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Which Vaccines Still Contain Mercury?
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Autism and Mercury   •   Testimony Before Congress by Stephanie Cave, M.D.
 

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Dr. Stephanie Cave, MD

Autism and Mercury
(Thimerosal in Children's Vaccines)

Testimony Presented By Stephanie Cave, M.D.
Before the Committee on Government Reform
U.S. House of Representatives
July 18, 2000

[ scroll down for many additional documents, articles and and recent research studies ]

"My name is Stephanie Cave. I am in family practice in Baton Rouge, Louisiana. I want to express my deep appreciation to you, Mr. Burton, and to the members of your committee for allowing me to testify today.

I am presently treating over 300 autistic children with an additional 150 waiting to get in as soon as we can accommodate them. Dr. Amy Holmes, the physician-parent of an autistic child, joined me in February to help with the overwhelming numbers of children with this problem. We are treating children from all over the United States and getting calls from many places around the globe. This is truly an epidemic.

Autism was first described in 1943 by Kanner. Thimerosal, a mercury containing preservative, was first used in the vaccines in the early 1930s. Prior to 1970 the prevalence of autism was 1 in 2000. In 1970 it was 1 in 1000 and in 1996 the NIH estimated it to be 1 in 500. In the year 2000 reports from the education sector revealed the incidence to be 1 in 150.

Mercury can exist as a pure element or in various forms of inorganic and organic mercury. It affects the immune system and neurological systems at a very basic level. The timing of infant and toddler vaccines, with mercury, corresponds to critical periods of neuronal development. The blood brain barrier is not fully developed in the infant or toddler. The fetus is at risk of exposure to toxins during gestation including methyl mercury from seafood eaten by the mother. Other sources of heavy metals are amalgam fillings in the mother, Rhogam which is usually given to Rh negative mothers around 28 weeks gestation, and the influenza vaccine given during pregnancy.

These metals can be passed not only transplacentally, but also through breast milk to the infant at a time when the liver detoxification process in not perfected to the point of removing the metals. We have measured this detoxification process and have found it to be woefully inadequate in the developmentally delayed children. The organic ethyl mercury, injected in bolus through vaccines, enters the brain and converts to inorganic mercury, which cannot cross back over the blood brain barrier. This form is more likely to cause autoimmune antibodies to brain tissue. Similar antibodies appear in autism.

I believe that the introduction of the hepatitis B vaccine in 1991 has sparked this recent epidemic because of the thimerosal. When added to the mercury imparted through the DTP and HIB the exposure to mercury exceeds the EPA safe limits for the metal considering a bolus dose on a single day. The EPA safe limits are usually related to ingested mercury, which is partially cleared by the liver. Injecting boluses of ethyl mercury presents another scenario. The two- month dose of mercury is at least 30 times higher than the recommended daily maximum exposure as set by the EPA.

During the 1990s infants received 12.5 mcg of mercury at birth followed by 12.5 mcg at one month, 50 mcg at 2 months, 50 mcg at 4 months, 62.5 mcg at 6 months, 50 mcg at 15 to 18 months. The total of 237.5 mcg for a child, who at best weighs 10 kg, far exceeds the safety limits if you consider bolus doses. In establishing normal safety levels, if there is indeed such a thing for a metal as toxic as mercury, bolus injections were not considered. If the nurse giving the injection did not shake the vial according to directions before drawing out the vaccine dose, there is a chance that the child receiving the last dose could get as much as 10 times the usual amount in one dose.

Stajeck and Lopez (Journal of Pediatrics, 2000) have shown mercury in the blood of infants at birth prior to the hepatitis B injections. After the vaccine, the levels rose in the blood of the infants tested. In some preterm infants there were levels that measured ten times that seen in term infants. The bile production is minimal in infants, 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 can increase the permeability of the gastrointestinal tract and blood brain barrier. Mercury affects precisely those parts of the brain affected in autismăthe cerebellum amygdala, and frontal cortex accounting for the myriad of symptoms in mercury poisoning and autism. When displayed, these symptoms superimpose on each other. The following are prevalent in both: social withdrawal, depression, lack of eye contact, delayed speech, increased sound and touch sensitivity, tremors, seizures, poor concentration, poor memory, repetitive behaviors, sleeping problems, self-injurious behaviors, rashes, anorexia, accelerated cell death in the central nervous system, and prevalence of autoimmune disorders.

The injection of mercury appears to affect only certain children, but I fear that we have underestimated the devastation by concentrating on the autistic children. We are measuring elevated levels of mercury in other children with milder difficulties like learning disabilities, ADHD, and Asperger's Syndrome. We do not have any idea what the scope of this problem is at this point. There are no safety standards for infants getting bolus doses of ethyl mercury. We cannot compare the effects of a bolus dose in an infant to a daily dose in an adult. There are no parameters for comparison.

We have simplified the problem in our practice. We test all developmentally delayed children for the presence of heavy metals. Hair is screened followed by a determination in urine after a challenge of an oral chelator, DMSA (2,3 Dimercaptosuccinic). It is rare that we find any child with a developmental problem who does not have increased levels of mercury in the urine after a chelator challenge. An interesting phenomenon is that we are finding many more lead intoxicated children than blood screen would indicate. Lead amplifies the toxicity of ethyl mercury in the brain.

We perform a number of tests on blood, urine, hair and stool in the autistic children. The abnormal findings that we see in autism involving the immune system, GI tract, and central nervous system are also seen in mercury poisoning. These include, but are not limited to changes in T lymphocytes, low levels of glutathione, low sulfate levels, IgA deficiency, and the presence of myelin basic protein antibodies in brain. The children are responding well to the use of oral chelators and supplements, which take out heavy metals. We are measuring levels in urine as we treat. The changes in the children are remarkable with each dose of a chelator. This treatment may take months to complete, but the chance for recovery is evident on a daily basis. Because mercury has such far-reaching effects in the destruction of function in many systems of the body, our treatment also involves nutritional repletion of cellular chemistry, normalization of gastrointestinal bacterial balance, dietary programs, and restoration of liver detoxification systems.

Our medical training did not adequately prepare us for this challenge. We learned little about testing for heavy metals and even less about treating. The word chelation is not in the vocabulary of most physicians. The few physicians who are treating these children are inundated with them in their practices. The good news is that they are responding well to the chelation treatment. The changes in neurological functioning are remarkable with each day of treatment.

It is imperative that we stop giving heavy metals to children through vaccines when their bodies can least handle such an insult. We are seeking the link on a daily basis. The children are recovering steadily, but the treatment is expensive and tedious.

It would make more sense for us to eliminate the cause of the problem by deleting thimerosal from the vaccines now and by withdrawing current lots containing thimerosal from the pediatric offices and health units. We also need to channel funds for research into the clinical trials needed to explore the link between mercury and developmental problems in children."

 

REFERENCES

 

  1. Bernard, S., Enayati, A., Roger, H., Redwood, L., Binstock, T. Autism: A Unique Type of Mercury Poisoning. Condensed draft of June 27, 2000.
  2. Kanner, L., Autistic Disturbances of Affective Contact. The Nervous Child 1942-1943;2: 217-250.
  3. CDC. Thimerosal in Vaccines: a Joint Statement of the American Academy of Pediatrics and the Public Health Service. MMRW 1999;48. 26:563-565.
  4. CDC. Recommendations Regarding the Use of Vaccines That Contain Thimerosal as a Preservative. MMWR, 1999; 48. 43. 996-998.
  5. Correspondence from Theresa Binstock to David Satcher, MD, PhD. July 5, 2000.
  6. Edelson, S.B. Mercury: The Basis Cause of Major Chronic Diseases of the New Millenium, 2000.
  7. Stajeck, G.V., Lopez, G.P., Sokei, H., Sexson, W. Iatrogenic Exposure to Mercury After Hepatitis B Vaccination in Preterm Infants. Journal of Pediatrics, Vol 136, Number 5, May 2000, pp679-681.
  8. Steuerwald, U., Wibe, P., Jorgensen, P., Bjerve, K., Brock, J., Heinzow, B., Jorgenson, E., Grandjean, P., Maternal Seafood Diet, Methylmercury Exposure, and Neonatal Neurologic Function. The Journal of Pediatrics. Vol 136, Number 5, May, 2000, pp 599-605.
  9. Haley, Boyd presentation The toxic effects of oral mercury, Mercury Toxicity Workshop, Dallas, Texas, May 4, 2000.
  10. Aschner, Michael. Environmental mercury toxicity presentation, Mercury Toxicity Workshop, Dallas, Texas, May 4, 2000.
  11. Case Studies in Environmental Medicine: Mercury Toxicity, March 1992, U.S. Department of Health and Human Services.
 U.S. Department of Health and Human Services

 Testimony, Autism and Mercury, before Congress


Additional Reading: Articles, Interviews, Research Studies and Other Publications Relevant to Dr. Stephanie Cave


WHAT ARE THE VACCINES THAT STILL CONTAIN THIMEROSAL?

The tables below are from the U.S. Food and Drug Administration (FDA) | Center for Biologics Evaluation and Research (CBER) Page: Thimerosal in Vaccines as of July 4, 2008.

These three tables of vaccines, showing the amount of thimerosal in vaccines, are taken from the following sections of the FDA/CBER website page referenced above:

  1. Table 1. Thimerosal Content of Vaccines Routinely Recommended for Children 6 Years of Age and Younger
  2. Table 2: Preservatives Used in U.S. Licensed Vaccines
  3. Table 3: Thimerosal and Expanded List of Vaccines - Thimerosal Content in Currently Manufactured U.S. Licensed Vaccines

Tables

Table 1. Thimerosal Content of Vaccines Routinely Recommended for Children 6 Years of Age and Younger - (updated 7/18/2005*)
*Since this update, a biologics license application was approved for Rotavirus Vaccine, Tradename-RotaTeq (Merck), that is thimerosal free and never contained thimerosal.

Vaccine Tradename
(Manufacturer)
Thimerosal Status Concentration**(Mercury) Approval Date for Thimerosal Free or Thimerosal / Preservative Free (Trace Thimerosal)*** Formulation
DTaP Infanrix
(GlaxoSmithKline Biologicals)
Free Never contained more than a trace of thimerosal, approval date for thimerosal-free formulation 9/29/2000
Daptacel
(Sanofi Pasteur, Ltd)
Free Never contained Thimerosal
Tripedia
(Sanofi Pasteur, Inc)
Trace(≤0.3 µg Hg/0.5mL dose) 03/07/01
DTaP-HepB-IPV Pediarix
(GlaxoSmithKline Biologicals)
Free Never contained more than a Trace of Thimerosal, approval date for thimerosal-free formulation 1/29/2007
Pneumococcal conjugate Prevnar
(Wyeth Pharmaceuticals Inc)
Free Never contained Thimerosal
Inactivated Poliovirus IPOL
(Sanofi Pasteur, SA)
Free Never contained Thimerosal
Varicella (chicken pox) Varivax
(Merck & Co, Inc)
Free Never contained Thimerosal
Mumps, measles, and rubella M-M-R-II
(Merck & Co, Inc)
Free Never contained Thimerosal
Hepatitis B Recombivax HB
(Merck & Co, Inc)
Free 08/27/99
Engerix B
(GlaxoSmithKline Biologicals)
Free 03/28/00, approval date for thimerosal-free formulation 1/30/2007
Haemophilus influenzae type b conjugate (Hib) ActHIB
(Sanofi Pasteur, SA)
OmniHIB
(GlaxoSmithKline)
Free Never contained Thimerosal
PedvaxHIB
(Merck & Co, Inc)
Free 08/99
HibTITER, single dose
(Wyeth Pharmaceuticals, Inc.)1
Free Never contained Thimerosal
Hib/Hepatitis B combination Comvax
(Merck & Co, Inc)
Free Never contained Thimerosal
Influenza Fluzone
(Sanofi Pasteur, Inc)
0.01% (12.5 µg/0.25 mL dose, 25 µg/0.5 mL dose)2  
Fluzone
(Sanofi Pasteur, Inc)3
(no thimerosal)
Free 12/23/2004
Fluvirin
(Novartis Vaccines and Diagnostics Ltd)
0.01% (25 µg/0.5 mL dose)  
Fluvirin
(Novartis Vaccines and Diagnostics Ltd)
(Preservative Free)
Trace (<1 µg hg/0.5ml dose) 09/28/01
Influenza, live FluMist
(MedImmune Vaccines, Inc)
Free Never contained Thimerosal

** Thimerosal is approximately 50% mercury (Hg) by weight. A 0.01% solution (1 part per 10,000) of thimerosal contains 50 µg of Hg per 1 mL dose or 25 µg of Hg per 0.5 mL dose.
*** The term "trace" has been taken in this context to mean 1 microgram of mercury per dose or less.
1 HibTiITER was also manufactured in thimerosal-preservative containing multidose vials but these were no longer available after 2002.
2 Children 6 months old to less than 3 years of age receive a half-dose of vaccine, i.e., 0.25 mL; children 3 years of age and older receive 0.5 mL.
3 A trace thimerosal containing formulation of Fluzone was approved on 9/14/02 and has been replaced with the formulation without thimerosal.


Table 2: Preservatives Used in U.S. Licensed Vaccines

Preservative Vaccine Examples (Tradename; Manufacturer)
Thimerosal TT (one)
Influenza (several)
Phenol Typhoid Vi Polysaccharide (Typhim Vi; Sanofi Pasteur, SA)
Pneumococcal Polysaccharide (Pneumovax 23; Merck & Co, Inc)
Benzethonium chloride (Phemerol) Anthrax (Biothrax; BioPort Corporation)
2-phenoxyethanol DTaP (Infanrix; GlaxoSmithKline Biologicals)
DTaP (Daptacel; Sanofi Pasteur, Ltd)
Hepatitis A/Hepatitis B (Twinrix; GlaxoSmithKline Biologicals)
IPV (IPOL; Sanofi Pasteur, SA)


Table 3: Thimerosal and Expanded List of Vaccines - (updated 3/14/2008)
Thimerosal Content in Currently Manufactured U.S. Licensed Vaccines

Vaccine Trade Name Manufacturer Thimerosal Concentration1 Mercury
Anthrax Anthrax vaccine BioPort Corporation 0 0
DTaP Tripedia2 Sanofi Pasteur, Inc ≤ 0.00012% ≤ 0.3 µg/0.5 mL dose
Infanrix GlaxoSmithKline Biologicals 0 0
Daptacel Sanofi Pasteur, Ltd 0 0
DTaP-HepB-IPV Pediarix GlaxoSmithKline Biologicals 0 0
DT No Trade Name Sanofi Pasteur, Inc < 0.00012% (single dose) < 0.3 µg/0.5ml dose
Sanofi Pasteur, Ltd3 0.01% 25 µg/0.5 mL dose
Td No Trade Name Mass Public Health 0.0033% 8.3 µg/0.5 mL dose
Decavac Sanofi Pasteur, Inc ≤ 0.00012% ≤ 0.3 µg mercury/0.5 ml dose
No Trade Name Sanofi Pasteur, Ltd 0 0
Tdap Adacel Sanofi Pasteur, Ltd 0 0
Boostrix GlaxoSmithKline Biologicals 0 0
TT No Trade Name Sanofi Pasteur, Inc 0.01% 25 µg/0.5 mL dose
Hib ActHIB/OmniHIB4 Sanofi Pasteur, SA 0 0
HibTITER Wyeth Pharmaceuticals, Inc. 0 0
PedvaxHIB liquid Merck & Co, Inc 0 0
Hib/HepB COMVAX5 Merck & Co, Inc 0 0
Hepatitis B Engerix-B
Pediatric/adolescent

Adult

GlaxoSmithKline Biologicals    

0

0

 

0

0

Recombivax HB

Pediatric/adolescent

Adult (adolescent)

Dialysis

Merck & Co, Inc  

0

0

0

 

0

0

0

Hepatitis A Havrix GlaxoSmithKline Biologicals 0 0
Vaqta Merck & Co, Inc 0 0
HepA/HepB Twinrix GlaxoSmithKline Biologicals < 0.0002% < 1 µg/1ml dose
IPV IPOL Sanofi Pasteur, SA 0 0
Poliovax Sanofi Pasteur, Ltd 0 0
Influenza Afluria CSL Limited 0 (single dose)
0.01% (multidose)
0/0.5 mL (single dose)
24.5 µg/0.5 mL (multidose)
Fluzone6 Sanofi Pasteur, Inc 0.01% 25 µg/0.5 mL dose
Fluvirin Novartis Vaccines and Diagnostics Ltd 0.01% 25 µg/0.5 ml dose
Fluzone (no thimerosal) Sanofi Pasteur, Inc 0 0
Fluvirin (Preservative Free) Novartis Vaccines and Diagnostics Ltd < 0.0004% < 1 µg/0.5 ml dose
Fluarix GlaxoSmithKline Biologicals < 0.0004% < 1 µg/0.5 ml dose
FluLaval ID Biomedical Corporation of Quebec 0.01% 25 µg/0.5 ml dose
Influenza, live FluMist MedImmune Vaccines, Inc 0 0
Japanese Encephalitis7 JE-VAX Research Foundation for Microbial Diseases of Osaka University 0.007% 35 µg/1.0mL dose
17.5 µg/0.5 mL dose
MMR MMR-II Merck & Co, Inc 0 0
Meningococcal Menomune A, C, AC and A/C/Y/W-135 Sanofi Pasteur, Inc 0.01% (multidose)
0 (single dose)
25 µg/0.5 dose
0
Menactra A, C, Y and W-135 Sanofi Pasteur, Inc 0 0
Pneumococcal Prevnar (Pneumo Conjugate) Wyeth Pharmaceuticals Inc 0 0
Pneumovax 23 Merck & Co, Inc 0 0
Rabies IMOVAX Sanofi Pasteur, SA 0 0
Rabavert Novartis Vaccines and Diagnostics 0 0
Smallpox (Vaccinia), Live ACAM2000 Acambis, Inc. 0 0
Typhoid Fever Typhim Vi Sanofi Pasteur, SA 0 0
Vivotif Berna Biotech, Ltd 0 0
Varicella Varivax Merck & Co, Inc 0 0
Yellow Fever Y-F-Vax Sanofi Pasteur, Inc 0 0
Table Footnotes
  1. Thimerosal is approximately 50% mercury (Hg) by weight. A 0.01% solution (1 part per 10,000) of thimerosal contains 50 µg of Hg per 1 ml dose or 25 µg of Hg per 0.5 ml dose.
  2. Sanofi Pasteur's Tripedia may be used to reconstitute ActHib to form TriHIBit. TriHIBit is indicated for use in children 15 to 18 months of age.
  3. This vaccine is not marketed in the US.
  4. OmniHIB is manufactured by Sanofi Pasteur but distributed by GlaxoSmithKline.
  5. COMVAX is not licensed for use under 6 weeks of age because of decreased response to the Hib component.
  6. Children under 3 years of age receive a half-dose of vaccine, i.e., 0.25 mL (12.5 µg mercury/dose.)
  7. JE-VAX is distributed by Aventis Pasteur. Children 1 to 3 years of age receive a half-dose of vaccine, i.e., 0.5 mL (17.5 µg mercury/dose).

[ Return to Index of Articles on Thimerosal in Vaccines | Autism and Mercury Link ]


The Book, What Your Doctor May Not Tell You About Children's Vaccines, by Stephanie Cave, M.D.

What Your Doctor May Not Tell You About Children's Vaccines, by Dr. Stephanie Cave, M.D. In this book, Dr. Stephanie Cave explains vaccinations—the pros and the cons. With detailed facts about each vaccination, as well as regulations and laws, this book provides easily understandable information to help parents make a knowledgeable, responsible choice about vaccinating their children. Stephanie Cave, M.D., is a family practitioner in Baton Rouge who specializes in children with autism and related disorders. She has been featured on CNN regarding children and vaccinations and testified in congressional hearings in July 2000.

We may be overvaccinating our children today, once considered a godsend, vaccines are felt by some to be associated with dramatic increases in brain and autoimmune diseases such as autism, asthma, learning disabilities and ADHD. This book is a vital down to earth guide that will tell you which vaccines may be risky and what to consider to safely vaccinate your children. Written by an expert on pediatric vaccinations, this book arms you with:

  • Guidance on when to give children vaccinations—and which ones to give
  • Details on vaccines for Hepatitis A and B, DTP, Hib, Polio, MMR, Chicken Pox, Pneumococcus and many others
  • Research and safety track records for various shots
  • Precautions Parents can take when their children get vaccinated, including vitamins and natural supplements

"Excellent...a must read. If you are a parent, or soon-to-be parent, read this book. If you are concerned about the horrific and unexplained rise in autism, ADHD, childhood diabetes, asthma, allergies and a host of other disorders, read this book.

— Bernard, Rimland, Pd.D., founder, Autism Society of America, and director, Autism Research Institute

Review from Amazon.com

"As a pediatrician treating autistic children, some of whom have high levels of metal in their systems, Stephanie Cave, in my opinion, is the expert I most trust. Her book is balanced, and I loved that she layed out an alternative vaccine schedule. I have read several other vaccine books on both ends of the spectrum, and this one is the most sensible, balanced, comprehensive and sane, right down the middle. She recognizes the value of certain vaccines, yet also acknowledges risks and concerns about the CDC's agressive vaccine schedule for infants."
Table of Contents
Introduction
Part I   Introducing Vaccines
  Chapter 1   The Story of Vaccines
  Chapter 2   How Safe Are Vaccines?
  Chapter 3   Mercury in Vaccines: Shots of Danger?
  Chapter 4   The Autism Debate
  Chapter 5   When the Body Attacks Itself: Autoimmune Disorders
Part II   The Vaccines
  Chapter 6   Hepatitis B Vaccine
  Chapter 7   DTP/DTaP: Diptheria, Tetanus, Pertussis
  Chapter 8   Hib: Haemophilus Influenzae Type B Vaccine
  Chapter 9   Polio
  Chapter 10   MMR: Measles, Mumps, Rubella
  Chapter 11   Varicella (Chicken Pox)
  Chapter 12   Other Vaccines

By ordering What Your Doctor May Not Tell You About Children's Vaccines, by Stephanie Cave, M.D. directly from this link to Amazon.com
You will be helping to support The Healing Center's libraries of online articles and other outreach projects, including and especially this
Website on Innovative and Alternative Treatments for Children with Developmental Disorders and Related Neurometabolic Conditions.

[ Return to Index of Articles on Thimerosal in Vaccines | Autism and Mercury Link ]


Footnotes:
  1. HR 5710, the Homeland Security Act of 2002 and Immunity for Vaccine Manufacturer Eli Lilly Regarding Its Use of Thimerosal  Mercury Autism Research Study 160 KB

    Excerpts: HR 5710, the Homeland Security Act of 2002 passed the House on November 13. Several provisions, not germane to the Legislation were inserted without the knowledge of some who voted to approve this Bill - and without discussion or debate. Given the contentious nature and the broad reaching effects of these provisions, it would be prudent to remove Sections 1714, 1715, 1716 and 1717 from the Senate Bill. These issues, all public health related, should be taken up for full discussion, debate and public input in the new 108th Congress.

    According to media reports, these provisions were inserted by retiring Representative Richard Armey (R-TX) at the request of the [President George W. Bush] White House. Section 1714-1717 affect the National Vaccine Injury Compensation Act do not protect Americans from a terrorist threat, or affect the Department of Homeland Security, rather they protect large domestic chemical companies from potential civil liability to hundreds of thousands of vaccine injured children in the United States. Amending the Vaccine Act through this legislation is inappropriate. If the desire is to protect manufacturers of the components of any smallpox vaccine, the date of enactment should not suspend any currently filed cases which are not related to smallpox but to thimerosal.

    The compensation program was created through an excise tax from the sale of vaccines, the chemical companies who manufacture components of vaccines such as thimerosal do not contribute to this fund. In fact, they are being offered a free ride, no liability, no discussion and debate, no opportunity for the public or the Special Masters who hear these cases to weigh in.

    Sections 1714-1717 will have a devastating effect on the families of children who were injured from their thimerosal-containing vaccines and suffered damage to their central nervous system, resulting in diagnosis of autism spectrum disorder, speech and language delays, or neurodevelopmental delays.

    Section 1714 offers protection for the manufacturers of all ingredients of vaccines rather than simply the vaccine manufacturers from litigation from individuals who have not yet gone through the National Vaccine Injury Compensation Program [see also the Database of Vaccine Injury: The Vaccine Adverse Event Reporting System (VAERS)). Eli Lilly and other companies that are co-defenders in ongoing thimerosal-related litigation (and who have made no financial contribution to the vaccine trust fund) will be indemnified from all vaccine ingredient lawsuits. It is clear that by including a retroactive date of effective date while not including an extension of the statute of limitation, that the intent was to stop all ongoing litigation that has not yet gone to judgement that this action was taken to protect these companies.

    Table of Contents:

    [ Return to Text ]

  2. Advisory Committee on Immunization Practices (ACIP)

    The Advisory Committee on Immunization Practices (ACIP) consists of 15 experts in fields associated with immunization who have been selected by the Secretary of the U. S. Department of Health and Human Services to provide advice and guidance to the Secretary, the Assistant Secretary for Health, and the Centers for Disease Control and Prevention (CDC) on the control of vaccine-preventable diseases.

    The Committee develops written recommendations for the routine administration of vaccines to children and adults in the civilian population; recommendations include age for vaccine administration number of doses and dosing interval, and precautions and contraindications. The ACIP is the only entity in the federal government that makes such recommendations.

    The overall goals of the ACIP are to provide advice that will lead to a reduction in the incidence of vaccine preventable diseases in the United States, and an increase in the safe use of vaccines and related biological products.

    On May 28, 2004 ACIP recommended that children between the ages of 6 and 23 months routinely receive an inactivated influenza (flu) vaccine. ACIP does not recommend using the thimerosal-free flu vaccine over the thimerosal-containing flu vaccine, and states that the benefits of flu vaccination outweigh any risk from thimerosal exposure. [ Return to Text ]

  3. See also: Thimerosal and Autism? A Plausible Hypothesis That Should Not Be Dismissed Mercury Autism Research Study 176 KB
    Mark F. Blaxill, Lyn Redwood and Sallie Bernard; Medical Hypotheses; Volume 62, Issue 5, May 2004, Pages 788-794

    Abstract: The autism-mercury hypothesis first described by Bernard et al. has generated much interest and controversy. The Institute of Medicine (IOM) reviewed the connection between mercury-containing vaccines and neurodevelopmental disorders, including autism. They concluded that the hypothesis was biologically plausible but that there was insufficient evidence to accept or reject a causal connection and recommended a comprehensive research program. Without citing new experimental evidence, a number of observers have offered opinions on the subject, some of which reject the IOM's conclusions. In a recent review, Nelson and Bauman argue that a link between the preservative thimerosal, the source of the mercury in childhood vaccines, is improbable. In their defense of thimerosal, these authors take a narrow view of the original hypothesis, provide no new evidence, and rely on selective citations and flawed reasoning. We provide evidence here to refute the Nelson and Bauman critique and to defend the autism-mercury hypothesis.

    Excerpt: Nelson and Bauman also cite two well-known studies in the mercury literature, the Faroe and Seychelles Islands investigations [37,38], which examined long-term, neurodevelopmental outcomes in two populations exposed to dietary methylmercury. They cite the absence of autism cases reported in these two studies while observing that these studies "were probably large enough to detect a substantial but not minor increase in autism, if it was present", in the exposed populations. This argument fails for several reasons. First, both studies were conducted on very small populations of children, well under one thousand, neither of which could be expected to yield a significant number of children with autism at historic prevalence rates (more relevant to dietary exposures) and would yield only 2-3 autistic children at more recent prevalence levels (which would only prevail under the recent, elevated exposure conditions).

    Second, children with neurological disease, particularly those with seizure disorders (which can affect as many as one-third of children with autism), were excluded from the Faeroe investigations.

    Third, neither of these populations were exposed to thimerosal in vaccines at the levels of recent concern: the Seychelles are a developing nation and the Faeroes, under Danish control, operated under childhood immunization schedules that kept thimerosal exposures low (Grandjean, personal communication). Therefore, the fact that autism was not cited in either of these studies provides little reassurance of any kind, contrary to the authors' suggestions.

    Finally, Nelson and Bauman run through a familiar litany of arguments designed to obscure the strong evidence of increasing incidence of autism, including: diagnostic substitution [39], lower diagnostic standards, and methodological non-comparability [40]. Although many have offered speculative theories [41] with an eye to dismissing the mounting evidence of increasing incidence of autism, none of these hypotheses have been effectively tested and replicated. To the extent that they can be quickly tested, several recent authors have either falsified the hypothesis of diagnostic substitution and lower diagnostic standards [39,42-45] or failed to find any evidence in favor of them [46,47]. [ Return to Text ]

  4. Report from the Division of Vaccine Injury Compensation (DVIC): National Vaccine Injury Compensation Program: Advisory Commission on Childhood Vaccines Meeting (Conference Call), June 7, 2007

    Although the Hannah Poling case may have been deemed by David Kirby (author of the book, Evidence of Harm: Mercury in Vaccines and the Autism Epidemic: A Medical Controversy) an "unprecedented concession", in reviewing the minutes of a conference call meeting—the 66th quarterly meeting of the Advisory Commission of Childhood Vaccines (ACCV)—excerpted below, the amount of "awards" granted by the National Vaccine Injury Compensation Program (VICP) appears to be staggering (although perhaps these "awards" were not obtained through any judicial hearing, and are thus not generally in the public's knowledge):

    Statistical Report: "Dr. Evans [Geoffrey Evans, M.D., Director, Division of Vaccine Injury Compensation (DVIC)] stated that the number of autism claims filed continued to decline. As of April 30, only 70 had been filed this fiscal year (FY). The number of non-autism claims filed is 109, and will probably increase because of the upcoming 2-year deadline on July 1 for influenza vaccines that ends the 8-year retroactive coverage filing period whenever a new vaccine is added to the Vaccine Injury Table Mercury Autism Research Study 44 KB. Annual awards have been fairly consistent for the past several years, averaging around $58 million for petitioners and $4 million for legal fees. The FY 2007 awards are down slightly at $43.6 million to date [6/7/2007]. The Vaccine Injury Compensation Trust Fund balance is $2.5 billion and increasing at a higher rate than before because of the addition of influenza vaccine. About $300 million will be added in 2007, one-third of which derives from interest on the principal."

    Awards: "On April 24, the largest single award since the inception of the National Vaccine Injury Compensation Program (VICP) was made, a $10 million award consisting of three annuity contracts and four lump sums. It was awarded to Mario Arturo Rodriguez for a measles, mumps, and rubella vaccine-related injury. This case received national media attention."

    About the National Vaccine Injury Compensation Program (VICP): On October 1, 1988, the National Childhood Vaccine Injury Act of 1986 (Public Law 99-660) Mercury Autism Research Study 8 KB created the National Vaccine Injury Compensation Program (VICP). The VICP was established to ensure an adequate supply of vaccines, stabilize vaccine costs, and establish and maintain an accessible and efficient forum for individuals found to be injured by certain vaccines. The VICP is a no-fault alternative to the traditional tort system for resolving vaccine injury claims that provides compensation to people found to be injured by certain vaccines. The U. S. Court of Federal Claims decides who will be paid. Three Federal government offices have a role in the VICP:

    The VICP is located in the HHS, Health Resources and Services Administration, Healthcare Systems Bureau, Division of Vaccine Injury Compensation. [ Return to Text ]

  5. Pediatric Vaccines Influence Primate Behavior, and Amygdala Growth and Opioid Ligand Binding, IMFAR, May 16, 2008

    Authors: L. Hewitson , Obstetrics, Gynecology and Reproductive Sciences, University of Pittsburgh, Pittsburgh, PA B. Lopresti , Radiology, University of Pittsburgh, Pittsburgh, PA C. Stott , Thoughtful House Center for Children, Austin, TX J. Tomko , Pittsburgh Development Center, University of Pittsburgh, Pittsburgh, PA L. Houser , Pittsburgh Development Center, University of Pittsburgh, Pittsburgh, PA E. Klein , Division of Laboratory Animal Resources, University of Pittsburgh, Pittsburgh, PA C. Castro , Obstetrics, Gynecology and Reproductive Sciences, University of Pittsburgh, Pittsburgh, PA G. Sackett , Psychology, Washington National Primate Research Center, Seattle, WA S. Gupta , Medicine, Pathology & Laboratory Medicine, University of California - Irvine, Irvine, CA D. Atwood , Chemistry, University of Kentucky, Lexington, KY L. Blue , Chemistry, University of Kentucky, Lexington, KY E. R. White , Chemistry, University of Kentucky, Lexington, KY A. Wakefield , Thoughtful House Center for Children, Austin, TX

    Background: Rhesus macaques are commonly used in pre-clinical vaccine safety testing, but the the recommended infant vaccination regimen (1994-1999) and the combined childhood vaccine regimen (see: schedule for routine immunizations), rather than individual vaccines, has not been studied or tested. Abnormal brainstem structure and function have been reported in children with autism. Opioid receptors play key roles in neuro-ontogeny, are present in brainstem nuclei, and may influence aspects of autism. Childhood vaccines are a possible causal factor in autism, and abnormal behaviors and anomalous amygdala growth are potentially inter-related features of this condition.

    Objectives: The objective of this study was to compare early infant cognition and behavior with amygdala size and opioid binding in rhesus macaques receiving the recommended childhood vaccines (1994-1999), the majority of which contained the bactericidal preservative ethylmercurithiosalicylic acid (thimerosal).

    Methods: Rhesus macaques were administered the recommended infant vaccines, adjusted for age and thimerosal dose (exposed; N=13), or saline (unexposed; N=3). Primate development, cognition and social behavior were assessed for both vaccinated and unvaccinated infants using standardized tests developed at the Washington National Primate Research Center. Amygdala growth and binding were measured serially by MRI and by the binding of the non-selective opioid antagonist [11C]diprenorphine, measured by PET, respectively, before (T1) and after (T2) the administration of the combined measles-mumps-rubella vaccine (MMR).

    Results: Compared with unexposed animals, significant neurodevelopmental deficits were evident for exposed animals in survival reflexes, tests of color discrimination and reversal, and learning sets. Differences in behaviors were observed between exposed and unexposed animals and within the exposed group before and after MMR vaccination. Compared with unexposed animals, exposed animals showed attenuation of amygdala growth and differences in the amygdala binding of [11C]diprenorphine. Interaction models identified significant associations between specific aberrant social and non-social behaviors, isotope binding, and vaccine exposure.

    Conclusions: This animal model, which examines for the first time, behavioral, functional, and neuromorphometric consequences of the childhood vaccine regimen, mimics certain neurological abnormalities of autism. The findings raise important safety issues while providing a potential model for examining aspects of causation and disease pathogenesis in acquired disorders of behavior and development. [ Return to Text ]

  6. CBS News Interview with Dr. Bernadine Healy, Former Head of the National Institutes of Health, Regarding the Link Between Vaccines and Autism

    Dr. Bernadine Healy is the former head of the National Institutes of Health, and the most well-known medical voice yet to break with her colleagues on the vaccine-autism question. In an exclusive interview with CBS News correspondent Sharyl Attkisson, Healy said the question is still open. "I think that the public health officials have been too quick to dismiss the hypothesis as irrational," Healy said.

    "But public health officials have been saying they know, they've been implying to the public there's enough evidence and they know it's not causal," Attkisson said.

    "I think you can't say that," Healy said. "You can't say that." Healy goes on to say public health officials have intentionally avoided researching whether subsets of children are 'susceptible" to vaccine side effects - afraid the answer will scare the public.

    "You're saying that public health officials have turned their back on a viable area of research largely because they're afraid of what might be found?" Attkisson asked.

    Healy said: "There is a completely expressed concern that they don't want to pursue a hypothesis because that hypothesis could be damaging to the public health community at large by scaring people. "First of all," Healy said, "I think the public's smarter than that. The public values vaccines. But more importantly, I don't think you should ever turn your back on any scientific hypothesis because you're afraid of what it might show."

    Healy elaborated further, saying: "The government has said in a report by the Institute of Medicine (IOM)—and by the way, I'm a member of the Institute of Medicine; I love the Institute of Medicine—but in a report in 2004, it basically said: 'Do not pursue susceptibility groups; Don't look for those patients, those children who may be vulnerable'. I really take issue with that conclusion."

    Healy continued: "The reason why they didn't want to look for those susceptibility groups was because they were afraid if they found them—however big or small they were—that that would scare the public away. One should never shy away from science. One should never shy away from getting causality information in a setting in which you can test it. Populations do not test causality, they test associations. You have to go into the laboratory and you have to do designed research studies in animals". [ Return to Text ]

    For more of the CBS interview with Dr. Healy, watch the video below (and please forgive the 30 second commercial from CBS at the beginning):

  7. The Institute for Vaccine Safety at the Johns Hopkins Bloomberg School of Public Health has a Vaccine Table updated June, 24, 2008, Thimerosal Content in Some U.S. Licensed Vaccines Mercury Autism Research Study 68 KB

    Referring to the terms "Thimerosal-free" and "trace amounts", it notes with asterisks six vaccines (DTaP, DTaP-Hib, DT, Td, Td-Tetanus and Diphtheria Toxoids Adsorbed, and Hib) that, according to JAMA 1999;282(18) and JAMA 2000;283(16), "should be considered equivalent to thimerosal-free products." In the same notation is the disclaimer for these vaccines: "This vaccine may contain trace amounts (< 0.3 mcg) of mercury left after post-production thimerosal removal; these amounts have no biological effect."

    It also lists 10 vaccines (DTwP, DT, Tetanus Toxoid-Tetanus Toxoid Adsorbed USP, Tetanus Toxoid-Tetanus Toxoid Adsorbed Adult Use, Tetanus Toxoid-Booster, Influenza 2007/8 Formula-multi-dose-CSL Limited, Influenza 2007/8 Formula-multi-dose-FluLaval-GlaxoSmithKline, Influenza 2007/8 Formula-multi-dose-Fluvirin-Novartis, Influenza 2007/8 Formula-multi-dose-Fluzone-sanofi-pasteur, and Meningococcal-multi-dose) that still have .01% Thimerosal (25 micrograms Mercury/0.5 ml) in them. [ Return to Text ]

  8. After a 1999 review, the FDA admitted (in FDA/CBER - Thimerosal in Vaccines: Recent and Future FDA Action): "At the time of this review in 1999, the maximum cumulative exposure to mercury from vaccines in the recommended childhood immunization schedule schedule for childhood vaccinations 128 KB was within acceptable limits for the methylmercury exposure guidelines set by FDA, ATSDR, and WHO. However, depending on the vaccine formulations used and the weight of the infant, some infants could have been exposed to cumulative levels of mercury during the first six months of life that exceeded the EPA recommended guidelines for safe intake of methylmercury." [ Return to Text ]

  9. After a 1999 review, the FDA also stated (in FDA/CBER - Thimerosal in Vaccines: Thimerosal Toxicity): "The various mercury guidelines are based on epidemiological and laboratory studies of methyl mercury, whereas thimerosal is a derivative of ethyl mercury. Because they are different chemical entities - ethyl- versus methylmercury - different toxicological profiles are expected. There is, therefore, an uncertainty that arises in applying the methylmercury-based guidelines to thimerosal. Lacking definitive data on the comparative toxicities of ethyl- versus methylmercury, FDA considered ethyl- and methyl-mercury as equivalent in its risk evaluation."

    Additional information on mercury in vaccines and others sources of mercury can be found on our Vaccinations and Mercury page, which contains the following sections: [ Return to Text ]


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