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Autism and Mercury • Testimony Before Congress by Stephanie Cave, M.D.
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"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
- Bernard, S., Enayati, A., Roger, H., Redwood, L., Binstock, T. Autism: A Unique Type of Mercury Poisoning. Condensed draft of June 27, 2000.
- Kanner, L., Autistic Disturbances of Affective Contact. The Nervous Child 1942-1943;2: 217-250.
- CDC. Thimerosal in Vaccines: a Joint Statement of the American Academy of Pediatrics and the Public Health Service. MMRW 1999;48. 26:563-565.
- CDC. Recommendations Regarding the Use of Vaccines That Contain Thimerosal as a Preservative. MMWR, 1999; 48. 43. 996-998.
- Correspondence from Theresa Binstock to David Satcher, MD, PhD. July 5, 2000.
- Edelson, S.B. Mercury: The Basis Cause of Major Chronic Diseases of the New Millenium, 2000.
- 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.
- 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.
- Haley, Boyd presentation The toxic effects of oral mercury, Mercury Toxicity Workshop, Dallas, Texas, May 4, 2000.
- Aschner, Michael. Environmental mercury toxicity presentation, Mercury Toxicity Workshop, Dallas, Texas, May 4, 2000.
- Case Studies in Environmental Medicine: Mercury Toxicity, March 1992, U.S. Department of Health and Human Services.
- Special Note: Dr. Stephanie Cave presented the above testimony, Autism and Mercury, before the Committee on Oversight and Government Reform in the U.S. House of Representatives on July 18, 2000. She was one of a panel of experts on autism who spoke to Representative Dan Burton's hearing on Mercury in Medicine - Are We Taking Unnecessary Risks? (Official title and complete record, containing transcript of all testimony, prepared statements, papers submitted and copies of other exhibits: Mercury in Medicine&msdash;Are We Taking Unnecessary Risks?, Hearing Before the Committee on Govenment Reform, House of Representatives, One Hundred Sixth Congress, Second Session, July 18, 2000, Serial Number 106-232
31.5 MB ). The hearing was part of an ongoing Committee investigation into vaccine policy.The Committee held a hearing reviewing conflicts of interest on two key governmental advisory committees that make recommendations regarding vaccines. Numerous members of the committees were found to have substantial relationships with the pharmaceutical companies that manufacture vaccines.
As you may know, Congressman Dan Burton - who has an autistic grandchild - has stated that he intends to challenge the provision surreptitiously inserted into The Homeland Security Act that exempts the pharmaceutical giant, Eli Lilly, from any liability for their use of the potentially harmful mercury-based additive thimerosal in their vaccines.
Other professionals who presented testimony to Representative Burton's Committee included:
- Lyn Redwood, R.N., M.S.N., C.R.N.P.
- Sallie Bernard
- Albert Enayati, B.S., Ch.E., M.S.M.E.
- Elizabeth Birt
- Dr. H. Vasken Aposhien, Professor of Molecular and Cellular Biology and Pharmacology, University of Arizona, Tucson, Arizona
- Dr. Sharon Humiston
- Kathryn R. Mahaffey, Ph.D, Division Director, Environmental Protection Agency (EPA)
- Michael Firestone, Ph.D, Science Director, Office of Children's Health Protection, Environmental Protection Agency
- William Egan, Ph.D., Acting Office Director, Office of Vaccine Research and Review, Center for Biologics Evaluation and Research (CBER) of FDA
- Roger H. Bernier, Ph.D., M.D., Associate Director for Science at the National Immunization Program, Centers for Disease Control and Prevention (CDC)
- Marie Bristol-Power, Ph.D., National Institute of Child Health and Human Development, National Institute of Health (NIH)
- Balancing Biochemistry: An Interview with Stephanie Cave | Mothering Magazine, Issue 115, November/December 2002
Excerpt: "(MM:) How does mercury specifically affect the immune system and the enzyme system? (SC:) Mercury is a neurotoxin; it inhibits brain function in a variety of ways. It also suppresses the immune system to a certain degree. When the hepatitis B vaccine began to be administered at birth during the 1990s, we started seeing ear infections beginning around two weeks of age, which was almost unheard of before that. We started seeing many more sick children in that first month of life. We also find that these children make antibodies against their own tissue. They have antibodies to the basic myelin protein in brain tissue. These antibodies disappear after the children are treated and the mercury is eliminated. In addition, the children combine casein from dairy protein and gluten from wheat, oats, barley, and rye to naturally occurring morphine in the body. These gliadomorphin and casomorphin peptides make the children spacey and irritable. The enzyme DPPIV that would normally break down these peptides and eliminate them is inactivated by mercury and heavy metals. Subsequently, these children have higher levels of morphines in the body."
Read more ....
- Vaccines Past and Present: Autism and Immunizations, Stephanie F. Cave, M.D. | Presentation at Autism 2002 Conference
Excerpts: There have been a number of causes postulated for autism. I believe that it is generally thought that there is a genetic predisposition for these children. Dr. Andrew Wakefield, pediatric gastroenterologist in England has shown live measles particles in the small bowel of many of the autistic children that he treats. Dr. Mary Megson, developmental pediatrician, has a hypothesis that the pertussis vaccine takes vitamin A out of its binding site in cells causing problems in cellular communication. The latest and strongest explanation is that the autistic spectrum of disorders may be caused by mercury poisoning from a number of sources including the mother's amalgam fillings, RhoGam given at 28 weeks gestation to Rh Negative mothers, diet, and the ethyl mercury in the vaccines. Finally there are others who feel that the immune systems of the children are at risk because of the toxins and human fetal tissue in the vaccines.... ....Congressman Dan Burton has been an advocate for the parents for the past couple of years. He has held several congressional hearings in the Government Reform Committee on Vaccine Safety
....We are treating over 1500 children in the autistic spectrum in our office. We have learned a lot from these children but we have very few answers for these parents. Are vaccines really involved? We think so but we cannot prove cause and effect yet. We are pushing these young, underdeveloped immune systems beyond their capabilities in our zeal to keep them from being ill. Among other problems, there are not enough safety studies for the vaccines presently on the market.
Read more ....
- Questions & Answers with Dr. Stephanie Cave, BioChat - Dr. James Neubrander's Website
Excerpts: Q: I stopped vaccinating my son over a year ago after he reacted badly to his last few vaccinations. Is it safe to just keep him vaccine free while we are on the road to recovery. A little history is that my son went from pretty nt (neurologically typical) with certain delays to severely autistic within 6 hours after his MMR vaccine and DPT booster. A: For a child on the autism spectrum, I don't recommend any further vaccines.
Q: I came on late today, sorry if this was already addressed. My sons titer was negative to mumps, of course the regular pediatrician wants to redo the whole MMR vaccine. I thought single mumps shot only. Do you think it is necessary as he is a boy?
A: If the child is negative to mumps only, you would only give the mumps vaccine, not the full MMR. But if the child is ASD (Autism Spectrum Disorder), I wouldn't give any further vaccinations of any kind.
Q: Which are the best tests to do that will show if the child has heavy metal toxicity? Hair? Urine? Feces? Blood? Do you know a lab that you think has the best test / results?
A: We look at hair. We try to get the first haircut hair. If the child is not excreting mercury in first haircut hair, they're probably not an excretor. We do a challenge to see what can be pulled. We used to check stool, not so much any more. Blood only shows mercury there for a week. Doctors Data is the best lab I've seen.
Q: How long should we wait when the liver becomes weak from DMSA before continuing chelation? Also, what chelator should be used to remove mercury from brain once DMSA removes body mercury?
A: The liver shouldn't be weak from using DMSA. Use glutathione and sulfate along with chelation. You cannot remove mercury straight from the brain. Studies last fall (DMSA, DMPS, ALA) showed the mercury wasn't coming straight from the brain. We're hoping if we take from the body, eventually it will come from the brain.
Read more ....
- Dr. Stephanie Cave Presents Enlightening Data on Mercury Toxicity, Drawn Largely from the Brilliant Work of Sallie Bernard
Excerpted from Dr. O'Shea's forthcoming revised edition of "The Sanctity of Human Blood": The figure of one autistic infant for every 150 is now widely documented. Dr. Stephanie Cave presented enlightening data on mercury toxicity, drawn largely from the brilliant work of Sallie Bernard. Dr. Cave explained how:
By age two, American children have received 237 micrograms of mercury through vaccines alone, which far exceeds current EPA 'safe" levels of .1 mcg/kg. per day. That's one-tenth of a microgram, not one microgram. Three days in particular may be singled out as spectacularly toxic for infants:
- Day of birth: hepatitis B-12 mcg mercury - 25 mcg mercury (30 x safe level)
- At 4 months: DTaP and HiB on same day - 50 mcg mercury (60 x safe level)
- At 6 months: Hep B, Polio - 62.5 mcg mercury (78 x safe level)
- At 15 months the child receives another 50 mcg (41 x safe level)
These figures are calculated for an infant's average weight in kilograms for each age. These one-day blasts of mercury are called "bolus doses". Although they far exceed 'safe" levels, there has never been any research conducted on the toxicity of such bolus doses of mercury given to infants all these years.
Inconceivable: Historically, the toxicity of mercury has been known for more than a century. The Mad Hatter was more than a fantasy character from Alice in Wonderland. Mad Hatter's disease became well known in England in the mid-1800s, when hat-makers were subject to inhaling the vapors from the mercury-based stiffening compound they used on felt to make top hats.
Sources of mercury: It is interesting to learn that common household remedies that were used up into the 1960s like mercurochrome and "teething powder" were often the cause of acute mercury poisoning and disease. In the U.S., EPA mercury toxicity studies have involved contamination from fish, air, and other environmental sources. This is inorganic mercury (methylmercury). Methylmercury has long been associated with serious neurological disorders, demyelinating diseases, gut disease, and visual damage. The mercury in vaccines, however, is in the form of thimerosal, which is 50 times more toxic than plain old mercury (methylmercury). Reasons for this include:
- Injected mercury is far more toxic than ingested mercury.
- There's no blood-brain barrier in infants.
- Mercury accumulates in brain cells and nerves.
- Infants don't produce bile, which is necessary to excrete mercury.
Thimerosal is organic mercury: Once it is in nerve tissue, converted irreversibly to its inorganic form. Thimerosal is a much more toxic form of mercury than one would get from eating open-sea fish; it has to do with the difficulty of clearing thimerosal from the blood. Thimerosal is converted to ethylmercury, an organic form that has a preference for nerve cells.
Without a complete blood-brain barrier, an infant's brain and spinal cord are sitting ducks. Once in the nerve cells, mercury is changed back to the inorganic form and becomes tightly bound. Mercury can then remain for years, like a time-release capsule, causing permanent degeneration and death of brain cells. Bernard also notes that the body normally clears mercury by fixing it to bile, but before six months of age, infants don't produce bile. Result: mercury can't be excreted.
Four separate government agencies have set safe levels for methylmercury, but no safe levels have ever been set for thimerosal, because thimerosal isn't included in toxicity studies. Theoretically, that means that the above excesses of safe levels of mercury on the single days listed above are actually 50 times higher. Does the fact that the mercury is accompanied by a vaccine somehow place it above scrutiny? The Sallie Bernard study of vaccines and mercury toxicity was probably the main reason Congress began to see the obvious correlation.
Mercury And Vaccines: Here's a curious "coincidence." In the late 1930s, Leo Kanner identified autism as a new type of mental disorder. So when was thimerosal introduced into vaccines? The 1930s.
A few years ago, Bernard and her associates began to notice a striking similarity between the symptoms of autism and the symptoms of mercury poisoning. The more research she did, the more it seemed that these two diseases were virtually identical. Autism and mercury poisoning damage:
- the brain/nerve cells
- the eyes
- the immune system
- thegastrointestinal system
- muscle control
- the speech center.
Although mercury toxicity has been studied for decades, and EPA safety levels have been set, during all that time a child's greatest exposure to mercury—thimerosal in vaccines&mdashwas never even included in the toxicity studies. The talk has always been about methylmercury from seafood and the environment, totally ignoring the two most toxic sources of mercury for children: vaccines and dental amalgams.
The EPA has no jurisdiction over drugs: That's the FDA's job. This is why vaccines and amalgams don't even figure into the equation when it comes to setting 'safe" levels of mercury. But the FDA does have jurisdiction over drugs and drug companies, right? And over drug company publications, like the Merck Manual, the standard cookbook for drugs and diseases found in every doctor's office in the world. Surely the FDA, as the government agency charged with safeguarding the nation's health, would want the section on mercury toxicity to warn doctors about the two biggest sources for children: thimerosal and dental amalgams, wouldn't you think?
Yet looking at the Merck Manual (1999), in the section on mercury poisoning (p. 2636), thimerosal and dental amalgams again are not even mentioned. How can this be, when mercury is widely acknowledged as the third most deadly toxin in the world and thimerosal and amalgams dwarf the trace amounts of mercury from fish and other environmental sources of mercury? Only one thing can a blackout information over an entire area of study for years at a time in this way - big money.
Such an omission probably wouldn't have anything to do with the revolving door that exists between the FDA; the EPA; the NIH —
"...and the sweet positions held by their members before and after those grueling years of public service; or with the 800 waivers of the conflict of interest rule that the FDA has granted in the past two years to "experts," who are paid consultants to the drug companies-consultants who are also members of the FDA advisory committees that make decisions about whether or not to approve vaccines and drugs...".The experts are supposed to be independent, but USA TODAY found that 54% of the time, they have a direct financial interest in the drug or topic they are asked to evaluate. These conflicts include helping a pharmaceutical company develop a medicine, then serving on an FDA advisory committee that judges the drug. (USA Today, Sept. 25, 2000)
Soaking up the Mercury: In the San Diego conference on autism, Dr. Amy Holmes gave perhaps the only lucid presentation about treatment. She explained how chelating drugs alone, which go through the blood like Pac Man munching up mercury, don't do much good for autism. That's because most mercury clears from the blood very soon. Mercury in thimerosal is stored in the gut, liver and brain, and as previously mentioned, becomes very tightly bound to the cells. Once inside those cells, or inside the blood-brain barrier, the mercury is reconverted back to its inorganic form.
Locked into these cells, the mercury can then do either immediate cell damage or become latent and cause the onset of autism, brain disorders, or digestive chaos years later. Dr. Holmes reported success using alphalipoic acid as an agent to cross the blood-brain barrier to soak up mercury. Once the mercury is brought back into the bloodstream, standard chelators like DMSA can then take it out.
Read more ....
- Autism: A Unique Form of Mercury Poisoning (formerly cited as: Autism: A Novel Form of Mercury Poisoning)
The original version of this research paper by Sallie Bernard, Albert Enayati, Teresa Binstock, Heidi Roger, Lyn Redwood and Woody McGinnis, was also presented along with Dr. Stepanie Cave's Testimony at the Hearing Before the Committee on Govenment Reform in House of Representatives, by Sallie Bernard. This updated version, excerpted below, is from the Autism Reasearch Institute (ARI) | Possible Triggers of Autism | Vaccinations. Discussion: How reasonable is it to claim that the most common form of autism, where there is normal development and then regression, could be caused by mercury poisoning? There are several reasons to believe that this process has indeed occurred.
- Diagnostic Criteria Are Met: Medical literature demonstrates that mercury can induce autism-spectrum traits, and this association extends to mercury's localization within specific brain nuclei. In attempting to address "the totality of the syndrome" (Bailey et al, 1996), we have shown that every major characteristic of autism has been exhibited in at least several cases of documented mercury poisoning, and that every major area of biological and neurological impairment implicated in ASD has been observed with Hg exposure. Recently, government-directed studies have revealed that the amount of mercury given to infants receiving vaccinations exceeds safety levels. The timing of mercury administration via vaccines coincides with the onset of autistic symptoms. Case reports of autistic children with measurable mercury levels in hair, blood, and urine indicate a history of mercury exposure along with inadequate detoxification. Thus the standard criteria for a diagnosis of mercury poisoning in autism, as outlined at the beginning of this paper, are met. In other words, mercury toxicity is a significant contributing factor or primary etiological factor in many or most cases of autism.
- Unique Form Would be Expected, Implicates Vaccinal Thimerosal: Symptoms manifested in mercury poisoning are diverse and vary by the interaction of variables such as type of mercury, age of patient, method of exposure, and so forth. Thus, although it could be argued that in all the thousands of cases of past Hg poisonings, no instance of autism could be found, such an argument fails to take into account the possibility of unique expression. It would be comparable to saying that, because in all the cases of Minamata disease no instance of acrodynia could be found, then acrodynia could not be caused by mercury poisoning. Since there are no case reports or systematic studies in the literature of the effects of intermittent bolus doses of injected ethylmercury on 'susceptible" infants and toddlers, it would be reasonable to expect that symptoms arising from this form of mercury poisoning would present as a novel disease. In fact, given the high neurotoxicity of organic mercury, its known psychological effects, and the age at which it has been given in vaccines, it would almost be a given that the "novel disease" would present as a neurodevelopmental disorder like autism.
Conversely, the fact that autism meets the diagnostic criteria for mercury poisoning, yet has never been described as a mercury-induced disease, requires that the disorder must arise from a mode of mercury administration which has not been studied before. This would rule out other known sources of Hg like fish consumption or occupational mercury hazards, as these have been well characterized. It is possible that another under-investigated mercury route, such as maternal Hg exposures (e.g., from vaccinations, thimerosal-containing RhoGam injections during pregnancy, or dental fillings) or infant exposures to thimerosal-containing eardrops or eyedrops, might be a factor, and this cannot be ruled out.
- Historical Precedent Exists: There is a precedent for large scale, undetected mercury poisoning of infants and toddlers in the syndrome that came to be known as acrodynia or pink disease. For over 50 years, tens of thousands of children suffered the bewildering, debilitating, and often life-long effects of this disease before its mercury etiology was established, as Ann Dally relates in The Rise and Fall of Pink Disease [Social History of Medicine 1997 10(2):291-304].
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- Dan Burton Calls for Criminal Penalties for Any Government Agency that Knew About the Dangers of Thimerosal in Vaccines
WFAA-TV News, Dallas/Fort Worth, June 2002: United States Congressman Dan Burton from Indiana is calling for criminal penalties for any government agency that knew about the dangers of thimerosal in vaccines, and did nothing to protect American children. Last month, a News 8 Investigation disclosed allegations that some government officials may have suppressed documentation about the risks. Some of those officials testified at Wednesday's congressional hearing. News 8 research showed that the FDA began asking questions about the dangers of thimerosal back in 1972. By 1992, the preservative had been pulled out of dog vaccines and contact lens solutions because of the risks. However, thimerosal remained in vaccines for children until last year [Note: As of 7/4/2008, Thimerosal is still contained in some children's vaccines as well as many flu shots - See the CDC Thimerosal in Vaccines Tables below]. Government health officials squirmed uncomfortably in their seats Wednesday as more evidence emerged suggesting that they misled the public. "You mean to tell me that since 1929, we've been using thimerosal," Congressman Dan Burton (R-Indiana) said to the officials, "and the only test that you know of is from 1929, and every one of those people had meningitis, and they all died?"
For nearly an hour, Burton repeatedly asked FDA and CDC officials what they knew and when they knew it. And when memories seemed to be a bit fuzzy, the congressman produced old memos as a refresher. One memo, from 1999, states that the FDA had an "interim plan ... already in place for many years" to get rid of thimerosal. The same e-mail also addresses the FDA's fear that it will be accused by the public of being "asleep at the switch for decades, by allowing a dangerous compound to remain in childhood vaccines". Burton has proposed bringing criminal charges if it's proven the government agencies were involved in a cover-up.
Government accountability is something that parents of autistic children have been asking for for years. Cooper Earp, 7, had lost his ability to talk by age three, and his mercury levels were off the charts. His parents said Cooper's only exposure to mercury was through his vaccines. Today, he has all the classic signs of autism, such as repeatedly hitting himself, and fixating on such things as a spinning chair. Cooper's mother Kristi Earp has a dream that one day Cooper will call her "mommy" in a sentence.
Parents like Earp would like to ask the panel of government officials why, in eighty years, they never ordered one clinical test on the effects of thimerosal in vaccines. Burton asked the question several times Wednesday, but never got a direct answer. After the hearing, News 8 asked the same question of an official, walking briskly down a corridor. "You have to call the press office," an assistant replied.
Burton has a personal stake in the growing scandal: he said his grandson became autistic a few days after receiving nine inoculations. Thus far, within the government, Burton has been a minority voice, but he has subpoena power, and he keeps threatening to use it. 'so what you do is keep making the case, and keep trying to get the message out to a broader and broader audience so that people start saying 'Why?'," Burton said. "When enough people say 'Why?', change starts to take place."
In the Congressional hearings, Burton went on to say, "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 [of Health and Human Services] 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."
Press Release, Washington, January 9, 2003: U.S. Senator Debbie Stabenow (D-MI) said today the fight to remove special interest provisions from the Homeland Security bill - such as the one protecting Eli Lilly and Co. from all lawsuits arising from the use of the compound thimerosal - will be among her first legislative actions of the 108th Congress. In addition to warping the legislative process by inserting special interest provisions in an essential piece of legislation, the House leadership also denied due process to families who wished to pursue legal claims over the potential dangers of thimerosal, Stabenow said. "Don't families and their children merit due process under the law?" Stabenow asked. "The provision approved in the Homeland Security bill would severely limit parents' ability to get justice for their children.
Stabenow was joined at the press conference by other strong critics of the Eli Lilly provision, including U.S. Senator Patrick Leahy (D-VT) and Representative Dan Burton (R-IN). Also participating were representatives from Consumers Union, from the Mercury Policy Project - a group devoted to raising awareness about the threat of mercury contamination - and Lyn Redwood, co-founder and President of the Coalition for SafeMinds and the parent of an autistic child, who believes her child's autism may be linked to the use of thimerosal and who believes that manufacturers of the compound should be held accountable. (Burton has stated that he intends to challenge the provision surreptitiously inserted into The Homeland Security Act that exempts the pharmaceutical giant, Eli Lilly, from any liability for their use of the potentially harmful mercury-based additive thimerosal in their vaccines. 1)
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- Children's Vaccine Manufacturer Granted Immunity, Eli Lilly, Knew of Thimerosal Dangers for Decades, June 18, 2008
Full Text: In 2005, Robert F. Kennedy, Jr. published Deadly Immunity, a lengthy examination of the history of Eli Lilly's deadly mercury compound, Thimerosal, in vaccines and its decades-long history of suppressed data about dangers to those receiving it. The piece described the outcome of a secret, highly-secluded 2000 meeting—The Simpsonwood Conference—involving a group of government scientists and health officials convened by the Centers for Disease Control and Prevention (CDC).
Internal Eli Lilly documents revealed by the Kennedy paper show the company knew immediately that its product—Thimerosal—could cause damage, even death, in animals and humans In its apparent eagerness to promote and market the product, in September, 1930, Eli Lilly secretly sponsored a "human toxicity" study on patients already known to be dying of meningococcal meningitis. Senior partner Andrew Waters (of the Dallas-based law firm of Waters & Kraus, that received the documents as a result of the discovery process in the case of Counter v. Eli Lilly & Company, et al) stated that, "Lilly then cited this study repeatedly for decades as proof that thimerosal was of low toxicity and harmless to humans. They never revealed to the scientific community or the public the highly questionable nature of the original research." In 1935, researchers at vaccine manufacturer, Pittman-Moore, warned Lilly that its claims about Thimerosal's safety "did not check with ours." In a study by Dr. John C. Pittman at the Carolina Center for Integrative Medicine conducted with dogs injected with thimerosal-based vaccines, half of the dogs fell ill prompting researchers to "declare the preservative 'unsatisfactory as a serum intended for use on dogs." [A new—May 2008—similar study by the University of Pittsburgh on the effects of thimerosal on primates (Rhesus macaques) showed thimerosal caused autism-like symptoms.
The mounting case against Thimerosal did not stop in the 1930s. During WWII, the Department of Defense used Thimerosal in vaccines on soldiers but required Lilly to label it "poison." In 1967, a study in Applied Microbiology [see also: Documents on the Adverse Effects of Thimerosal (Mercury, Merthiolate, Ethyl Mercury) Showing Gastrointestinal Abnormalities and Immune System Irregularities in Autistic Children
Horribly, in 1991, the CDC recommended "infants be injected with a series of mercury-laced vaccines: Newborns would be vaccinated for hepatitis B within 24 hours of birth; two-month-old infants would be immunized for haemophilus influenzae B and diphtheria-tetanus-pertussis (DPT)." The same year, Dr. Maurice Hilleman, a Merck Vaccine Program luminary, warned Merck that six-month-olds administered Thimerosal-laced shots would "suffer dangerous exposure to mercury" and recommended Thimerosal be discontinued, "especially when used on infants and children," noting the industry knew of nontoxic alternatives. "The best way to go," he added, "is to switch to dispensing the actual vaccines without adding preservatives."
Thimerosal enables big pharmaceutical companies to package vaccines in multi-dose vials costing half as much as smaller, single-dose vials, cutting costs for international agency distribution to impoverished areas. Money prompted Merck to ignore Hilleman. Government officials pushed Thimerosal-laced vaccines and by 1999, children received an unbelievable 22 immunizations by the time they reached first grade. Before 1989, American preschoolers received eleven vaccinations: polio (IPV), diphtheria-tetanus-pertussis (DPT) and measles-mumps-rubella (MMR).
- Petition from the Coalition for Mercury-free Drugs (CoMeD) to the FDA and Department of Health & Human Services
Excerpts: 1. General Background: The compound, ethyl(2-mercaptobenzoato-S)mercury sodium salt or, more commonly named, sodium ethylmecurithiosalicylate, patented as a topical anti-infective in 1928 and known by many trade names, including Thimerosal, has been used since the 1930's. Subsequently, Thimerosal came to be widely accepted as a "preservative" component in some of the vaccines and other drugs intended for use in humans. Moreover, though not labeled as such, Thimerosal (at levels from 0.01 % [100 ppm] down to "0.0002 % [2 ppm]" in vaccine formulations) seems to function as an "adjuvant."
From the 1980's to present, the Centers for Disease Control and Prevention (CDC) and the FDA have allowed: a) the administration of Thimerosal-preserved RhoD and other biological preparations to pregnant women and b) the immunization of newborns and young children with Thimerosal-preserved vaccines that, in both instances, contain levels of Thimerosal that exceed EPA's implicit safety limits for mercury exposure. Today, a range of multi-dose vaccines and related biological products that contain levels of Thimerosal above 0.001 % (10 ppm) are still produced, licensed or approved, and available for unrestricted use in humans.
2. Removal Of Thimerosal And Other Mercury-based Compounds From OTC Drugs: In 1982, a scientific panel, convened by the FDA to review the over-the-counter (OTC) use of Thimerosal, concluded,11 "that thimerosal is not safe for [over-the-counter] topical use because of its potential for cell damage if applied to broken skin and its allergy potential." [Note: This FDA-sponsored panel only addressed the epidermal and dermal effects of Thimerosal.] Based on the results of their review, that scientific panel recommended the removal of Thimerosal from over-the-counter products. Sixteen years later, in 1998, the FDA finally banned12 the use of:
- Thimerosal and any other ingredient containing mercury in OTC "topical antimicrobial" products, and
- Phenylmecuric acetate, phenylmecuric nitrate, and any other ingredient containing mercury in "vaginal contraceptive" products. [See 21 C.F.R. Section 310.545.]
3. Petitioners' General Concerns: Of general concern to these petitioners are the facts that:
- Today, Thimerosal's mercury-containing metabolites, ethyl mercury and ionic mercury, are known neurotoxins at levels below 0.1 part per million (0.1 ppm; 0.1 µg/mL in liquids or 0.1 µg/g in solids), and
- When Thimerosal is present at 0.01 %, as it commonly is in multi-dose vaccine formulations and other similarly preserved biological preparations, the effective level of "mercury" added to such formulations is about 50 parts per million (50 ppm; 50 µg/mL or 50 µg/g).
In spite of the preceding facts, the manufacturers have failed, as far as we have been able to ascertain, to establish the intrinsic safety of formulations containing added Thimerosal, a known neurotoxic compound, at the 0.01% level or, for that matter, at lower levels. We find that the safety of each formulation has not been scientifically established in the appropriate rigorous comparative toxicology studies (comparing the acute and chronic neurotoxicity of the formulation with added Thimerosal to the neurotoxicity of the same formulation without Thimerosal) using an appropriate mercury-susceptible cellular or animal model.
Inexplicably, the preceding safety-study data is deficient or non-existent even though the regulations for drugs, including vaccines and other biological preparations classified as drugs, explicitly require that all drugs (as that term is defined in 21 U.S.C. Section (§) 321(g)(1)13, including any component used in a drug [21 U.S.C. § 321(g)(1)(D)]) must be safe (based on the definition of safe in 21 U.S.C. § 321(u)14) and effective in humans and animals.
In addition, the regulations governing "Preservatives in Vaccines" (contained in Section 610.15 of the Code of Federal Regulations [21 C.F.R. § 610.15]) explicitly require that "any preservative used shall be sufficiently nontoxic so that the amount present in the recommended dose of the product will not be toxic to the recipient"15.
Thus, as far as we have been able to ascertain, the maximum level of Thimerosal present in today's Thimerosal-preserved drug products (0.01% [100 micrograms per milliliter or gram of drug product]) has not been proven safe.
- Simpsonwood & Related Documents - Scientific Review of Vaccine Safety Datalink Information, June 7-8, 2000, Simpsonwood Retreat Center, Norcross, Georgia
From the Coalition for SafeMinds (Sensible Action For Ending Mercury-Induced Neurological Disorders)
According to the CDC 'simpsonwood transcripts," the link between neurodevelopmental disorders and thimerosal (a vaccine preservative that contains mercury) is 'statistically significant." These transcripts were originally on the CDC website at http://www.cdc.gov/nip/news/simptrans072005.htm, but that url now redirects to a separate CDC website (http://www2a.cdc.gov as opposed the public http://www.cdc.gov) where it is noted that perhaps "the current record has been deleted". There is currently only one reference to 'simpsonwood" on the CDC website, where on the CDC's Vaccine Safety - Concerns - Timeline: Thimerosal in Vaccines (1999-2008) page, it is noted that on June 7 and 8, 2000, "Fifty-one vaccine and vaccine safety researchers and experts meet at the Simpsonwood Retreat Center in Atlanta, Georgia to review data regarding thimerosal in vaccines and nervous system disorders. A report summarizing the meeting was presented to ACIP 2". No additional information or details are given. However, thanks to the Coalition for SafeMinds and the Freedom of Information Act (FOIA), we now have that additional information and details:
Congress mandated the FDA and other health agencies under its purview to establish levels of heavy metals in pharmaceutical agents in the 1997 FDA Modernization Act. The FDA and CDC were then obliged to study the issue of Thimerosal toxicity. Their troubling findings were discussed at a meeting in June 2000 at the Simpsonwood Resort in Norcross, Georgia, where the finding of the Vaccine Safety Datalink analysis of Thimerosal-containing vaccines and neurodevelopmental outcomes were reviewed by a panel of experts. The transcript of this meeting, obtained by SafeMinds
Additionally, comments as reported by the Detroit News have been distilled into a short form along with other pertinent highlights of this landmark meeting
Following their initial review, the CDC revised the data by including younger infants (not yet diagnosed) and pulled in data that knowingly and dramatically under-reported autism rates (due to a poorly designed database) and used these "new" calculations in the second and third drafts of this report. Internal e-mails from the Centers for Disease Control in Atlanta, obtained by SafeMinds under the Freedom of Information Act (FOIA), appear to confirm this suspicion. The addition of this knowingly flawed data allowed for a revised, and inaccurately lower, rate of neurodevelopmental disorders/injury secondary to Thimerosal/vaccine exposure.
Here are some example excerpts of the discussion among the doctors attending the Simpsonwood meeting that someone might find "disturbing", including the statement by one of the doctors that he wanted to be sure that his grandson - born that morning - did not receive a vaccine containing Thimerosal:
Dr. Weil: Page 24 (after Dr. Johnson: Page 16 comments made in reference to a prior meeting on thimerosal and Dr. Johnson: Page 20: referring to the mixture of both aluminum and mercury in vaccines): "One, up until this last discussion we have been talking about chronic exposure. I think it's clear to me anyway that we are talking about a problem that is probably more related to bolus acute exposures, and we also need to know that the migration problems and some of the other developmental problems in the central nervous system go on for quite a period after birth. But from all of the other studies of toxic substances, the earlier you work with the central nervous system, the more likely you are to run into a sensitive period for one of these effects, so that moving from one month or one day of birth to six months of birth changes enormously the potential for toxicity. There are just a host of neurodevelopmental data that would suggest that we've got a serious problem. The earlier we go, the more serious the problem. The second point I could make is that in relationship to aluminum, being a nephrologist for a long time, the potential for aluminum and central nervous system toxicity was established by dialysis data. To think there isn't some possible problem here is unreal."Discussion comments made by participants after the presentations:
Dr. Johnson: Page 198: "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 the diagnoses justifies compensation in the Vaccine Compensation Program at this point. I deal with causality, it seems pretty clear to be 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 there are probably implications for this internationally, but in the meantime I think I want that grandson to only be given Thimerosal-free vaccines."
Dr. Weil: Page 207: "The number of dose related relationships are linear and statistically significant. You can play with this all you want. They are linear. They are statistically significant. The positive relationships are those that one might expect from the Faroe Islands studies 3. They are also related to those data we do have on experimental animal data and similar to the neurodevelopmental tox data on other substances, so that I think you can't accept that this is out of the ordinary. It isn't out of the ordinary. The Seychelles Island studies 3 and somebody said the Faroe Islands studies 3 both, were chronic exposures. We are not talking necessarily about chronic exposure. We are talking about a series of acute exposures and at one point in time that exposure is much greater on one day than any of the Seychelles Islands. The increased incidence of neurobehavioral problems in children in the past few decades is probably real... I work in the school system where my effort is entirely in special education and I have to say that the number of kids getting help in special education is growing nationally and state by state at a rate we have not seen before.
Dr. Weil: Page 208: "The rise in the frequency of neurobehavioral disorders whether it is ascertainment or real, is not too bad. It is much too graphic. We don't see that kind of genetic change in 30 years."
Dr. Brent: Page 229: "The medical legal findings in this study, causal or not, are horrendous and therefore, it is important that the suggested epidemiological, pharmacokinetic, and animal studies be performed. If an allegation was made that a child's neurobehavioral findings were caused by Thimerosal-containing vaccines, you could readily find a junk scientist who would support the claim with "a reasonable degree of certainty". But you will not find a scientist with any integrity who would say the reverse with the data that is available. And that is true. So we are in a bad position from the standpoint of defending any lawsuits if they were initiated and I am concerned."
Dr. Clements: Page 247: "I am really concerned that we have taken off like a boat going down one arm of the mangrove swamp at high speed, when in fact there was not enough discussion really early on about which way the boat should go at all. And I really want to risk offending everyone in the room by saying that perhaps this study should not have been done at all, because the outcome of it could have, to some extent, been predicted, and we have all reached this point now where we are left hanging, even though I hear the majority of consultants say to the Board that they are not convinced there is a causality direct link between Thimerosal and various neurological outcomes.
I know how we handle it from here is extremely problematic. The ACIP is going to depend on comments from this group in order to move forward into policy, and I have been advised that whatever I say should not move into the policy area because that is not the point of this meeting. But nonetheless, we know from many experiences in history that the pure scientist has done research because of pure science. But that pure science has resulted in splitting the atom or some other process which is completely beyond the power of the scientists who did the research to control it. And what we have here is people who have, for every best reason in the world, pursued a direction of research. But there is now the point at which the research results have to be handled, and even if this committee decides that there is no association and that information gets out, the work that has been done and through the freedom of information that will be taken by others and will be used in ways beyond the control of this group. And I am very concerned about that as I suspect it is already too late to do anything regardless of any professional body and what they say..."
Dr. Bernier: Page 113: "We have asked you to keep this information confidential. We do have a plan for discussing these data at the upcoming meeting of the Advisory Committee on Immunization Practices on June 21 and June 22. At that time CDC plans to make a public release of this information, so I think it would serve all of our interests best if we could continue to consider these data. The ACIP work group will be considering also. If we could consider these data in a certain protected environment. So we are asking people who have a great job protecting this information up until now, to continue to do that until the time of the ACIP meeting. So too basically consider this embargoed information. That would help all of us to use the machinery that we have in place for considering these data and for arriving at policy recommendations."
Read more ....
- Mitochondrial Disorder? Government Concedes Vaccine-Autism Case in Federal Court, David Kirby, Huffington Post
When the parents of Hannah Poling, a nine-year-old, Athens, Ga., girl who was diagnosed with autism just after the age of two, announced that a federal vaccine injury court had awarded them a settlement, the case reignited a decade-old debate about whether vaccines could potentially trigger the disorder (somewhat lost in much of the coverage of the case was a little-known condition that the court said was aggravated by the vaccine, and which gave Hannah the features of autism). In July 2000, at 19 months of age, Poling received five vaccines containing nine immunizations—including inoculations against Diphtheria, Tetanus and Pertussis (DTP or DTaP vaccine), Hepatitis B, Rubella (German measles), Mumps, Polio (IPV vaccine), Haemophilus influenzae (Hib vaccine) and chicken pox. The girl had been developing normally, according to her parents—her father, Jon, is a Johns Hopkins-trained, practicing neurologist, her mother is an attorney and registered nurse—but in the months after the shots, she developed a fever and litany of other symptoms: diarrhea, appetite loss and intermittent screaming. A pediatric neurologist examining her in February 2001 later noted that she had lost some of the speech she had previously acquired, was no longer making eye contact, and was no longer sleeping through the night.
In its November 2007 decision the vaccine court said that the inoculations Poling received in July 2000 worsened her underlying mitochondrial disorder (which was discovered nearly a year later) and led to brain disease that appeared as symptoms of autism. The unprecedented concession 4 was filed on November 9, and sealed to protect the plaintiff's identify. It was obtained through individuals unrelated to the case.
The claim, one of 4,900 autism cases currently pending in Federal "Vaccine Court," was conceded by US Assistant Attorney General Peter Keisler and other Justice Department officials, on behalf of the Department of Health and Human Services, the "defendant" in all Vaccine Court cases. The child's claim against the government—that mercury-containing vaccines were the cause of her autism—was supposed to be one of three "test cases" for the thimerosal-autism theory currently under consideration by a three-member panel of Special Masters, the presiding justices in Federal Claims Court. Keisler wrote that medical personnel at the HHS Division of Vaccine Injury Compensation (DVIC) 4 had reviewed the case and "concluded that compensation is appropriate."
On Friday, February 22, 2008, HHS conceded that this child's complex partial seizure disorder was also caused by her vaccines. Although her seizures did not begin until six years after the date of vaccination, the government acknowledges they were, indeed, linked to the immunizations of July, 2000.
Read more ....
- Infant Vaccines Produce Autism Symptoms in New Primate Study by University of Pittsburgh Scientists, May 19, 2008
Findings from the University of Pittsburgh study, Pediatric Vaccines Influence Primate Behavior, and Amygdala Growth and Opioid Ligand Binding 5, released Friday, showed that infant monkeys given vaccines officially recommended by the CDC and the American Academy of Pediatrics (AAP) exhibited autism-like symptoms. Lead investigator Laura Hewitson of the and colleagues presented study results at the International Meeting for Autism Research (IMFAR) in London. Safety studies of medicines are typically conducted in monkeys prior to use in humans, yet such basic research on the current childhood vaccination regimen has never before been done.
The abstracts presented at IMFAR, the world's top autism science conference, describe biological changes and altered behavior in vaccinated macaques that are similar to those observed in children with autism. Unvaccinated animals showed no such adverse outcomes. The vaccines given were those recommended for U.S. infants in the 1990s, including several with the mercury preservative thimerosal and the Measles-Mumps-Rubella (MMR) vaccine. Rates of autism spectrum disorder among children born in the 1990s surged dramatically, from about 1 in 5,000 to 1 in 150 children.
"This research underscores the critical need for more investigation into immunizations, mercury, and the alterations seen in autistic children," stated Lyn Redwood, director of SafeMinds. SafeMinds calls for large scale, unbiased studies that look at medical conditions associated with autism and the effects of vaccines given as a regimen. The group's request for research echoes that of Dr. Bernadine Healy, Former NIH Director, in a CBS interview 6
video earlier this week. She asserted that public health officials have been too quick to dismiss an autism-vaccine connection when the research has been insufficient. The government recently conceded a federal vaccine court case which agreed that a child regressed into autism as a result of 9 vaccines given on one day.
Read more ....
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.
- Please be aware that the FDA, when referring to "Preservative Free (Trace Thimerosal)" below, defines the use of the word "trace" in the tables below as "1 microgram of mercury per dose or less". 7
- The Environmental Protection Agency (EPA) methylmercury guideline is a recommended limit on mercury consumption based on bodyweight, also known as a "reference dose." EPA's methylmercury reference dose is 0.1 micrograms/kg body weight per day (a kilogram is approximately 2.2 pounds - here is a pounds to kilograms conversion chart). The EPA's reference dose is for oral consumption, as opposed to the bolus injection of mercury into the body by vaccination. 8
- Thimerosal is approximately 50% mercury (Hg) by weight. A 0.01% solution (1 part per 10,000) of thimerosal contains 50 micrograms of Hg per 1 mL dose or 25 micrograms of Hg per 0.5 mL dose.
- The metabolite of Thimerosal is ethylmercury (ethyl mercury) rather than methylmercury. In defending its use of Thimerosal as a preservative in vaccines, the FDA states: "there are no existing guidelines for ethylmercury". 9
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:
- Table 1. Thimerosal Content of Vaccines Routinely Recommended for Children 6 Years of Age and Younger
- Table 2: Preservatives Used in U.S. Licensed Vaccines
- 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
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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:
"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." |
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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 rel
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