#### 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.)

# I. Executive Summary

Vaccines are the only medicines that American citizens are mandated to
receive as a condition for school and day care attendance, and in some
instances, employment. Additionally, families who receive federal
assistance are also required to show proof that their children have been
fully immunized. While the mandate for which vaccines must be
administered is a state mandate, it is the Federal Government, through
the Centers for Disease Control and Prevention (CDC) and its Advisory
Committee for Immunization Practices that make the Universal
Immunization Recommendations to which the majority of states defer when
determining mandates. Since the early to mid-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, Thimerosal[^2], 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]

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.

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 mercury amalgams are available
for use. This concern remains under investigation by the Subcommittee on
Human Rights and Wellness.

# 

# 

# II. Findings and Recommendations

## 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.

8.  The FDA acted too slowly to remove ethylmercury from
    over-the-counter products like topical ointments and skin creams.
    Although an advisory committee determined that ethylmercury was
    unsafe in these products in 1980, a rule requiring its removal was
    not finalized until 1998.

9.  The FDA and the CDC failed in their duty to be vigilant as new
    vaccines containing thimerosal were approved and added to the
    immunization schedule. When the Hepatitis B and Haemophilus
    Influenzae Type b vaccines were added to the recommended schedule of
    childhood immunizations, the cumulative amount of ethylmercury to
    which children were exposed nearly tripled.

10. The amount of ethylmercury to which children were exposed through
    vaccines prior to the 1999 announcement exceeded two safety
    thresholds established by the Federal government for a closely
    related substance -- methylmercury. While the Federal Government has
    established no safety threshold for ethylmercury, experts agree that
    the methylmercury guidelines are a good substitute. Federal health
    officials have conceded that the amount of thimerosal in vaccines
    exceeded the EPA threshold of 0.1 micrograms per kilogram of
    bodyweight. In fact, the amount of mercury in one dose of DTaP or
    Hepatitis B vaccines (25 micrograms each) exceeded this threshold
    many times over. Federal health officials have not conceded that
    this amount of thimerosal in vaccines exceeded the FDA's more
    relaxed threshold of 0.4 micrograms per kilogram of body weight. In
    most cases, however, it clearly did.

11. The actions taken by the HHS to remove thimerosal from vaccines in
    1999 were not sufficiently aggressive. As a result, thimerosal
    remained in some vaccines for an additional two years.

12. The CDC's failure to state a preference for thimerosal-free vaccines
    in 2000 and again in 2001 was an abdication of their responsibility.
    As a result, many children received vaccines containing thimerosal
    when thimerosal-free alternatives were available.

13. The Influenza vaccine appears to be the sole remaining vaccine given
    to children in the United States on a regular basis that contains
    thimerosal. Two formulations recommended for children six months of
    age or older continue to contain trace amounts of thimerosal.
    Thimerosal should be removed from these vaccines. No amount of
    mercury is appropriate in any childhood vaccine.

14. The CDC in general and the National Immunization Program in
    particular are conflicted in their duties to monitor the safety of
    vaccines, while also charged with the responsibility of purchasing
    vaccines for resale as well as promoting increased immunization
    rates.

15. There is inadequate research regarding ethylmercury neurotoxicity
    and nephrotoxicity.

16. There is inadequate research regarding the relationship between
    autism and the use of mercury-containing vaccines.

17. To date, studies conducted or funded by the CDC that purportedly
    dispute any correlation between autism and vaccine injury have been
    of poor design, under-powered, and fatally flawed. The CDC's rush to
    support and promote such research is reflective of a philosophical
    conflict in looking fairly at emerging theories and clinical data
    related to adverse reactions from vaccinations.

## B. Recommendations

1.  Access by independent researchers to the Vaccine Safety Datalink
    database is needed for independent replication and validation of CDC
    studies regarding exposure of infants to mercury-containing vaccines
    and autism. The current process to allow access remains inadequate.

2.  A more integrated approach to mercury research is needed. There are
    different routes that mercury takes into the body, and there are
    different rates of absorption. Mercury bioaccumulates; the Agency
    for Toxic Substances and Disease Registry (ATSDR) clearly states:
    "*This substance may harm you."*[^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 statute of limitations as recommended by
    the Advisory Commission on Childhood Vaccines from 3 to 6 years.
    Second, establishing a one to two-year window for families, whose
    children were injured after 1988 but who do not fit within the
    statute of limitations, to have the opportunity to file under the
    NVICP.

6.  Congress should enact legislation that prohibits federal funds from
    being used to provide products or pharmaceuticals that contain
    mercury, methylmercury, or ethylmercury unless no reasonable
    alternative is available.

7.  Congress should direct the National Institutes of Health to give
    priority to research projects studying causal relationships between
    exposure to mercury, methylmercury, and ethylmercury to autism
    spectrum disorders, attention deficit disorders, Gulf War Syndrome,
    and Alzheimer's Disease.

[^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; 106^th^ Congress; July
    18, 2000; pages 3 & 4; Serial No. 106-232 (Opening Statement of
    Chairman Dan Burton)

[^4]: "Mercury in Medicine -- Are We Taking Unnecesary Risks?" Hearing
    Before the Committee on Government Reform; 106^th^ 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](http://www.fda.gov/oc/opacom/fda101/fda101text.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>

[^7]: The FDA defines "trace amounts" of ethylmercury as less than 1
    microgram.

[^8]: Agency for Toxic Substances and Disease Registry (ASTDR), [Public
    Health Statement for Mercury]{.underline}, CAS# 7439-97-6, March
    1999.