Connect with us

Alternative News

How The FDA Responds When Asked To Prove That It’s Safe To Inject Mercury (Thimerosal) Into Babies

Published

on

By Lyn Redwood, RN, MSN, Executive Director, World Mercury Project 

advertisement - learn more

Background: Peter Patriarca, an FDA employee, admitted back in 1999, in a confidential e-mail obtained through FOIA, that, “… the greatest point of vulnerability on this issue is that the systematic review of thimerosal in vaccines by the FDA could have been done years ago and on an ongoing basis as the childhood immunization schedule became more complex.  The calculations done by FDA are not complex. I’m not sure if there will be an easy way out of the potential perception that the FDA, CDC and immunization policy bodies may have been “asleep at the switch” re: thimerosal until now”. 

-->Facebook Just Shut Us Down: We need your help in taking our power back from big tech, to overcome censorship and the attack on free speech. Click here to help!

Since 1999, an entire generation of children both in the US and internationally has continued to be exposed to thimerosal – and it is time for this to stop.  Nobody should be exposed to a known neurotoxin.

The Ongoing Saga: On March 30, 2017, Robert F. Kennedy, Jr., and the World Mercury Project (WMP) team met with the Director of the FDA’s Center for Biologics Evaluation and Research (CBER) Dr. Peter Marks, M.D., Ph.D. and his colleagues to discuss the agency’s ongoing refusal to ban thimerosal, a mercury-based preservative, from vaccines in the United States. CBER is the division of the FDA responsible for approving and monitoring the safety of all biological products, including vaccines, allergenic products, blood and blood products, and cellular, tissue, and gene therapies.

At the meeting, we presented a large amount of research showing the toxicity of thimerosal in humans, animals and cellular models, including at levels similar to those resulting from vaccine exposures.  We expressed our alarm regarding the total lack of adequate safety testing of thimerosal prior to licensure, especially given its current use in vaccines approved for infants and pregnant women and its worldwide use in millions of vaccines given to children, particularly in developing countries.  Dr. Marks promised to look over the studies and seriously consider our concerns.

After many months of back and forth emails, Dr. Marks sent a letter to us on July 11th that didn’t even look like he was in the same meeting. World Mercury Project was dismayed by CBER’s apparent unwillingness to seriously review the large archive of published science suggesting that using thimerosal is poisoning a generation of American children.  From his follow-up response, it is clear that none of the information WMP provided was seriously read or even minimally digested.  He made it clear in his letter that CBER does not intend to give any serious consideration to the abundant and mushrooming evidence of thimerosal’s profound toxicity.  His letter was simply an exercise in blindly promoting an incredible vaccine industry orthodoxy that is unsupportable by empirical evidence.

advertisement - learn more

Below is my letter back to Dr. Marks. We are awaiting his response.

Re: Response to your letter regarding the use of mercury in prescription drugs and vaccines.

Dear Dr. Marks,

On March 30th, Robert F. Kennedy Jr. and members of the World Mercury Project met with you and your colleagues at the FDA to discuss our concerns regarding the continued use of the mercury-based preservative, thimerosal, in prescription drugs and influenza vaccines administered to pregnant women, infants and children.

During the meeting and in written letters following the meeting, we voiced concerns regarding:

  • Lack of adequate safety studies prior to marketing thimerosal as a vaccine preservative.
  • Thimerosal’s toxicity and ineffectiveness as a preservative.
  • Mercury exposure from thimerosal-containing vaccine administration resulting in mercury levels known to cause adverse outcomes.
  • Exposure to vaccine-level thimerosal resulting in harmful depositions of inorganic mercury in the brain.
  • The California Environmental Protection Agency’s listing of all mercury-containing products as reproductive and developmental toxicants under their Proposition 65 law.

Thimerosal was removed from all over-the-counter products when the FDA issued final rules in the Federal Register in 1998 acknowledging that thimerosal is not generally recognized as being safe or effective (GRASE).  Why is this same product allowed in prescription drugs and vaccines?

At the end of our meeting, you reassured us that you would take our concerns seriously and would “follow the science” wherever it might lead you. For several months after our meeting, I contacted the FDA public liaison Ms. McNeill inquiring when we might expect to hear back from you regarding our concerns. Ms. McNeill told me that we had provided the agency with extensive information and that it was taking additional time to review the material.  I was hopeful that FDA might finally, therefore, implement the 2001 recommendation of the Institute of Medicine that pregnant women, infants and children not be exposed to thimerosal-containing vaccines.

On July 11th, we received your written response to our concerns. I was dismayed by your agency’s apparent unwillingness to seriously review the large archive of published science suggesting that using thimerosal is poisoning a generation of American children.  From your follow-up written response, it is clear that none of the information we provided was seriously read or even minimally digested.  You make it clear in your letter that you do not intend to give any serious consideration to the abundant and mushrooming evidence of thimerosal’s profound toxicity.  Your letter is simply an exercise in blindly promoting an incredible vaccine industry orthodoxy that is unsupportable by empirical evidence.

You cite in your written response FDA’s mushy biologics regulations which define safety as “the relative freedom from harmful effect to persons affected, directly or indirectly, by a product when prudently administered, taking into consideration the character of the product in relation to the condition of the recipient at the time.” 21CFR 600.39(p). You report that in applying this elastic regulatory standard, “FDA must weigh the risk of a vaccine or any drug against its benefits when determining whether a product is safe. If the benefits of the vaccine or other pharmaceutical product outweigh the risks of its side effects, then the FDA finds the product to be safe.”  You further acknowledge that “the determination of a products safety is a relative rather than absolute measurement”,entirely subject to FDA’s “discretion and expertise.”  Even operating under these malleable standards, FDA should consider that vaccines are products given to healthy individuals, and their risks should be measured by an extremely high bar since they are not treating a disease.  Furthermore, FDA has no capacity to evaluate risks of thimerosal since, by FDA’s own admission to Congress, there has never been a long-term safety study performed on thimerosal in any human population including infants and pregnant women.

Vaccines containing thimerosal in the U.S. are predominantly influenza vaccines.   Furthermore, thimerosal is still widely used in vaccines given to tens of millions of children in the developing world and, since U.S. policy influences worldwide policy, FDA bears responsibility for these policies.  In the U.S., thimerosal-containing vaccines are administered to healthy six-month old infants, young children and pregnant women despite never having been safety tested in those populations.  According to their product inserts, influenza vaccines have been associated with an increased incidence of seizures and Guillain-Barre Syndrome.  Recent studies have linked influenza vaccines to miscarriageautism and, possibly, birth defects.  A significant percentage of influenza vaccines still contain thimerosal and studies should be done to see if thimerosal played a role in these outcomes.   There has been limited testing of influenza vaccines in animal models, however, there have not been any adequate and well-controlled studies in pregnant women. Because animal studies are not always predictive of human response, the package inserts for flu vaccines reiterate that flu vaccines “should be given to a pregnant woman only if clearly needed”. In addition, there are numerous VAERS reports of injuries from thimerosal-containing vaccines.  Therefore, it is imperative that vaccines administered to sensitive populations (pregnant women, infants and children) be held to the highest standards of safety.  I think parents and the American public would be appalled to learn that vaccine safety determinations are “relative” and are within an FDA employee’s “discretion and expertise.”  That discretion and expertise should actually require a factual basis, not just opinion.  Needless to say, these decisions should be guided by the precautionary principle.

I have organized the remainder of my response into addressing the erroneous claims made in your letter.

Your Claim:  The agency evaluates whether a preservative contained in a product is at such levels that when used at the recommended dose is not toxic to the recipient and that the “FDA … has repeatedly found that the vaccines currently being marketed that contain thimerosal are safe…”

WMP Response: Please show us the data used to evaluate thimerosal safety in infants and pregnant women.  We do not believe they exist.

In an email discussion regarding the use of thimerosal-containing influenza vaccines administered to pregnant women, infants and children, in 1999, Dr. William  Egan, acting Director of the Center for Drugs and Biologics (CDER), recommended that the statement, “The chronic, daily ingestion reported (in several studies-primarily Seychelles study) greatly exceeds the amount of mercury that a pregnant woman would receive from a single annual dose of thimerosal-containing influenza vaccine”  might well be deleted.”  Egan went on to justify his recommendation by saying that the statement “…in some ways is misleading.  I am not sure that I would want to argue, for example, that one could take the allowed amount of mercury for a year and administer it as a bolus injection with the same outcome as having it spaced out evenly over the year: the issue then becomes one of how much of a bolus can one give at one time without harmful effect and this data does not exist (or at least I’m not aware of them).”  

Dr. Egan was right then and he is right today; such safety data do not exist.  In fact, many toxicologists believe that large bolus dose exposures such as those resulting from thimerosal-containing vaccines are more harmful in comparison to small daily dose exposures that the body is much more capable of excreting without overburdening detoxification pathways in the body. This concern is supported by research that found a mercury dose given acutely may produce toxic effects, whereas the same dose distributed over a period of time may give no evidence of poisoning. (Koos and Longo,1976).

Your Claim: “Thimerosal has a long record of safe and effective use in preventing bacterial and fungal contamination of vaccines with no ill effects other than occasional hypersensitivity and minor local reactions at the site of injection.”.

WMP Response:  There is ample evidence provided in multiple studies by federal agencies and independent scientists that spans the last 90 years which documents that thimerosal is neither an effective nor a safe vaccine preservative.

In a study published in the Journal of the American Medical Association in 1948 titled “The bacteriostatic and bactericidal actions of some mercurial compounds on hemolytic streptococci,” the authors vigorously argued that thimerosal was ineffective as a “disinfectant, germicide and antiseptic.”  In the review of the literature in this paper, the authors cited eight studies from 1928, 1935, 1937, 1938, and 1944 all of which drew similar conclusions.

In 1975, the FDA convened a panel of experts to evaluate mercury-containing over-the-counter (OTC) products.  The panel issued its reports in 1980 and in 1982.  The FDA issued a report of the panel’s findings in the Federal Register where they concluded that “some mercury-containing preparations are not effective and others are not safe and effective for OTC topical antimicrobial use”.

With respect to thimerosal in particular, that panel found evidence from 1950 which concluded that “thimerosal was no better than water in protecting mice from potential fatal streptococcal infections.” Additionally, citing a 1935 study, the panel reported that thimerosal was “35.3 times more toxic for embryonic chick heart tissue than for Staphylococcus aureus.” Most of the literature reviewed addressed mercury’s lack of antibacterial properties. One review published in 1971 titled, “Three thousand years of mercury. A plea for abandonment of a dangerous, unproven therapy,” addressed mercury’s lack of effectiveness against fungal contamination as well.  

The FDA-appointed expert panel concluded that “thimerosal was not safe for OTC topical use because of its potential for cell damage if applied to broken skin and its allergy potential.  It is not effective as a topical antimicrobial because its bacteriostatic action can be reversed.”  However, it wasn’t until 1998 that the FDA issued its final report banning the use of thimerosal in topical OTC products because it was not “safe and effective.”

There are also several more recent published reports of thimerosal’s failure as a preservative.  Clusters of disease from Group A streptococcus infections were traced back to multi-dose vials of diphtheria toxoid, pertussis, and tetanus toxoid (DPT) vaccine which were contaminated after being opened.  Additionally, in 2004, a Chiron plant that manufactured Fluvirin was forced to close because its vaccine was contaminated with Serratia marcescens.   This vaccine used thimerosal as a preservative. In this case and in the many others cited, thimerosal failed to prevent bacterial growth.

In response to the reports from the FDA expert panel who reviewed the use of thimerosal in over-the-counter products in the 1980’s, the FDA published in the April 22, 1998 Federal Register Status of Certain Additional Over-the-Counter Drug Category II and III Active Ingredients. (April 22, 1998);63(77):19799-19802. 21 CFR Part 310 [Docket No. 75N-183F, 75N-183D, and 80N-0280 concluding that the use of thimerosal in over the counter products is not “generally recognized as safe or effective” (GRASE).

In the final rulemaking, the FDA states that “safety and effectiveness have not been established for the ingredients (mercury-based preservatives) included in this current final rule and manufacturers have not submitted the necessary data in response to earlier opportunities. The agency’s experience has been that under these circumstances companies have not submitted data in response to yet another opportunity. Consumers will benefit from the early removal from the marketplace of products containing ingredients for which safety and effectiveness has not been established.”

The World Mercury Project would like to know how is it possible that one division of the FDA recognizes that there is absolutely no safety or effectiveness data available for the use of mercury in over the counter products and essentially bans its use, while your FDA division of blood and biologics continues to recklessly allow its widespread use in over 100 prescription products including vaccines?

Your claim: “Under the FDA Modernization Act (FDAMA) of 1997, the FDA conducted a comprehensive review of the use of thimerosal in childhood vaccines.  Conducted in 1999, this review found no evidence of harm from the use of thimerosal as a vaccine preservative, other than local hypersensitivity reactions (Ball et al. 2001).”

WMP Response:  It’s disturbing that according to internal emails obtained by FOIA, Dr. Ball never conducted an extensive review of reports of harm.  On November 23, 1998, Dr. Leslie Ball of the FDA asked internal reviewers to perform a Medwatch query on thimerosal.  Medwatch is the FDA’s database for reporting adverse drug events.   On January 7, 1999, Dr. Ball was informed by Fredrick Varricchio of FDA that there were 7000 reports containing the word thimerosal on FDA’s Medwatch.  He stated, “I have some results for you.  Problem is that there are 7000 reports that mention thimerosal. What to do now.  Obviously looking at all 7,000 is a brute force approach.”  Dr. Ball responded by saying, “perhaps you can get records on a subset of 50 or so we can look at them and get a general feel for what’s been reported before we go any further.”  In a subsequent email on January 19th, Mr. Varricchio noted that the “plan is to get whatever is on the summary for every 100th report.” This means that only 70 adverse events out of 7000 reported to the FDA were actually reviewed by Dr. Ball and her team. This email calls into question the findings reported by Dr. Ball and also suggests that an extensive investigation has never been conducted by the FDA with regard to adverse events associated with the use of thimerosal.  Would you allow any other medical product to be widely used based on review of one percent of the information available?

I am also, Sir, frankly shocked at your unwillingness to acknowledge the robust body of literature that has been published the last 18 years since concerns regarding thimerosal first surfaced within the FDA in 1999.

There are literally hundreds of peer-reviewed, published studies that document the toxicity of thimerosal. Many of these investigated levels of mercury known to occur from vaccine exposure in cell and animal models.  In 2013, Jose G. Dorea published a meta-analysis of thimerosal research related to vaccine exposure.  Dorea searched major databases for human and experimental studies that addressed issues related to early life exposure to TCVs. The author concluded that: “ a) mercury load in fetuses, neonates, and infants resulting from TCVs remains in blood of neonates and infants at sufficient concentration and for enough time to penetrate the brain and to exert a neurologic impact and a probable influence on neurodevelopment of susceptible infants; b) etHg metabolism related to neurodevelopmental delays has been demonstrated experimentally and observed in population studies; c) unlike chronic Hg exposure during pregnancy, neurodevelopmental effects caused by acute (repeated/cumulative) early life exposure to TCV-etHg remain unrecognized; and d) the uncertainty surrounding low-dose toxicity of etHg is challenging but recent evidence indicates that avoiding cumulative insults by alkyl-mercury forms (which include Thimerosal) is warranted.”  Dorea emphasized the importance of “a) maintaining trust in vaccines while reinforcing current public health policies to abate mercury exposure in infancy; b) supporting WHO policies that recommend vaccination to prevent and control existing and impending infectious diseases; and c) not confusing the ‘need’ to use a specific ‘product’ (TCV) by accepting as ‘innocuous’ (or without consequences) the presence of a proven ‘toxic alkyl-mercury’ (etHg) at levels that have not been proven to be toxicologically safe.”

For your convenience, I have included a sampling of 35 abstracts that represent the more current state of the science regarding thimerosal that has emerged since 1999 as an appendix.  Even if Dr. Ball’s review had been adequate at that time, surely 18 years of further research should prompt an updated evaluation by the FDA.

Your Claim: A 2014 modeling study by your own Centers for Biologics Evaluation and Research employee, Dr. Robert Mitkus, showed that “peak body burdens of mercury following episodic exposures to thimerosal in this worst case did not exceed the corresponding safe body burden of mercury from MeHg at any time”.

WMP Response:  The Mitkus study reported that the body burden of mercury in infants, over the first 4.5 years of life following yearly exposures to thimerosal from annual flu vaccines, was two orders of magnitude lower than that estimated for exposures to the lowest regulatory threshold for MeHg over the same time period. The author relies completely on these findings to conclude that their pharmacokinetic analysis supports the safety of thimerosal when used as a preservative at current levels in certain multi-dose infant vaccines in the United States. Mitkus fails to acknowledge the past levels of exposure that infants received from vaccines starting in the late 1980s and extending well into 2000, that were 187.5 mcg etHg the first year of life versus 12.5 mcg etHg from flu vaccines annually. He also makes the assumption that there are no other mercury exposures outside of thimerosal, which is not supported by either established science or common sense.

The model developed by Mitkus relied solely on blood levels and did not take into consideration the accumulation of mercury in the brain tissue.  Data from the Burbacherstudy that assessed exposures from both methyl and ethyl mercury in infant non-human primates, based on vaccine level exposures, found that although there was little accumulation of Hg in the blood with repeated vaccinations, accumulation of Hg in the brain of infants did occur. In fact, there was a much higher proportion of inorganic Hg in the brain of thimerosal monkeys than in the brains of MeHg monkeys (up to 71% vs. 10%). Absolute inorganic Hg concentrations in the brains of the thimerosal-exposed monkeys were approximately twice that of the MeHg monkeys. Burbacher concluded that “the safety of thimerosal drawn from blood Hg clearance data in human infants receiving vaccines may not be valid, given the significantly slower half-life of Hg in the brain as observed in the infant macaques.”  But that is exactly what Mitkus does in his model and reports in his study.

Mitkus also makes the statement that thimerosal is more quickly and extensively metabolized to inorganic mercury in the brain than is MeHg and that process of dealkylation “may be” a detoxification step.  According to Burbacher, who is the author of the studies relied on by Mitkus in the development of his model, the statement that dealkylation may be a detoxification process is purely speculative and has not been established.  Mitkus is referring to previous reports that have indicated that dealkylation of Hg is a detoxification process that helps to protect the central nervous system (Magos 2003Magos et al. 1985). These reports are largely based on histology and histochemistry studies of adult rodents exposed to Hg for a short period of time. The results of these studies indicated that damage to the cerebellum was observed only in MeHg-treated animals that had much lower levels of inorganic Hg in the brain than animals comparably treated with ethylmercury. Moreover, the results did not indicate the presence of inorganic Hg deposits in the area where the cerebellar damage was localized (granular layer). In contrast, previous studies of adult M. fascicularis monkeys exposed chronically to MeHg have indicated that demethylation of Hg occurs in the brain over a long period of time after MeHg exposure and that this is not a detoxification process (Charleston et al. 199419951996Vahter et al. 19941995). Results from these studies indicated higher inorganic Hg concentrations in the brain 6 months after MeHg exposure had ended, whereas organic Hg had cleared from the brain. The estimated half-life of organic Hg in the brain of these adult monkeys was consistent across various brain regions at approximately 37 days (similar to the brain half-life in the Burbacher study). Stereologic and autometallographic studies on the brains of these adult monkeys indicated that the persistence of inorganic Hg in the brain was associated with a significant increase in the number of microglia in the brain. (Charleston et al. 19941995,1996). The microgliosis and neuroinflamation documented in the brains of the adult monkeys in association with deposits of inorganic mercury are two hallmark findings in brain tissue of both children and adults with autism.  Neuropathological studies of brain tissues from cerebellum, midfrontal, and cingulate gyrus obtained at autopsy from 11 patients with autism demonstrated the presence of an active neuroinflammatory processes in the cerebral cortex, white matter and, most notably, the cerebellum.  In a subsequent study, microglia appeared markedly activated in five of 13 cases with autism, including two of three under age six, and marginally activated in an additional four of 13 cases. The authors concluded that microglial activation “represents a neuropathological alteration in a sizeable fraction of cases with autism. Given its early presence, microglial activation may play a central role in the pathogenesis of autism in a substantial proportion of patients.”

In responding to the Mitkus study, I also need to refer back to previous meetings with FDA CBER employees. When FDA assigned its pediatrician, Dr. Leslie Ball, to oversee the review, analysis and public reporting of thimerosal, Dr. Ball had little knowledge of toxicology or thimerosal.  In 1999, Dr. Ball and her colleagues conducted an analysis that was prompted by the Food and Drug Modernization Act of 1997 which required FDA to compile a list of drugs and food that contain “intentionally” introduced mercury compounds and provide a qualitative and quantitative analysis of the exposure levels. They reported that the limits of exposure to mercury for an infant in the first year of life should be between 200-230 mcg total.  Infants are exposed to approximately 80 to 100 mcg of organic mercury from environmental sources alone.  Therefore, additional exposures from thimerosal-containing vaccines should be below 120 to 130 mcg the first year of life according to the FDA’s own findings.  At the time this analysis was done, American children were routinely receiving 187.5 mcg of organic mercury during the first year of life from vaccines.  This means American children were being exposed to cumulative levels of organic mercury in excess of federal safety guidelines.

The FDA consulted with an expert in the field of toxicology, Dr. Barry Rumack, MD, to better understand the potential impact of these exposure levels.  Dr. Rumack had a private consulting practice where he offered “toxicologic and pharmacologic evaluation of drugs, biological and potentially toxic or hazardous agents for government and industry”.  After creating several scenarios based on infants’ ages and weights, Dr. Rumack modeled both blood and body burden levels.

The models predicted sharp peaks of mercury concentrations in both blood and tissue, in a stair step sequence following each of the new thimerosal-containing vaccines given during the first six months of life.  Based on these models, Rumack predicted exposure to thimerosal-containing vaccines was dosing American children with mercury levels far exceeding all three federal safety guidelines established by EPA, FDA and ATSDR.  There was no point in time from birth to approximately 16-18 months of age that infants were below the EPA guidelines for allowable mercury exposure.  In fact, according to the models, blood and body burden levels of mercury peaked at six months of age at a shockingly high level of 120 ng/liter. To put this in perspective, the CDC classifies mercury poisoning as blood levels of mercury greater than 10 ng/liter.  What is even more concerning is that the models developed by Dr. Rumack did not take into account background exposures from environmental and dietary sources of mercury.

In reporting the mercury exposure levels that result from thimerosal containing vaccines, the FDA chose not to report the findings from Rumack and Ball.  Instead, they averaged the exposures over the first six months of life, even though the exposures only occurred at birth, two, four, and six months of age or during four days out of 180 days.  In doing so, the agency could report that the exposures were below FDA and ATSDR guidelines in an effort to minimize concern.

In discussing this with independent toxicologists, I have been told that averaging exposures is not appropriate due to the fact that large bolus dose exposures are known to be more injurious than small daily dose exposures. If the FDA had reported the exposure levels from a daily dose perspective, it would reveal that infants were being exposed to mercury far in excess of ALL federal safety guidelines: FDA, ATSDR and EPA.

For example, my son at two months of age weighed 5 kg and received 62.5mcg Et Hg from his vaccines.  According to the EPA methyl mercury guidelines of .1 mcg per kg per day, his maximum exposure level for that one day was 0.5 mcg of mercury.  He received 125 times his daily allowable exposure level or 125 days of his daily allowable exposure. An analogy would be that it would be allowable to give my infant son a ½ tsp of Tylenol four times a day (320 mg), but if I gave him a 30-day dose of Tylenol (9,600 mg) on one day, it would be lethal. When I personally asked Dr. Ball why she reported the mercury exposure levels in this deceptive fashion, she responded, “That is what I was told to do.”

In a subsequent email to her superiors at FDA on July 6th, 1999 (six months after she had started her review of thimerosal), marked as being highly important and confidential and obtained through a Freedom of Information Act request, Dr. Ball asked Norman Baylor, PH D, Director of the Office of Vaccines Research Review, “Has the application of these calculations as exposure guidelines received the sign off by toxicologists?  In prior discussions, the toxicologists seemed reluctant to state any Hg (mercury) level was “safe”.” Although there was no response back from Dr. Baylor in the FOIA documents we received, it is obvious that the answer was no.

By 2000, there was already a mountain of evidence that thimerosal was unsafe and ineffective.  For example, in 1987 the Commission of the European Communities initiated a research project on 10 known or suspected spindle poisons including thimerosal. In 1993, as described in Mutation Research, 287 (1993) 17-22 thimerosal was identified as a strong inhibitor of microtubular assembly, a process which is essential for proper neuronal development.  In 2000, Stajich et al.  measured blood Hg levels in newborns administered the Hepatitis B vaccine, containing 12.5 mcg ethyl mercury, and found elevated post-immunization concentrations relative to pre-immunization levels in all neonates studied.  Levels of blood mercury after exposure in low birth weight infants were 7.36 mcg/L (± 4.99).  One infant was found to have mercury levels of 23.6 mcg/L after exposure, which supports the inter-individual variability of mercury intoxication.  The study subjects had measurable blood Hg concentrations prior to immunization, indicating that risk assessment must include background mercury levels from other sources.

I also find it disturbing that safety assessments you reference take the position that thimerosal is a necessary ingredient for influenza vaccines.  This, of course, is not true.  Influenza manufacturers presently make approximately two-thirds of the U.S. influenza vaccine supply without the use of thimerosal by placing the vaccine in a single dose vial or syringe, which completely eliminates the need for a preservative.

Your Claim:   The scientific evidence collected over the past 15 years does not show any evidence of harm, including serious neurodevelopmental disorders from the use of thimerosal in vaccines. The Institute of Medicine report from 2004 concluded that the evidence favors rejection of a link between thimerosal and autism based on several epidemiological studies.

WMP Response:  A causal relationship between autism and vaccinations cannot be proven or rejected based on evidence from population-based epidemiologic studies – period. Epidemiological studies, by definition, are not designed to prove causality; they can provide only statistical associations.  Therefore, the committee’s conclusion that the “body of epidemiologic evidence favors rejection of a causal relationship…” has no scientific meaning.

Further, in the IOM report the committee admitted that population-based studies would not be able to detect subpopulations that could be genetically more vulnerable to mercury at lower doses than typical. On page 139, the report states that “This hypothesis cannot be excluded by epidemiological data from large population groups that do not show an association between a vaccine and an adverse outcome.  Depending upon the frequency of the genetic defect, a rare event caused by genetic susceptibility could be missed even in large study samples.”

What you also failed to acknowledge is that several of the same epidemiological studies reviewed by the IOM in 2004 documented an association between thimerosal-containing vaccine exposures during infancy and the subsequent development of motor and phonic tics.  Tics are a family of neurological disorders that are also associated with a diagnosis of autism. A significant association between Hg exposure from thimerosal-containing childhood vaccines and a diagnosis of tic disorder (TD) has now been found in six epidemiological studies (Verstraeten et al. 2003Andrews et al. 2004Thompson et al. 2007Young et al, 2008Barile et al. 2012Geier et al. 2015).   The Thompson study states that, “The replication of the findings regarding tics suggests the potential need for further studies.”  Tozzi et al. 2009, also found trends towards increased motor and phonic tics with increased thimerosal exposure but these did not reach statistical significance, possibly because of the lack of a non-exposed control group. These studies employed various epidemiological methods such as case–control or cohort designs, and were conducted on cohorts of children from several different countries. In addition, several of these studies observed significant dose-dependent relationships between Hg exposure from thimerosal in vaccines and the risk of diagnosed TD. A study by Young et al. found a dose-dependent relationship between increasing Hg exposure from thimerosal in vaccines given between birth and seven months and also between birth and 13 months of age and the risk of a diagnosed TD. Researchers observed that, for a 100 μg Hg difference in exposure between birth and seven months of age, the risk for diagnosed TD was significantly increased (3.39-fold). For the same 100 μg Hg difference in exposure between birth and 13 months of age, the risk for diagnosed tics was also found to be significantly increased (4.11-fold).

Autism etiology and severity have also been associated with mercury levels.  In June of this year, the international journal Science of the Total Environment published a compelling study from the Republic of Korea. The study identifies a strong relationship between prenatal and early childhood exposure to mercury and autistic behaviors in five-year-olds.  The  MOCEH study examines environmental exposures during pregnancy and childhood and their effects on children’s growth and development. A unique feature is that it includes five different blood samples: maternal blood from early and late pregnancy; cord blood; and samples from children at two and three years of age. In addition, the study asks mothers to complete three follow-up surveys and—when their child reaches age five—the 65-item Social Responsiveness Scale (SRS), which assesses autistic behaviors.

The investigators report a significant linear relationship between mercury exposure and autistic behaviors (as indicated by a scaled score called an SRS T-score). Strikingly, they find that with a doubling of blood mercury levels at four time points (late pregnancy, cord blood, and at two and three years of age), SRS T-scores are significantly higher. They also looked specifically at SRS T-scores greater than or equal to 60. Sixty and above is the accepted threshold for detecting “mild to moderate” deficits of social behavior related to autism; scores of 76 or more are in the “severe” range. In these analyses, the same linear relationship holds for late pregnancy and birth (i.e., cord blood). With a doubling of blood mercury levels at these two time points, there is a 31% and 28% increase, respectively, in the risk of an SRS T-score of 60 or more. Finally, the researchers identify a stronger association between late-pregnancy mercury exposure and autistic behaviors in five-year-old boys versus five-year-old girls, perhaps due to mercury’s endocrine-disrupting properties.

Your Claim:  Schechter and Grether, 2008, showed that California’s rates of autism continued to rise while thimerosal was being phased out from three of the early childhood vaccines.

WMP Response:  This study has significant limitations in addressing what was really going on in the time period from 1999 to 2003.  Schechter and Grether estimated exposure for each birth cohort but made no attempt to look at the actual thimerosal exposures of individual children relative to their diagnosis.  In fact, looking at the data for the CDDS for the years immediately following their study, there was a notable flattening of the autism prevalence growth curve in the 2004-2006 birth cohorts, suggesting a possible effect of thimerosal phase-out.  At the same time, however, any downward effect on autism rates would have been blunted by three national autism awareness campaigns, by Autism Speaks, the CDC and the AAP , starting early in 2005 and continuing into 2006 which raised public awareness dramatically.

While thimerosal was being phased out of the Hepatitis B, Hib and DTaP vaccines over those four years, thimerosal exposure through influenza vaccines was increasing.  In 2004, the CDC started recommending flu shots for pregnant women in any trimester.  In 2004, over 90% of the supply of influenza vaccines contained thimerosal.  Studies of methyl mercury show that mercury is typically 1.7 times higher in cord blood than in maternal blood and there are no studies investigating the pharmacokinetics of ethylmercury in pregnancy.  Concurrently, in January 2003, the CDC recommended flu shots with thimerosal for all children starting at six months of age.  The idea that children were no longer being exposed to thimerosal was and is a fallacy.

Beyond California, in the spring of 2016, the CDC’s ADDM network finally reported the autism prevalence of children born in 2004.  For the first time that data did not show an increase in autism prevalence compared to the 2002 birth year cohort.  They both had a one in 68 prevalence.  This suggests that the removal of thimerosal from the three pediatric vaccines may have flattened autism rates prior to the widespread uptake of the flu vaccine and increased awareness. That same paper, based on children born in 2004, reported a prevalence of Autism Spectrum Disorders with IQ<70 of 4.0 per 1000.  This was a 15% drop from the previous report based on children born in 2002, when the prevalence of ASDs with IQ<70 was 4.7 per 1000.  Note that this had nothing to do with percentages of the ASD population or additional higher-functioning children being diagnosed – this meant that there were actually fewer severely affected children on a population basis.

Finally, your focus on autism ignores the evidence of thimerosal’s associations with a range of other disorders including ADHD, speech disorders, seizure disorders, autoimmunity and eczema and the broader associations of mercury with auditory and speech impairment, nephrotoxicity and somatosensory disorders.  According to the CDC, one in six American children of the thimerosal generation now suffers from a neurodevelopmental disorder. An HHS funded study found that 54% of children have a chronic disease.  What evidence have you, if any, that thimerosal is not a major culprit in the epidemics that have devastated this generation?  “None” is the answer!

Dr. Marks, I perceive you to be a smart man and sincere in your desire to protect children from harm. Do you, as an individual, not as the Director of CBER, really believe that the continued use of thimerosal in products given to pregnant women, infants and children, when it is completely unnecessary, is appropriate? I’m appealing to you as the mother of a young man who will never be able to take advantage of his full potential because he was harmed by thimerosal and other sources of mercury. It is my life’s mission, much like the mother who started MADD, to protect all children from this completely unnecessary exposure to mercury. I ask that you please again take our concerns to heart and help support our efforts instead of regurgitating the inaccurate and indefensible positions of your agency.

Sincerely,

Lyn Redwood RN, MSN, Executive Director

World Mercury Project

Read our overview — background and all of the letters between FDA and World Mercury Project.

Sign up for free news and updates from Robert F. Kennedy, Jr. and the World Mercury Project. Your donation will help to support us in our efforts.

Become Part of CE's Inner Circle

Collective Evolution is one of the world's fastest-growing conscious media and education companies providing news and tools to raise collective consciousness. Get inside access to Collective Evolution by becoming a member of CETV.

Stream content 24/7 and enjoy mind-expanding interviews, original shows, documentaries and guided programs.

Click here to start a FREE 7-Day Trial and help conscious media thrive!

Advertisement
advertisement - learn more

Alternative News

Vancouver Council Votes Against Mandatory Mask Mandate: They’re Not Required

Published

on

In Brief

  • The Facts:

    Vancouver, Canada will not have a required mask policy in civic facilities, and instead will simply recommend that people wear them.

  • Reflect On:

    Should governments recommend what they feel we should do and present the science instead of forcing certain measures on the population that many people and health professionals clearly disagree with?

What Happened: The city of Vancouver, British Columbia, Canada will not mandate masks inside city buildings and will “strongly encourage” people to wear them instead. This is a bold move as many cities across the globe have mandatory mask measures in place.

The proposal by Counc. Sarah Kirby-Yung, which would have required masks inside city buildings, was opposed by more than a dozen speakers who pleaded with the city council to vote against it.

“Please consider our forefathers fought for our freedom, and if we release that choice, it’s the first step towards a dictatorship,” said one speaker according to City News. “Masks are used as weapons and they have certainly been used as weapons against me and others to silence and marginalize us and it’s not fair.”

According to Coun. Christine Boyle, public health experts encourage wearing masks, but a mandatory policy is not needed.

Become Part of CE's Inner Circle

Collective Evolution is one of the world's fastest-growing conscious media and education companies providing news and tools to raise collective consciousness. Get inside access to Collective Evolution by becoming a member of CETV.

Stream content 24/7 and enjoy mind-expanding interviews, original shows, documentaries and guided programs.

Click here to start a FREE 7-Day Trial and help conscious media thrive!

Continue Reading

Alternative News

Positive Association Found Amongst COVID Deaths & Flu Shot Rates Worldwide In Elderly

Published

on

In Brief

  • The Facts:

    A recently published paper has found a positive association between COVID-19 deaths and influenza vaccination rates in elderly people worldwide.

  • Reflect On:

    Why does vaccine hesitancy continue to grow worldwide? What's going on? What information/factors are contributing to this hesitancy?

What Happened: A recently published study in PeerJ  by Christian Wehenkel, a Professor at Universidad Juárez del Estado de Durango in Mexico, has found a positive association between COVID-19 deaths and influenza vaccination rates in elderly people worldwide.

According to the study, “The results showed a positive association between COVID-19 deaths and IVR (influenza vaccination rate) of people ≥65 years-old. There is a significant increase in COVID-19 deaths from eastern to western regions in the world. Further exploration is needed to explain these findings, and additional work on this line of research may lead to prevention of deaths associated with COVID-19.”

To determine this association, data sets from 39 countries with more than half a million people were analyzed.

The study was published on October 1st, and two weeks later a note from the publisher appeared atop the paper emphasizing that correlation does not equal causation, and that this paper “should not be taken to suggest that receiving the influenza vaccination results in an increased risk of death for an individual with COVID-19 as there may be confounding factors at play.”

The paper provides evidence from others which have recently been published that ponder if the flu shot could increase ones chance of contracting and dying from COVID-19.

For example, this study published in April of 2020, reported a negative correlation between influenza vaccination rates (IVRs) and COVID-19 related mortality and morbidity. Marín-Hernández, Schwartz & Nixon (2020) also showed epidemiological evidence of an association between higher influenza vaccine uptake by elderly people and lower percentage of COVID-19 deaths in Italy, which directly contradicts the author’s own findings and suggests that the flu shot may help prevent COVID-19 related deaths.

He goes on to mention another study:

In a study analyzing 92,664 clinically and molecularly confirmed COVID-19 cases in Brazil, Fink et al. (2020) reported that patients who received a recent flu vaccine experienced on average 17% lower odds of death. Moreover, Pawlowski et al. (2020) analyzed the immunization records of 137,037 individuals who tested positive in a SARS-CoV-2 PCR. They found that polio, Hemophilus influenzae type-B, measles-mumps-rubella, varicella, pneumococcal conjugate (PCV13), geriatric flu, and hepatitis A/hepatitis B (HepA-HepB) vaccines, which had been administered in the past 1, 2, and 5 years, were associated with decreased SARS-CoV-2 infection rates.

So, its important to mention that correlations between the flu vaccine have also found that it may decrease ones chance of deaths from COVID-19.

But are there studies that have shown an increased chance of death or contracting other respiratory viruses as a result of getting the flu shot? Yes.

That’s also discussed in the paper. For example, he mentions a paper published in 2018:

In a study with 6,120 subjects, Wolff (2020) reported that influenza vaccination was significantly associated with a higher risk of some other respiratory diseases, due to virus interference. In a specific examination of non-influenza viruses, the odds of coronavirus infection (but not the COVID-19 virus) in vaccinated individuals were significantly higher, when compared to unvaccinated individuals (odds ratio = 1.36).

The study above found the flu shot to increase the risk of other coronaviruses among those who had been vaccinated for influenza by 36 percent. The study was conducted prior to COVID-19, so it’s not included and only applies to pre-existing coronaviruses. The study also found an even higher chance of contracting human metapneumovirus amongst those who had received the flu shot.

Below are some more studies regarding the flu shot and viral infections that hint to the same idea.

  • 2018 CDC study (Rikin et al 2018) found that flu shots increase the risk of non-flu acute respiratory illnesses (ARIs), including coronavirus, in children.
  • A 2011 Australian study (Kelly et al 2011) found that flu shots doubled the risk for non-flu viral lung infections.
  • 2012 Hong Kong study (Cowling et al 2012) found that flu shots increase the risk for non-flu respiratory infections by 4.4 times.
  • 2017 study (Mawson et al 2017) found vaccinated children were 5.9 times more likely to suffer pneumonia than their unvaccinated peers.

Why This Is Important: We live in an age where vaccinations are heavily marketed. We’ve seen this with the flu shot time and time again and we are also living in an age where a push for more mandated vaccines seems to be growing.

Dr. Peter Doshi is an associate editor at The BMJ (British Medical Journal) and also an assistant professor of pharmaceutical health services research at the University of Maryland School of Pharmacy. He published a paper in The BMJ titled “Influenza: Marketing Vaccines By Marketing Disease.”  In it,  he points out that the CDC pledges “to base all public health decisions on the highest quality of scientific data, openly and objectively derived,” and how this isn’t the case when it comes to the flu vaccine and its marketing. He stresses that “the vaccine may be less beneficial and less safe than has been claimed, and that “the threat of influenza seems to be overstated.”

This is a touchy subject that dives into medical ethics and the connections that big pharmaceutical companies have with our federal health regulatory agencies and health associations. Vaccines are a multi billion dollar industry.

At a recent World Health Organization conference on vaccine safety, it was expressed that vaccine hesitancy is growing at quite a fast pace, especially among doctors who are now becoming hesitant to recommend certain vaccines on the schedule. You can read more about that and find links to the conference here.

We have to ask ourselves, why is this happening? Is it because people and professionals are becoming aware of certain information that warrants the freedom of choice? Should freedom of choice with regards to what we put in our body always remain? Are we really protecting the “herd” by taking these actions?

In a 2014 analysis in the Oregon Law Review by New York University (NYU) legal scholars Mary Holland and Chase E. Zachary (who also has a Princeton-conferred doctorate in chemistry), the authors show that 60 years of compulsory vaccine policies “have not attained herd immunity for any childhood disease.” It is time, they suggest, to cast aside coercion in favor of voluntary choice.

When it comes to the flu shot, I put more information and science as to why so many people seem to refuse it, in this article if interested.

The University of California is currently being sued for mandating the flu shot for all staff, faculty and students. A judge has prevented them from doing so as a result until a decision has been made. You can read more about that here.

In South Korea, 48 people have now died after receiving the flu shot this season causing a lot of controversy. You can read more about that here.

The Takeaway: There are many concerns with vaccines, and vaccine injury is one of them. The National Childhood Vaccine Injury Act has paid more than $4 billion to families of vaccine injured children. A 2010 HHS pilot study by the Federal Agency for Health Care Research (AHCR) found that 1 in every 39 vaccines causes injury, a shocking comparison to the claims from the CDC of 1 in every million.

Should these statistics alone warrant the freedom of choice? Should the government have the ability to force us into measures, or would it simply be better for them to present the science, make recommendations and urge people to follow them? When the citizenry is forced and coerced into certain actions, sometimes under the guise of good-will, there always seems to be a tremendous amount of uproar and people who disagree. Why are these people silenced? Why are they censored? Why are they ridiculed? Why don’t independent health organizations receive the same voice and reach that government and state “owned” or organizations do? What’s going on here? Do we really live in a free, open and transparent world or are we simply subjected to massive amounts of perception manipulation?

When it come to the flu shot there is plenty of information on both sides of the coin that point to its effectiveness, and on the other hand there is information that points to the complete opposite. When something is not 100 percent clear, freedom of choice in all places should always remain, in my opinion.

Become Part of CE's Inner Circle

Collective Evolution is one of the world's fastest-growing conscious media and education companies providing news and tools to raise collective consciousness. Get inside access to Collective Evolution by becoming a member of CETV.

Stream content 24/7 and enjoy mind-expanding interviews, original shows, documentaries and guided programs.

Click here to start a FREE 7-Day Trial and help conscious media thrive!

Continue Reading

Alternative News

Some South Korean Doctors & Politicians Call To Stop Flu Shots After 48 People Die

Published

on

In Brief

  • The Facts:

    The number of South Koreans who have died after getting flu shots has risen to 48, but health authorities in South Korea have found no link between the vaccine and the deaths.

  • Reflect On:

    Is the flu shot as safe as it's marketed to be?

What Happened: It’s that time of year and flu shot programs are rolling out across the globe. The number of South Koreans who have died after getting the flu shot has now risen to 48 and some South Korean doctors and politicians have called to stop flu shots as a result, according to Reuters. The Korea Disease Control and Prevention Agency (KDCA) has decided not to stop the program, and that flu vaccines would continue to be given and will reduce the chance of having simultaneous epidemics in the era of COVID-19.

Health authorities in South Korea have explained that they’ve found no direct link between these deaths and the shots. KDCA Director Jeong Eun-kyung said, “After reviewing death cases so far, it is not the time to suspend a flu vaccination programme since vaccination is very crucial this year, considering…the COVID-19 outbreaks.”

According to Reuters, “Some initial autopsy results from the police and the National Forensic Service showed that 13 people died of cardiovascular, cerebrovascular and other disorders not caused by the vaccination.”

The South Korean government is hopeful to vaccinate approximately 30 million of the country’s 54 million people.

Concerns Some People Have With The Flu Shot: One concern many people seem to have is the worry of a severe adverse reaction.

Dr. Alvin Moss, MD and professor at the West Virginia University School of Medicine emphasizes in this video:

The flu vaccine happens to be the vaccine that causes the most injury in this country. The vaccine injury compensation program, 40 percent of all vaccinations in this country are flu shots, but 60 percent of all the compensations are for the flu vaccine. So a disproportionate number of  vaccine related injuries are the flu shot.

Moss is one of many who believe that the flu vaccine is not as effective as it’s been marketed to be. For example,  A study recently published in Global Advances In Health & Medicine titled “Ascorbate as Prophylaxis and Therapy for COVID-19—Update From Shanghai and U.S. Medical Institutions outlines the following:

Recently outlined A recent consensus statement from a group of renowned infectious disease clinicians observed that vaccine programs have proven ill-suited to the fast-changing viruses underlying these illnesses, with efficacy ranging from 19% to 54% in the past few years.

Dr. Peter Doshi is an associate editor at The BMJ (British Medical Journal)  published a paper in The BMJ titled “Influenza: Marketing Vaccines By Marketing Disease.”  In it,  he points out that the CDC pledges “to base all public health decisions on the highest quality of scientific data, openly and objectively derived,” and how this isn’t the case when it comes to the flu vaccine and its marketing. He stresses that “the vaccine may be less beneficial and less safe than has been claimed, and that “the threat of influenza seems to be overstated.”

These are just a few examples out of many claiming that the flu shot has not really been effective, opposing others that claim it is.  Mercury that’s still present in some flu shots also seems to be a concern.

The National Childhood Vaccine Injury Act has paid more than $4 billion to families of vaccine injured children. A 2010 HHS pilot study by the Federal Agency for Health Care Research (AHCR) found that 1 in every 39 vaccines causes injury, a shocking comparison to the claims from the CDC of 1 in every million.

Professor Heidi Larson, a Professor of Anthropology and the Risk and Decision Scientist Director at the Vaccine Confidence Project stated at a World Health Organization (WHO) conference that more doctors are starting to be hesitant when it comes to recommending vaccines.

The other thing that’s a trend, and an issue, is not just confidence in providers but confidence of health care providers, we have a very wobbly health professional frontline that is starting to question vaccines and the safety of vaccines. That’s a huge problem, because to this day any study I’ve seen… still, the most trusted person on any study I’ve seen globally is the health care provider…

This is no secret, and actions against mandates are being taken. The University of California was recently sued for making the flu shot mandatory. That trial will begin soon, and you can read more about it here, and find information regarding the claim that the flu shot can help in the times of COVID-19.

The Takeaway: We are living in an age of extreme censorship of information, no matter how credible or how much evidence is provided, information that goes against the grain always seems to receive a harsh backlash from mainstream media as well as social media outlets. Why is there a digital fact checker patrolling the internet? Should people not have the right to examine information openly and freely and determine for themselves what is and what isn’t?

As far as vaccines are concerned, despite the fact that there are many safety issues the scientific community  is bringing up, a push for vaccine mandates continues and the idea that we are protecting other people is usually the narrative that’s pushed hard. Vaccine skepticism is growing at a fast pace among people of all professions, and people aren’t stupid. There’s a reason why more and more people are starting to question what we’ve been told for years, and those reasons should be acknowledged and openly discussed amongst people on both sides of the coin.

Become Part of CE's Inner Circle

Collective Evolution is one of the world's fastest-growing conscious media and education companies providing news and tools to raise collective consciousness. Get inside access to Collective Evolution by becoming a member of CETV.

Stream content 24/7 and enjoy mind-expanding interviews, original shows, documentaries and guided programs.

Click here to start a FREE 7-Day Trial and help conscious media thrive!

Continue Reading
advertisement - learn more
advertisement - learn more

Video

Elevate your inbox and get conscious articles sent directly to your inbox!

Choose your topics of interest below:

You have Successfully Subscribed!