..........
“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.” 125
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.”126
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
122
“The Autism Epidemic – Is the NIH and CDC Response Adequate?”; Hearing Before the Committee on
Government Reform; 107th Congress; April 18, 2002; Pg. 142.
123
Id., Pg. 140.
124
115.
125
Id., Pg. 114.
126
Id., Pg. 115.
51
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.”127
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.”128
127
Allen, Arthur; “The Not-So-Crackpot Autism Theory;” The New York Times Sunday Magazine; November 10,
2002.
128
www.jhsph.edu/Press_Room/Press_Releases/Halsey_autism.html.
52
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.” 129
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 ethylmercury 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. 130 The few studies
that have been performed on ethylmercury have been of limited value, for several reasons.
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
129
Id.
130
Containing Vaccines and Neurodevelopmental Disorders; October 2001; Pgs. 3-4.
53
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 gastrointestinal
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.”131
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.”132
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:
131
for the Future;” Hearing Before the Committee on Government Reform; 107th Congress; December 10, 2002
132
Id.
54
“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.”133
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.”134
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.”135
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
133
51.
134
Id.
135
Id., Pgs. 51-52.
55
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.”136
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.”137
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
136
Id. Pgs. 152-153.
137
Id., Pg. 52.
56
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.”138
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. 139 It is clear today that such a limited number of
subjects, all suffering from the same serious illness, would hardly qualify as a sufficiently sized
138
Containing Vaccines and Neurodevelopmental Disorders; October 2001; Pg. 7.
139
Powell, H.M, and Jamieson, WA, Eli Lilly Laboratoris; “Merthiolate as a Germicide”; American Journal of
Hygeine; 13:296-310; 1931; ELC 002353-67
57
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.” 140
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.” 141
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 j elly
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.” 142
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.”143
An April 1969, memo regarding the possible use of thimerosal in contact lens solution states:
140
Eli Lilly Memorandum from Robert L. Stone to Dr. A. F. Crumley; “Merthiolate in Perenteral Products”
(December 4, 1972) (ELC000110-114)
141
Letter from E. A. Burrows, Eli Lilly Regulatory Affairs Associate to the Food and Drug Administration, Bureau
of Drugs, Regarding Merthiolate (Thimerosal) (February 14, 1973) ELC002125-2471
142
Eli Lilly Memorandum from Retter to Rhodebamel (April 24, 1930) (ELC 002353-67)
143
Paper, Carolyn Rosenstein, Ida Levin (September 21, 1934) (ELC002454-67)
58
“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.” 144
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…” 145
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.”146
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.” 147
144
Eli Lilly Memorandum from W.R. Gibson to Dr. J.M. McGuire regarding Merthiolate and Eye Toxicity (April
15, 1969) (ELC000138)
145
Eli Lilly Memorandum, Robert L. Stone to Dr. A. F. Crumley, “Merthiolate in Parenteral Products”, (December
14, 1972)
146
Eli Lilly Memorandum from W. R. Gibson to M. J. Landes, “Merthiolate Toxcity”, (August 15, 1973)
(ELC000107)
147
Letter from Director of Biological Services, Pittman-Moore Company to W. A. Jamieson, Director of Biological
59
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.”148
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. 149
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.” 150
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. 151
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.”152
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. 153
Division, Eli Lilly, (July 22, 1935) (ELC000546)

148
Francis A. Ellis, MD; “The Sensitizing Factor in Merthiolate;” 18 J. Allergy 212-213 (1947)
149
H.D. Cogswell, MD, et al, “Reaction Following the Use of Tr. Merthiolate,” J. Arizona Med; 42-43 (1948)
150
John H. Brewer, “Mercurials as Antiseptics;” 53 NY Acad Sci; 221-291; (1950).
151
Jones, H.T., “Danger of Skin Burns from Thimerosal;” 2 Brit Med J;505 (1972).
152
Eli Lilly, Product Labeling Committee, (November 16, 1973)
153
Federal Register; Docket No. 75N-0183; “Mercury-Containing Drug Products for Topical Antimicrobial Over-
60
In terms of effectiveness, the panel stated that, “mercury compounds as a class are of
dubious value for antimicrobial use.” They stated that, “mercury inhibits the growth of bacteria,
but does not act swiftly to kill the m.”154 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. 155
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. 156 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. 157
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.”158
Despite the fact that the expert committee found thimerosal and other ethylmercury
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. 159
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, 160 and when
the FDA sought public comment along the way on proposed rules to ban certain mercury-based
products, it received none. 161 At the time of the FDA’s final action, there were 20 over-the-
the-Counter Human Use;” January 5, 1982.

154
Id.
155
Id.
156
Id.
157
Id.
158
Id.
159
Federal Register; Docket Nos. 75N-183F, 75N-183D, and 80N-0280; “Status of Certain Additional Over-the-
Counter Drug Category II and III Active Ingredients – Final Rule;” October 19, 1998.
160
Id.
161
Federal Register; Docket Nos. 75N-183F, 75N-183D, and 80N-0280; “Status of Certain Additional Over-the-
Counter Drug Category II and III Active Ingredients – Final Rule;” October 19, 1998.
61
counter products containing mercury being marketed by eight different manufacturers. 162 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?” 163
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 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. 164
E. Federal Regulators Moved Too Slowly to Remove Thimerosal from Vaccines.
162
Id.
163
Verbatim Transcript; National Vaccine Advisory Committee Sponsored Workshop on Thimerosal Vaccines,
(August 12, 1999), (Comments by Dr. Bernard Schwetz, Senior Science Advisor to the Commissioner of the FDA
and the Director of the FDA National Center for Toxicological Research).
164
21 USC 393, Section 413.
62
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 ethylmercur y. 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 essenc e 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?)” 165
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
165
Email from Dr. Peter Patriarca, Director, Division of Viral Products, Food and Drug Administration, to Martin
Meyers, Acting Director, National Vaccine Program Office, Centers for Disease Control and Prevention.(June 29,
1999) .
63
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; 166 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 Ba ll 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.”167
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.”168
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. 169
166
In Congressional testimony in July 2000, Dr. William Egan, Associate Director of the FDA’s Office of Vaccine
Research and Review, testified that, “there are no guidelines established for ethylmercury, but experts agree that
methylmercury guidelines are appropriate to use in this situation;” “Mercury in Medicine – Are We Taking
Unnecessary Risks?”; Hearing before the Committee on Government Reform; 107th Congress; July 18, 2000.
167
Email from Dr. Marion Gruber, FDA to Dr. Leslie Ball, FDA (October 15, 1998).
168
Email from Dr. Leslie Ball, FDA, to Dr. Marion Gruber, FDA (October 15, 1998)
169
Interview of Dr. Leslie Ball, FDA, November 12, 2002.
64
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. 170
Federal officials have never pub licly 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). 171 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...” 172
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:
170
FDA Pharmacokinetic Charts, June 28, 1999
171
Powerpoint Presentation, “Thimerosal in Vaccines: A Reassessment”, Leslie K. Ball, M.D., DRVPA, OVRR,
Douglas Prattt, M.D., MPH, DVRPA, OVRR, Robert Ball, MD, MPH, MBE (June 22, 1999)
172
Letter to Members of the Committee on Infectious Diseases, American Academy of Pediatrics, from Neal
Halsey, MD (June 23, 1999)
65
“These calculations do not account for other sources of Hg [mercury] in the
environment. Even infants can have additional exposures, e.g., breast milk.”173
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. 174 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. 175
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.”176
In a July 2, 1999, e- mail, Dr. Ruth Etzel of the Department of Agriculture177 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 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.”178
173
Email from Dr. Leslie Ball, FDA to Dr. Normal Baylor, Director of Regulatory Affairs, FDA (July 6, 1999)
174
Powerpoint Presentation, “Thimerosal in Vaccines: A Reassessment”, Leslie K. Ball, M.D., DRVPA, OVRR;
Douglas Prattt, M.D., MPH, DVRPA, OVRR; Robert Ball, MD, MPH, MBE (June 22, 1999)
175
European Agency for the Evaluation of Medicinal Products (EMEA) Safety Working Party A Reassessment,
“Assessment of the Toxicity of Thiomersal in Relation to its Use in Medicinal Products” (September 8, 1988)
176
Email from Dr. Elain Esber, FDA to Linda Suydam, FDA referencing conference call between the American
Academy of Pediatrics, Committee on Infectious Diseases, Committees on Environmental Sciences and Fetal
Neonatal Issues, and Representatives from FDA, CDC, NIH, NVP, Academicians, toxicologists, mercury experts,
etc. (June 29, 1999).
177
Email from Ruth Etzel, US Department of Agriculture to Lauri Hall; Ray Koteras; Hope Hurley; American
Academy of Pediatrics (July 2, 1999).
178
Id.
66
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.” 179
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. 180
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
179
Working Document, EMEA, Multidisciplinary Group on Thiomersal; (June 23, 1999).
180
www.cdc.gov/NIP/vacsafe/concerns/thimerosal/thimerosal-AAP&PHS.htm.
67
thimerosal- free until March of 2000, and Ave ntis Pasteur’s DTaP vaccine did not become
thimerosal- free until March 2001. 181 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. 182
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.”183
181
Records of Meeting; Advisory Committee on Immunization Practice, Centers for Disease Control and
Prevention; June 20-21, 2001; Pg. 27.
182
Id, Pg. 28.
183
Verbatim transcript; Advisory Committee on Immunization Practice, Centers for Disease Control and Prevention;
68
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 …” 184
..........
“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.” 185
..........
“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.”186
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 ens ure 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
June 21, 2000; Pg. 321-324.

184
Id., Pg. 322
185
Id., Pg. 326.
186
Id., Pgs. 327-328.
69
the vast majority of the U.S. market for the primary series, that is with targeting
of the first three doses.”187
Given the repeated concerns expressed about the effects of mercury on the
developing central nervous system in very young babies, ens uring 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.” 188
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.
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
187
Id., Pg. 238, (Statement of Barbara Howe.)
188
Id., Pgs. 336-337, (Statement of Dr. Neal Halsey).
70
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. 189 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.”190
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.”191
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.”192
189
190
Verbatim Transcript, Scientific Review of Safety Datalink Information, June 7-8, 2000, Simpsonwood Retreat
Center, Norcross, Georgia, (“Simpsonwood Meeting”), Page 42.
191
Email from Dr. Colleen Boyle, Assistant Director for Science, Division of Birth Defects, CDC to Dr. Frank
DeStefano, CDC (April 25, 2000)
192
71
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 Michigan193 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.” 194
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.”195
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.” 196
193
While Dr. Johnson identified himself as a state medical officer in the transcrip from the Simpsonwood Meeting,
his official title is “Chief Medical Executive for the Michigan Department of Community Health”
194
Simpsonwood Meeting, Page 198.
195
Verbatim transcript; Advisory Committee on Immunization Practice, Centers for Disease Control and Prevention;
June 21, 2000; Pgs. 309-310.
196
Simpsonwood Meeting, Page 162
72
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.”197
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 policymakers 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.” 198
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.”199
197
Email from Dr. Thomas Vertraeten, CDC to Dr. Phillippe Grandjean (July 14, 2000)
198
Verbatim Transcript; National Vaccine Advisory Committee Sponsored Workshop on Thimerosal Vaccines
(August 12, 1999), (Comments by Dr. Kathryn Zoon, FDA).
199
Id.
73
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:
Ø The causes of autism.

Ø Treatments for those suffering from autism spectrum disorders.
Ø Possible relationships between vaccine ingredients like thimerosal and
autism.
Ø The neurotoxicity of ethylmercury.
Ø The neurotoxicity of dental amalgams containing mercury.
Ø 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 cons istent 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.)200
200
A rechallenge case report is typically considered to carry more weight when looking at a causal link between the
delivery of a vaccine and the onset of an adverse reaction, it eliminates the ‘coincidence’ argument that many put
74
• Study the possible effects of different MMR immunization exposures.
• 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. 201
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. 202
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
forward in saying that the injury - onset of autism - would have happened anyway.)
201
Immunization Safety Review: Measles-Mumps-Rubella Vaccine and Autism pages 55-59, Instittue of Medicine
202
Id., Pgs. 10-12.
75
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 ge netic 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 $2.2 Billion on HIV/AIDS research. 203
NIH Funding for 3 Epidemics ($ in Millions)
FY 2001 FY 2002 FY 2003
845.1
Diabetes 781.3
688.1
2,770
HIV/AIDS 2,515
2,247
70.5
Autism 65.1
55.8
0 500 1000 1500 2000 2500 3000
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. 204
203
“The Autism Epidemic, Is the NIH and CDC Response Adequate?” Hearing Before the Committee on
Government Reform; 107th Congress, April 18, 2002; page 2-3.
204
Id. Page 2.
76
CDC Funding for 3 Epidemics (Estimated)

($ in Millions)
FY 2002 FY 2003
62.1
Diabetes
62.3
932.9
HIV/AIDS
933.2
10.2
Autism
11.7
0 100 200 300 400 500 600 700 800 900 1000
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?” 205
205
http://www.house.gov/reform/burton.02.06.19.ht m
77
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 cale ndar.”206 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. 207 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
206
Letter from Bradely A. Blakeman, The White House to Chairman Dan Burton (January 10, 2003)
207
Reform; 106th Congress; July 18, 2000; pages 3 & 4; Serial No. 106-232 (Opening Statement of Chairman Dan
Burton)
78
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.”208
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.”209 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.”210
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
possib le risk from thimerosal was theoretical, that no proof of harm 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
208
“Mercury in Medicine – Are We Taking Unnecesary Risks?” Hearing Before the Committee on
Government Reform; 106th Congress; July 18, 2000; page 212 ; Serial No. 106-232 (Testimony of Dr. H.
Vasken Aposhian, Professor of Molecular and Cellular Biology, and Pharmacology, University of Arizona)
209
http://www.fda.gov/opacom/hpview.html
210
http://www.fda.gov/oc/opacom/fda101/sld007.html
79
health agencies' failure to act is indicative of institutional malfeasance for self-protection
and misplaced protectionism of the pharmaceutical industry.
80

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Mercury in Medicine

Taking Unnecessary Risks

A Report Prepared by the Staff of the

Chairman Dan Burton

(This Report Is the Result of a Three Year Investigation

I. EXECUTIVE SUMMARY .......................................................................................... 3

II. FINDINGS AND RECOMMENDATIONS ............................................................... 6

VI. A GROWING NUMBER OF SCIENTISTS AND DOCTORS BELIEVE

IX. CONCLUSIONS ......................................................................................................... 78

There's no question that mercury does not belong in vaccines.

II. Findings and Recommendations

1. Mercury is hazardous to humans. Its use in medicinal products is

2. For decades, ethylmercury was used extensively in medical products

3. Manufacturers of vaccines and thimerosal, (an ethylmercury compound

4. Studies and papers documenting the hypoallergenicity and toxicity of

7. A growing number of scientists and researchers believe that a relationship

10. The amount of ethylmercury to which children were exposed through

15. There is inadequate research regarding ethylmercury neurotoxicity and

16. There is inadequate research regarding the relationship between autism

1. Access by independent researchers to the Vaccine Safety Datalink

2. A more integrated approach to mercury research is needed. There are

3. Greater collaboration and cooperation between federal agencies

4. The President should announce a White House conference on autism to

5. Congress needs to pass legislation to include in the National Vaccine

7. Congress should direct the National Institutes of Health to give priority to

A. A Brief Description of Mercury

The nervous system is very sensitive to all forms of mercury.10

B. Thimerosal, Which Contains Ethylmercury, Has Been Used In Medicines Since

Thimerosal was developed by Dr. Morris Kharasch (1895-1957; Ukraine/USA), a

Dr. H. Vasken Aposhian, Professor of Molecular and Cellular Biology and

C. Mercury Is a Known Neurotoxin, But Methylmercury Has Been More Carefully

“The first methylmercury compounds were synthesized in a chemical laboratory

As a result of these emerging concerns, public health officials worldwide began

• Methylmercury is highly toxic.

The medical literature is replete with references to the dangers to methylmercury:

• Severe brain damage

In making a presentation to the Institute of Medicine’s Immunization Safety Review

“More concerning to me in the Institute’s treatment of mercury problems, was the

D. Because of Its Toxicity, Mercury Has Become Heavily Regulated.

1. The EPA Is Regulating the Release of Mercury Into The Environment

2. Different Limits To Exposure To Mercury have Been Established By

In the course of regulating mercury, different government agencies have established

According to the analysis of Dr. McKee, based on the methylmercury ingestion

3. Warnings Have Been Issued About Mercury In Seafood.

Similarly, a March 2001 FDA advisory states:

In addition to the public advisories, the FDA, in January of 2001, established an

“People are exposed every day to a tremendous number of substances in our

The NIH Hatters Pledge:

4. Over the Course of Two Decades, the FDA Slowly Removed

In 1980, the FDA began a lengthy regulatory process to remove ethylmercury

“Over the past several years, because of an increasing awareness of the

E. Thimerosal Is Still Used In Some Medical Products

• Some nasal and ophthalmic products containing thimerosal remain on the

U.S. Military Vaccine Schedule 53

Vaccine # Doses Initial Entry Troops in US Deployed Region or other Thimerosal

DtaP N/A N/A N/A 0 (or 0.5 mcg/dose)

(EPA Safety Limit: 0.1 mcg/kg of body weight per day)

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

IV. There Are Growing Questions About Whether Mercury In Childhood