Executive Summary

In the subsequent five years since the joint US Public Health Service and American Academy of Pediatrics statement of 1999 alerting the public and practitioners to the potential harms of mercury in medicine, specifically Thimerosal (a mercury-laden preservative used in numerous vaccines), there has been a great body of work investigating the link between Thimerosal and neurodevelopmental disorders (NDD) including, and especially, autism.

Within their joint statement, the USPHS and the AAP offered the following:

“…because any potential risk is of concern, the Public Health Service (PHS), the American Academy of Pediatrics (AAP), and vaccine manufacturers agree that thimerosal-containing vaccines should be removed as soon as possible. Similar conclusions were reached this year in a meeting attended by European regulatory agencies, European vaccine manufacturers, and FDA, which examined the use of thimerosal-containing vaccines produced or sold in European countries.”(Thimerosal in Vaccines: A Joint Statement of the American Academy of Pediatrics and the Public Health Service, July 09, 1999)

These matters did not come to the forefront of scientific or public discourse due to any inherent danger by a specific vaccine, but rather the previously overlooked potential cumulative effect of multiple vaccines being given over a short schedule in our nation’s continuing attempt to ward off epidemic and pandemic disease.

In 2001, the Institute of Medicine (IOM) published their first report in what would become a multi-year investigation, including several interim public meetings for the presentations of the most up to date scientific finds. In that report, Immunization Safety Review: Thimerosal - Containing Vaccines and Neurodevelopmental Disorders (2001), the IOM would lay out a well crafted and accepted plan for those necessary scientific efforts to formidably bring answers to the issue. The IOM advised the relevant US government agencies (HHS, PHS, FDA, CDC, NIP) and independent researchers that a combination of epidemiological, animal model, clinical and case studies would be required by the tenets of good science to adequately review and make sound and well-founded determination regarding a possible vaccine-NDD/autism link.

Also in 2001, SafeMinds would learn through Freedom of Information Act (FOIA) requests that the National Immunization Program and Centers for Disease Control and Prevention had already conducted a review within the Vaccine Safety Datalink (VSD) to see if there was any epidemiological link between vaccines and NDDs including autism. That initial effort, led by then CDC research fellow Dr. Thomas Verstraeten, would not be offered to the public or the IOM for review. Verstraeten’s findings showed a strong relationship between enhanced vaccination schedules and numerous symptoms of neurodevelopmental disorders including autism. As will be discussed later, it will not be until a much revised, redacted and watered down version could be accomplished that the CDC would allow the publishing of Verstraeten’s work. While no additional scientific or evidentiary review will be accomplished in the interval between Verstraeten’s initial and final reports, the conclusions would change to reflect a lack of evidence supporting a vaccine-NDD/autism link.

From 2001 through the IOM-Immunization Safety Review Committee’s (ISRC) May 2004 final report and disbanding, it would become apparent that a sole focus upon epidemiological studies in the US and various European countries would be the CDC/NIP’s singular response to the vaccine-NDD/autism hypothesis. Nearly all of these studies, either CDC/NIP sponsored or selected through an exclusive network of conflicted researchers, were found to have been rife with major flaws in methodology and failing to follow acceptable standards in epidemiological practice.

Countering the CDC/NIP response are numerous independent research efforts supported through a mix of academic, private and non-profit foundational, and individual resources. Nearly 100% of non-conflicted research filling the gaps originally called for by the IOM (epidemiology, animal model, clinical, toxicology, case and genomic studies) has shown not only support to the vaccine-NDD/autism hypothesis, but also the elemental furthering in understanding to the biophysical path between exposure and injury.

As early as 1977, Russian researchers began recognizing the potential health hazards from ethyl mercury exposures. Additional studies conducted through the 1980s also documented toxic results from the utilization of thimerosal in various preparations and vaccines.

First afforded in Autism: a novel form of mercury poisoning (2000), Bernard et al laid out the hypothesis of causality between Thimerosal and NDD/autism and the mimicking properties between autism and mercury poisoning. Verstraeten’s original findings proved clearly the epidemiological support to the Thimerosal-NDD/autism, but even those have been buttressed by original and review efforts by others including Blaxill.

Boyd Haley, PhD, professor and chair at the University of Kentucky, Department of Chemistry and H. Vasken Aposhian, Ph.D., Professor, Molecular and Cellular Biology, University of Arizona have both clearly offered to the discussion, and revealed to the IOM/HHS communities, the well founded biological harms seen from ethylmercury (Thimerosal), especially upon the developing fetal/infant/toddler brain. In addition, these researchers have shown the biological variables (age, sex, and synergistic toxicities) that come into play regarding mercury exposure and subsequent injury. Aposhian also went further and offered that the inability for a select population to have an inhibited ability to naturally excrete the heavy metal mercury (as a larger population appears to have the capacity for) is not new to science. In fact, such a syndrome would mimic another well-recognized process called Wilson’s Disease, where a problem excreting the heavy metal copper creates a similar, though not exact, set of circumstances and symptoms.

Issues regarding changes in diagnostics have also been offered as a potential reason for the increases in the autism population’s relationship to increased immunizations. While a few efforts were offered to support that hypothesis, all have subsequently been disproved through review of the data, or independent analysis. The suggested benchmark for such data, California’s Department of Developmental Services, dispels this theory. While admitting minor changes may be inferred by changes in diagnostic criteria, reviewers of the data are comfortable that the exponential increases in autism cannot be supported through minor diagnostic coding changes, and to suggest so is not a defensible position.

In 2003, A Case-Control Study of Mercury Burden in Children with Autistic Spectrum Disorders was published by Jeff Bradstreet, MD, FAAFP, which clinically supported Aposhian’s position of the inability of a select population to efficiently excrete mercury. This research provided that it was possible for a child to have a bioaccumulation of mercury from multiple vaccinations that would lead to eventual neurotoxicity and injury. Bradstreet went forward into a genomic survey of affected and non-affected children, and found specific abnormalities (or single recognized nucleotide polymorphism) found in children with autism spectrum disorders providing actual mapping from exposure to injury.

Dr. Andrew Wakefield and Dr. Jill James joined Bradstreet in presenting these genomic finds in Biological Evidence of Significant Vaccine Related Side-effects Resulting in Neurodevelopmental Disorders.

Further evidence is provided by:

· Richard C. Deth, PhD (Northeastern University, Boston, MA) et al providing scientific understanding of mercury/thimerosal potential influence in pre- and post-natal development

· Burbacher et al, under NIAID/NIH/HHS funding, provided in primate models what had long been disputed: the ability for ethylmercury to cross the blood/brain barrier and be allowed to accumulate to toxic levels. (Requests for HHS to fund necessary further research to qualify the results have gone unanswered.)

· Dr. Mady Hornig (Mailman School of Public Health, Columbia University) et al, looked at the effects of vaccine level thimerosal exposure on mice with a specific genetic susceptibility. Hornig found that the selected mice universally showed an implication of “genetic influences” that led to responses and activities that mimic those found in Autism Spectrum Disorders.

In short, while one side relies singularly and consistently upon proved flawed population-based epidemiology, or sequestered research findings, independent research filling much of the requirements of good science, and the IOM’s stated needs, has amassed an appreciable body of evidence that, at minimum, proves the need for funding appropriate and independent research to follow through until all of the answers are found. In following another tenet of good science, while the independent (non-governmental, government sponsored or otherwise conflicted) have always readily made their efforts and data transparent and open for review. To re-secure the public’s trust in our nation’s immunization program, and affiliated research, every effort should be expended to assure that such openness and transparency is shared by all involved in the discourse.

Introduction

The Coalition for SafeMinds (Sensible Action For Ending Mercury-Induced Neurological Disorders) is a private nonprofit organization founded to investigate and raise awareness of the risks to infants and children of exposure to mercury from medical products, including thimerosal in vaccines. SafeMinds supports research on the potential harmful effects of mercury and thimerosal.

Our mission is to end the health and personal devastations caused by the needless use of mercury in medicines. Utilizing a multifaceted approach, we: (1) work aggressively with government agencies, legislators, manufacturers, and retailers to ensure the removal of mercury from medical and health-related products; (2) press for more research to understand scientifically how mercury in these products causes harm and how effective treatments can be developed for those already exposed; (3) create awareness campaigns to educate parents, clinicians and policy makers about the issue; and (4) encourage open investigations into how mercury has persisted in routine medical products like vaccines despite its known neurotoxicity. To accomplish these goals, we serve actively in the scientific, legal, regulatory, legislative, and public awareness arenas.

SafeMinds believes it is important to acknowledge our belief that vaccines are an integral part of our public health infrastructure, and their importance to that system cannot be understated. That said; we also feel strongly there is an inherent integrity necessary for the continued safety and success of US vaccination efforts. It is to this integrity through safety issue that SafeMinds is looking to support and bolster immunization policies and programs. It will only be through the restoration of the public trust that the successes of past vaccine campaigns can be realized in the future. SafeMinds also firmly believes that parents should be fully informed of the benefits and risks associated with mandatory vaccinations, and that medical, religious, and philosophical exemptions to immunizations should be preserved. States that do not have all three exemptions should review their policies and consider at a minimum to have viable medical and religious exemptions instituted.

A Brief Recap of Autism: A Novel Form of Mercury Poisoning

In 2000, SafeMinds founders presented and published a research effort that aided in propelling this issue into the awareness of the public and government officials. That endeavour, Autism: A Novel Form of Mercury Poisoning[1] (Bernard, Enayati, Redwood, Roger, Binstock) was and remains recognized as a cornerstone document to the discourse on medical mercury exposure and toxicity and its effects on health. In the study, Bernard et al compiled bodies of data, including that of various US government agencies, from several facets of the issue and mapped the path between thimerosal (a widely utilized mercury laden preservative often found in vaccines) and neurological development disorders, including autism.

Autistic spectrum disorder (ASD) is a neurodevelopmental syndrome with onset typically prior to age 36 months. Diagnostic criteria consist of impairments in sociality and communication plus repetitive and stereotypic behaviors and stereotypic behaviors. Traits strongly associated with autism include movement disorders and sensory dysfunctions. Although autism may be apparent soon after birth, most autistic children today experience at least several months, even a year or more of normal development – followed by regression, defined as loss of function or failure to progress.[2]

In the 2000 report, SafeMinds recounted the history of events illuminating the neurotoxicity of mercury (Hg):

¨ Mercury-contaminated fish in Japan - Minimata Disease

¨ Mercury-tainted grain in Iraq, Guatemala and Russia

¨ Acrodynia also called Pink Disease induced by mercury in teething powders

¨ Numerous instances of mercury poisoning through occupational exposures – Mad Hatter’s disease

¨ Numerous animal and in vitro studies providing insights into the mechanisms of mercury toxicity

Based on the admission by the US Food and Drug Administration (FDA) that thimerosal, a product that had been banned as an Over-the-Counter product, was still in use as a vaccine preservative; and that infants were exposed to levels of mercury in excess of federal safety guidelines, SafeMinds looked at the possible consequences to this exposure. The FDA’s announcement coupled with a significant number of parents reporting the onset of symptoms shortly after immunization and the direct correlation in the increased prevalence of ASD and the increased exposure to infants to thimerosal through immunizations, highlighted the need to review the science in both areas to determine if acquired autism was a novel form of mercury poisoning. (Acquired autism is also sometimes called regressive autism. It is this form of autism that has become more prevalent in the last 15 years.)

ASD manifests a constellation of symptoms with much inter-individual variation. A comparison of traits defining, nearly universal to, or commonly found in autism with those known to arise from mercury poisoning which are provided in Table 1 are startlingly similar.

Table 1

Summary Comparison of Traits of Autism and Mercury Poisoning.

Psychiatric Disturbances

Social deficits, shyness, social withdrawal

Repetitive, perseverative, stereotypic behaviors; obsessive-compulsive tendencies

Depression; depressive traits, mood swings, flat affect; impaired face recognition

Anxiety; schizoid tendencies; irrational fears

Irritability, aggression, temper tantrums

Lacks eye contact; impaired visual fixation (Mercury)/problems in joint attention (Autism)

Table 1

Summary Comparison of Traits of Autism and Mercury Poisoning. (continued)

Speech and Language Deficits

Loss of speech, delayed language, failure to develop speech

Dysanthria; articulation; articulation problems

Speech comprehension deficits

Verbalizing and word retrieval problems (mercury); echolalia, word use and pragmatic errors (Autism)

Sensory Abnormalities

Abnormal sensation in mouth and extremities

Sound sensitivity; mild to profound hearing loss

Abnormal touch sensations; touch aversion

Over-sensitivity to light, blurred vision

Motor Disorders

Flapping, myocional jerks, choreiform movements, circling, rocking, toe walking, unusual postures

Deficits in eye-hand coordination; limb apraxia; intention tremors (mercury)/problems with intentional movement or imitation (Autism)

Abnormal gait and posture, clumsiness and in coordination; difficulties sitting, lying, crawling, and walking problem on one side of body.

Cognitive Impairments

Borderline intelligence, mental retardation – some cases reversible

Poor concentration, attention response inhibition (mercury)/ shifting attention (Autism)

Uneven performance on IQ subtests; verbal IQ higher than performance IQ

Poor short term, verbal and auditory memory

Poor visual and perceptual motor skills; impairment in simple reaction time (mercury)/ lower performance on timed tests (Autism)

Deficits in understanding abstract ideas & symbolism; degeneration of higher mental powers (mercury)/sequencing, planning and organizing (autism); difficulty carrying out complex commands

Unusual Behaviors

Self-Injurious behavior e.g. head banging

ADHD traits

Agitation, unprovoked crying, grimacing, staring spells

Sleep difficulties

Physical Disturbances

Hyper-hypotonia; abnormal reflexes; decreased muscle strength, especially upper body; incontinence; problems chewing, swallowing

Rashes, dermatitis, eczema, itching

Diarrhea; abdominal pain/discomfort, constipation, ‘colitis’

Anorexia, nausea (mercury), vomiting (autism); poor appetite (mercury)/ restricted diet (Autism)

Lesions of ileum and colon; increased gut permeability

Table 2

Summary of Comparison of Biological Abnormalities in Autism and Mercury Exposure[3]

Mercury Exposure	Autism
Biochemistry
Binds – SH groups; blocks sulfate transporter in intestines and kidneys.	Low sulfate levels
Reduces glutathione availability; inhibits enzymes of glutathione metabolism; glutathione needed in neurons, cells, and liver to detoxify heavy metals; reduces glutathione peroxidase and reductase.	Low levels of glutathione; decreased ability of liver to detoxify xenobiotics; abnormal glutathione peroxidase activity in erythrocytes.
Disrupts purine and pyrimidine metabolism	Purine and pyromidine metabolism errors lead to autistic features.
Disrupts mitochondrial activities especially in the brain.	Mitochondrial dysfunction, especially in brain.
Immune System
Sensitive individuals more likely to have allergies, asthma, autoimmune-like symptoms, especially rheumatoid-like ones.	More likely to have allergies and asthma; familial presence of autoimmune diseases, especially rheumatoid arthritis; IgA deficiencies
Can produce an immune response in CNS; causes brain/ MBP autoantibodies	On-going immune response in CNS; brain/MBP autoantibodies present
Causes overproduction of TH2 subset; kills/inhibits lymphocytes, T-cells, and monocytes; decreases NK T-cell activity; induces or suppresses IFNg & IL-2	Skewed immune-cell subset in the Th2 direction; decreased responses to T-cell mitogens; reduced NK T-cell function; increased IFNg & IL-12
CNS Structure
Selectively targets brain areas unable to detoxify or reduce mercury-induced oxidative stress	Specific areas of brain pathology; many functions spared
Accumulates in amygdale, hippocampus, basal ganglia, cerebral cortex; damages Purkinje and granule cells in cerebellum; brain stem defects in some cases.	Pathology of amygdale, hippocampus, basal ganglia, cerebral cortex; damage to Purkinje and granule cells in cerebellum; brain stem defects in some cases
Causes abnormal neuronal cytoarchitecture; disrupts neuronal migration, microtubules, and cell division; reduces NCAMs	Neuronal disorganization; increased neuronal cell replication, increased glial cells; depressed expression of NCAMs
Progressive microencephaly.	Progressive microencephaly and macrocephaly

Table 2

Summary of Comparison of Biological Abnormalities in Autism and Mercury Exposure[4] (continued)

Neurochemistry
Prevents presynaptic serotonin release and inhibits serotonin transport; causes calcium disruptions	Decreased serotonin sythesis in children; abnormal calcium metabolism
Alters dopamine systems; peroxidine deficiency in rats resembles mercurialism in humans	Either high or low dopamine levels; positive response to peroxidine, which lowers dopamine levels
Neurochemistry (continued)
Elevates epinephrine and norepinephrine levels by blocking enzyme that degrades epinephrine	Elevated norepinephrine and epinephrine
Elevates glutamate	Elevated glutamate and aspirate
Leads to cortical acetylcholine deficiency; increases muscarinic receptor density in hippocampus and cerebellum	Cortical acetylcholine de