Through this investigation of pediatric vaccine safety, the following findings are made:
1. Mercury is hazardous to humans. Its use in medicinal products is undesirable, unnecessary and should be minimized or eliminated entirely.
2. For decades, ethylmercury was used extensively in medical products ranging from vaccines to topical ointments as preservative and an anti-bacteriological agent.
3. Manufacturers of vaccines and thimerosal, (an ethyl-mercury compound used in vaccines), have never conducted adequate testing on the safety of thimerosal. The FDA has never required manufacturers to conduct adequate safety testing on thimerosal and ethyl-mercury compounds.
4. Studies and papers documenting the hyperallergenicity and toxicity of thimerosal (ethylmercury) have existed for decades.
5. Autism in the United States has grown at epidemic proportions during the last decade. By some estimates the number of autistic children in the United States is growing between 10 and 17 percent per year. The medical community has been unable to determine the underlying cause(s) of this explosive growth.
6. At the same time that the incidence of autism was growing, the number of childhood vaccines containing thimerosal was growing, increasing the amount of ethyl mercury to which infants were exposed threefold.
7. A growing number of scientists and researchers believe that a relationship between the increase in neuro-developmental disorders of autism, attention deficit hyperactive disorder, and speech or language delay, and the increased use of thimerosal in vaccines is plausible and deserves more scrutiny. In 2001, the Institute of Medicine determined that such a relationship is biologically plausible, but that not enough evidence exists to support or reject this hypothesis.
8. The FDA acted too slowly to remove ethylmercury from over-the-counter products like topical ointments and skin creams. Although an advisory committee determined that ethylmercury was unsafe in these products in 1980, a rule requiring its removal was not finalized until 1998.
9. The FDA and the CDC failed in their duty to be vigilant as new vaccines containing thimerosal were approved and added to the immunization schedule. When the Hepatitis B and Haemophilus Influenzae Type b vaccines were added to the recommended schedule of childhood immunizations, the cumulative amount of ethylmercury to which children were exposed nearly tripled.
10. The amount of ethylmercury to which children were exposed through vaccines prior to the 1999 announcement exceeded two safety thresholds established by the Federal government for a closely related substance–methylmercury.
While the Federal Government has established no safety threshold for ethylmercury, experts agree that the methyl mercury guidelines are a good substitute. Federal health officials have conceded that the amount of thimerosal in vaccines exceeded the EPA threshold of 0.1 micrograms per kilogram of bodyweight. In fact, the amount of mercury in one dose of DTaP or Hepatitis B vaccines (25 micrograms each) exceeded this threshold many times over. Federal health officials have not conceded that this amount of thimerosal in vaccines exceeded the FDA’s more relaxed threshold of 0.4 micrograms per kilogram of body weight. In most cases,however, it clearly did.
11. The actions taken by the HHS to remove thimerosal from vaccines in 1999 were not sufficiently aggressive. As a result, thimerosal remained in some vaccines for an additional two years.
12. The CDC’s failure to state a preference for thimerosal- free vaccines in 2000 and again in 2001 was an abdication of their responsibility. As a result, many children received vaccines containing thimerosal when thimerosal-free alternatives were available.
13. The Influenza vaccine appears to be the sole remaining vaccine given to children in the United States on a regular basis that contains thimerosal. Two formulations recommended for children six months of age or older continue to contain trace amounts of thimerosal. Thimerosal should be removed from these vaccines. No amount of mercury is appropriate in any childhood vaccine.
14. The CDC in general and the National Immunization Program in particular are conflicted in their duties to monitor the safety of vaccines, while also charged with the responsibility of purchasing vaccines for resale as well as promoting increased immunization rates.
15. There is inadequate research regarding ethyl-mercury neurotoxicity and nephrotoxicity.
16. There is inadequate research regarding the relationship between autism and the use of mercury-containing vaccines.
17. To date, studies conducted or funded by the CDC that purportedly dispute any correlation between autism and vaccine injury have been of poor design, under-powered, and fatally flawed. The CDC’s rush to support and promote such research is reflective of a philosophical conflict in looking fairly at emerging theories and clinical data related to adverse reactions from vaccinations.
One study that compared the toxicology of ethyl and methyl-mercury was published in 1985 in the Archives of Toxicology, written by researchers from the Toxicology Unit of the Medical Research Council of England. The researchers exposed rats to ethyl and methyl-mercury to “compare total and inorganic mercury concentrations in selected tissues, including the brain, after the daily administration of methyl or ethyl-mercury and to relate these findings to damage in the brain and kidneys.” This study found that both ethyl and methyl-mercury caused damage to the brains and the kidneys. It also found that male and female rats were affected differently: “It has been well documented that one of the first toxic effects of methylmercury in rats is depressed weight gain or even weight loss . . . based on this criteria, ethyl-mercury proved to be more toxic than methylmercury . . . in both sexes . . . the concentration of total mercury (the sum of organic and inorganic mercury) and organic mercury was consistently higher in the blood of ethylmercury-treated rats . . . both alkymercurials damaged the dorsal root ganglia and 9.6 mg Hg/kg/day ethylmercury caused more damage than 8.0 mg Hg/kg/day methylmercury. Ethylmercury was more renotoxic than methyl-mercury . . . tubular dilation was frequently present . . . in kidneys . . . both damage and mercury deposits were more widely spread in ethylmercury-treated rats.”
While there is frequent reference to the paucity of science in understanding the harm that ethyl-mercury can do, there is more understanding in the scientific community than government officials have shared with the Committee.
The mercury amalgams in your mouth, the so-called silver fillings, contain 48 to 50 percent of elemental mercury.
These fillings continuously emit mercury vapor, which will go to the brain and is converted to mercuric mercury . . .
Certain fish contain methylmercury; again, very rapidly taken up from the GI tract, transported quickly to the brain, and converted very slowly to mercuric mercury . . . thimerosal, which again will be taken up by the brain and quickly converted to mercuric mercury–all three forms are neurotoxic.
“By neurotoxic, we mean it will damage nerves and it will damage brain tissues.”
“Let me just say as a final statement that there is no need to have thimerosal in a vaccine.”
In making a presentation to the Institute of Medicine’s Immunization Safety Review Committee, in July 2001, the former Director of the Environmental Toxicology Program at the National Institutes of Health, Dr. George Lucier, proffered the following conclusions:
- Ethyl-mercury is a neurotoxin.
- Infants may be more susceptible than adults.
- Ethyl-mercury should be considered equipotent to methyl-mercury as a developmental neurotoxin. This conclusion is clearly public health protective.
- Ethyl-mercury exposure from vaccines (added to dietary exposures to methylmercury) probably caused neurotoxic responses (likely subtle) in some children.
While the debate over whether ethyl or methylmercury is more toxic will probably not be resolved in the near future, a consensus appears to be emerging that exposure to these different types of mercury cannot be considered in isolation.
Rather, witnesses before the Committee stressed that in determining safe levels of mercury exposure, the cumulative level of exposure to all types of mercury must be considered.
Dr. Jeffrey Bradstreet made the following observation at the
July 19, 2002 hearing:
“More concerning to me in the Institute’s treatment of mercury problems, was the almost complete absence of regard for compounding effect of thimerosal on preexisting mercury
levels. The NHANES Study from the CDC had already established that perhaps one in ten children is born to mothers with elevated mercury burden.
The Committee repeatedly heard from government officials that merely exceeding the guideline was not cause for concern. One Merck official, in teaching a Grand Rounds session to staff in November of 1999, postulated that the minimum risk level would need to be multiplied by ten to reach a level at which harm would be expected through exposure. Dr. Roberta McKee of Merck wrote:
“A number of environmental and public health agencies have set a Minimum Risk Level (MRL) for toxic substances. An MRL for ingestion is conceptually equivalent to the Reference Dose of the US Environmental Protection Agency, the Acceptable Daily Intake of the US FDA, and the Tolerable Daily Intake of the WHO. Any exposure to the substance below the MRL is assured to be safe, while exposure to ten times the MRL is assumed to place one at risk of overdose. Exposure at or near the MRL is assumed to be safe but should trigger deliberate and careful review.”
Based on Dr. McKee’s explanation, many babies were exposed to levels of mercury that “placed one at risk of overdose,” and were exposed to amounts well over ten times the EPA’s scientifically validated reference dose. For example, at a recent Committee hearing, Chairman Dan Burton (R-IN) discussed his own family’s experience with vaccine injuries:
“My grandson received vaccines for nine different diseases in one day. He may have been exposed to 62.5 micrograms of mercury in one day through his vaccines. According to his weight, the maximum safe level of mercury he should have been exposed to in one day is 1.5 micrograms, so that is 41 times the amount at which harm can be caused.”
According to the analysis of Dr. McKee, based on the methyl-mercury ingestion guidelines, the Chairman’s grandson would have exceeded the “ten times the MRL” and therefore was placed “at risk of overdose.” In fact, with a 62.5 microgram exposure alone, the EPA, ATSDR, and FDA levels would have been exceeded by 10 times. Because the FDA chose not to recall thimerosal-containing vaccines in 1999, in addition to all of those already injured, 8,000 children a day continued to be placed “at risk for overdose” for at least an additional two years.
It should also be noted that none of the Federal guidelines on mercury exposure have been included specific provisions for safe exposure limits for infants and children. It is widely accepted that infants and young children would be five times more sensitive to the toxic effect of mercury or other neurotoxins than adults. “Exposures early in life are reasonably of greater health concern . . . because of greater brain organ susceptibility.” The FDA has conceded in recent years that many children received doses of ethylmercury through their vaccinations that exceeded the EPA’s minimal risk level for methylmercury.
However, it is also clear that many infants received doses of ethyl-mercury that exceeded the FDA’s higher threshold.
The Trailblazing Patriot 