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California is the first U.S. state to require Monsanto to label its blockbuster weed killer, Roundup, as a possible carcinogen, according to a ruling issued Friday by a California judge.

Fresno County Superior Court Judge Kristi Kapetan previously issued a tentative ruling on Jan. 27 in Monsanto Company v. Office of Environmental Health Hazard Assessment, et al.

Judge Kapetan formalized her ruling Friday against Monsanto, which will allow California to proceed with the process of listing glyphosate, the active ingredient in Roundup, as a chemical "known to the state to cause cancer" in accordance with the Safe Drinking Water and Toxic Enforcement Act of 1986, better known as Proposition 65.

In January of 2016, Monsanto filed a lawsuit against the State of California Environmental Protection Agency's Office of Environmental Health Hazard Assessment (OEHHA) over the agency's notice of intent to list glyphosate as a Prop 65 chemical.

OEHHA issued the notice after the World Health Organization's International Agency for Research on Cancer (IARC) issued a report on glyphosate, which classified the chemical as a "probable human carcinogen." The IARC report compelled OEHHA to list glyphosate as a Prop 65 chemical and warn consumers about the possible danger associated with glyphosate exposure.

Why Did Monsanto Sue the State of California?

In 1986, California voters approved Proposition 65 to address concerns about exposure to toxic chemicals. Prop 65 requires California to publish a list of chemicals known to cause cancer, birth defects or other reproductive harm.

OEHHA is the administrator for the Proposition 65 program and determines in many cases whether chemicals or other substances meet the scientific and legal requirements to be placed on the Proposition 65 list. The agency uses a "Labor Code" listing mechanism, which directs the OEHHA to add chemicals or substances to the Prop 65 list of chemicals known to the state to cause cancer if they meet certain classifications by the IARC.

Monsanto's lawsuit against OEHHA argued that the statutory basis underlying the agency's action to list glyphosate as a Prop 65 chemical violates both the California and U.S. Constitutions. According to the complaint, listing glyphosate as chemical known to the state to cause cancer cedes regulatory authority to an "unelected, undemocratic, unaccountable, and foreign body" that isn't subject to oversight by California or the United States.

Though, according Judge Kapetan ruling:

"… the Labor Code listing mechanism does not constitute an unconstitutional delegation of authority to an outside agency, since the voters and the legislature have established the basic legislative scheme and made the fundamental policy decision with regard to listing possible carcinogens under Proposition 65, and then allowed the IARC to make the highly technical fact-finding decisions with regard to which specific chemicals would be added to the list.

"As Monsanto admits, the IARC's list is not created in response to the Labor Code listing mechanism or Proposition 65, and in fact IARC has stated that it disavows any policy or rulemaking role, and that it does not intend its determinations to carry the force of law."

In the months that followed, a number of interested nonparties joined the lawsuit as "intervenors," either on behalf of Monsanto or on behalf of the State of California. When a case has the potential to affect the rights of interested nonparties (individuals or organizations not named in the lawsuit), they can become intervenors, effectively joining the litigation either as a matter of right or at the court's discretion without the permission of the original litigants. Intervention simply gives nonparties that could be affected by a case's outcome a chance to be heard.

Below are the intervenors in Monsanto Company v. Office of Environmental Health Hazard Assessment, et al.

Monsanto Intervenors:

  • California Citrus Mutual
  • Western Agricultural Processors Association (WAPA)
  • California Cotton Ginners and Growers Associations
  • California Grain & Feed Association
  • Almond Alliance of California
  • Western Plant Health Association

OEHHA Intervenors:

  • Center for Food Safety
  • Sierra Club
  • United Steel, Paper and Forestry, Rubber, Manufacturing, Energy, Allied Industrial and Service Workers International Union (AFL-CIO, CLC)
  • Natural Resources Defense Council
  • Environmental Law Foundation
  • Canadian Labor Congress

Teri McCall is one of many California residents to cheer the ruling against Monsanto. Her husband, Jack, sprayed Roundup on the family's Cambia, California farm for nearly 30 years. In September 2015, Jack went to see a doctor to treat swollen lymph nodes in his neck. That day in the hospital, he learned that the swelling was caused by anaplastic large cell lymphoma (ALCL), a rare and aggressive version of non-Hodgkin lymphoma.

Three months later, Jack suffered a severe stroke due to complications with his cancer treatment. He died on Dec. 26, 2015.

In the wake of her husband's death, Teri McCall filed a wrongful death lawsuit against Monsanto, alleging the company knew about the link between Roundup and cancer, but failed to warn the public about the risk.

"My husband Jack was very conscious of the dangers of chemicals and his misfortune was taking Monsanto's word that Roundup was safe," McCall said at a press conference held in January in Fresno, California, following Judge Kapetan's tentative ruling.

"I don't want to see any more unsuspecting people die from cancer because they didn't know of the danger to their health from exposure to Roundup. Glyphosate in Roundup needs to be on the list of Prop 65 chemicals that are dangerous to our health so that people can make informed decisions for themselves about the risks they are willing to take. I don't believe my husband would have been willing to take that risk," McCall said.

It's great to see democracy is alive and well in California where judges are still willing to stand up for science, even against the most powerful corporate polluters. This decision gives Californians the right to protect themselves and their families from chemical trespass.

I am representing Ms. McCall along with Baum, Hedlund, Aristei & Goldman. We are also representing 230 other plaintiffs (45 from California) who are suing Monsanto for non-Hodgkin lymphoma from exposure to Roundup, with more clients coming onboard every week.

Health

A landmark new study has found metal debris and biological contamination in every human vaccine tested. The study should have profound and immediate impact on public health policies and vaccine industry procedures around the globe.

A team of scientists used a highly sensitive technology—an Environmental Scanning Electron Microscope equipped with an x-ray microprobe—to scan for solid contaminants in 44 samples of 30 vaccines. The researchers reported their results in the International Journal of Vaccines and Vaccination. They found widespread contamination by toxic aluminum salts, red blood cells of unknown origin and inorganic, foreign particle debris in aggregates, clusters and independent particulates. The composition of those clusters, the researchers observe, are consistent with "burnt waste."

Further analyses of those particles revealed them to be "non-biocompatible and bio-persistent foreign bodies" composed of lead, stainless steel, chromium, tungsten, nickel, iron, zirconium, hafnium, strontium, antimony and other metals. The investigators also identified some particles embedded in a biological substrate, probably proteins, endotoxins and residues of bacteria. The researchers found contamination in 43 of the 44 vaccine samples tested. The authors stated that these contaminants should not be present in any vaccine, and that their presence was not declared by the manufacturers. Ironically, the one sample that came back clean was a veterinary vaccine.

The team of scientists from the International Clean Water Institute, USA and the Italian National Research Council Institute of the Science and Technology of Ceramic materials, and Nanodiagnostics srl, Italy, was lead by Dr. Antonietta Gatti. In interviews with myself and James Lyons-Weiler, Dr. Gatti recounted the history of the investigation:

"Our analyses on vaccines started by accident about 15 years ago when Germany's University Hospital of Mainz asked us to analyze samples of an anti-allergy vaccine they administered." The vaccination had caused painful swellings around the injection point, and the formation of wheals that refused to subside. "We analyzed the samples of both vaccines and wheals and found solid particles inside both of them. Those particles should not have been there."

Dr. Gatti explains that the discovery of vaccine impurities shocked the researchers. "We had never questioned the purity of vaccines before. In fact, for us the problem did not even exist. All injectable solutions had to be perfectly pure and that was an act of faith on which it seemed impossible to have doubts. For that reason, we repeated our analyses several times to be certain. In the end, we accepted the evidence."

The revelations at Mainz caused the scientists to wonder if the debris problem might be more widespread and whether it might help explain a slew of mysterious adverse vaccine reactions reported by the industry. As an example, the authors quote post-marketing adverse event surveillance data associated with Tripedia (DTaP) vaccine, as reported by the manufacturer in the product insert. These reactions included "idiopathic thrombocytopenic purpura, SIDS, anaphylactic reaction, cellulitis, autism, convulsion/grand mal convulsion, encephalopathy, hypotonia, neuropathy, somnolence and apnea." According to Gatti, "No satisfactory explanation has been given as to why these adverse events occur." These questions prompted the researchers to investigate material contamination in vaccine products.

Dr. Gatti and her husband, Dr. Stefano Montanari, are well-known as the discoverers of nanopathologies—diseases caused by micro and nano particles. Dr. Gatti speculated about the fate of the inorganic vaccine contaminants in the human body:

"The particles, be they isolated, aggregated or clustered, are not supposed to be there. … Our tissues perceive these foreign bodies as potential enemies. The biological reactions are expected to be fairly complicated, with macrophages that try to engulf them the way they do normally with bacteria and parasites to form a protein corona. Unfortunately, though, the particles we found in vaccines, are not biodegradable. So, all the macrophages' efforts will be useless, and depending on the exact chemicals involved, the particles may be especially toxic. Cytokines and pro-inflammatory substances in general are released and granulated tissue forms, enveloping the particles. This provokes inflammation which, in the long run, if locally persistent, is known to be a precursor to cancer."

Asked to explain how the contamination got into the vaccines, Dr. Gatti replied, "That's a question we can't answer. We would need to inspect the laboratories where vaccines are produced, but no pharmaceutical company would allow us to do so."

Gatti told me that she contacted Sanofi Pasteur, a manufacturer of one of the contaminated vaccines. The company's only reaction was to dismiss her findings as impossible. Gatti speculates that the companies ignore this type of contamination because regulators are focused only on biological impurities in the manufacturing process.

She said, "Generally speaking, the good manufacturing procedures those laboratories are bound to follow, are focused on organic and biological matter, but disregard inorganic particulates." Dr Gatti remarked on the researchers' finding that the animal vaccine (Feligen) was clean of any particulate matter, debris or other contaminants, saying, "It is evidently possible to produce a clean vaccine."

Gatti told me that she and her research team have reported their alarming findings to the vaccine industry and to Italian health authorities. They urged that regulators and industry begin employing technologies to prevent this kind of contamination. "From my point of view, which is a merely technical one, she said, it's easy, you learn how to check vaccines … you forbid polluted vaccines to be distributed. This would immediately ensure that producers take appropriate counter-measures, for example, by working in a truly clean environment and carrying out their analyses the way they should be done."

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On the occasion of our announcement of the World Mercury Project's $100K challenge, we want to address America's reporters, journalists, columnists, editors, network anchors, on-air doctors and news division producers.

We especially want to reach out to those of you who have made a point of assuring the public about the safety of the mercury-based preservative, thimerosal. It's our hope that this challenge will elevate this important debate beyond name calling and prompt a genuine examination of the relevant science. The American public is entitled to an honest, probing and vigorous discussion about this critical public health issue—a debate based on facts, not rooted in fear, or on blind faith in regulators and the pharmaceutical industry.

We are both pro-vaccine. We need to say this at the outset to contravene the reflexive public relations ploy of labeling every vaccine safety advocate "anti-vaccine." As the British Medical Journal pointed out last week, that epithet is a derogatory attack designed to marginalize vaccine safety advocates and derail reasoned debate:

"It stigmatizes the mere act of even asking an open question about what is known and unknown about the safety of vaccines."

Both of us had all of our children vaccinated and we support policies that promote vaccine coverage. We want vaccines that are as safe as possible, robust transparent science and vigorous oversight by independent regulators who are free from corrupting conflicts-of-interest.

Despite the cascade of recent science confirming that thimerosal is a potent neurotoxin that damages children's brains, the American media has fiercely defended the orthodoxy that mercury-based vaccines are safe. We believe that even a meager effort at homework will expose that contention as unsupported by science. In just the past month, a Centers for Disease Control and Prevention (CDC) review confirmed thimerosal's profound neurotoxicity and a Yale University study connected vaccines to neurological illnesses including OCD, anorexia and tics.

Journalists, we have discovered—even science and health journalists—don't always read the science! On the vaccine issues, many of them have let government and industry officials tell them what the science supposedly says. Instead of questioning, digging and investigating, journalists, too often, have taken the easy course of repeating the safety assurances of the pharmaceutical industry and the regulators at CDC's Immunization Safety Office, which they have good reason to doubt.

For example, in recent years, two federal reports by Congress and the inspector general of the U.S. Department of Health and Human Services have criticized the CDC for politicization of science and for corrupting conflicts of interest with the pharmaceutical industry (see also: UPI article on CDC corruption). In August 2014, CDC's senior vaccine scientist, Dr. William Thompson, confessed that the CDC routinely manipulates data to conceal the links between vaccines and a host of neurological disorders. Some dozen other CDC scientists have since come forward to protest pervasive scientific fraud and research corruption at the CDC. Nevertheless, among American journalists, cult-like parroting of the CDC's safety assurances has become a kind of lazy man's science.

Health

A team of researchers from the Yale School of Medicine and Penn State College of Medicine have found a disturbing association between the timing of vaccines and the onset of certain brain disorders in a subset of children.

Analyzing five years' worth of private health insurance data on children ages 6-15, these scientists found that young people vaccinated in the previous three to 12 months were significantly more likely to be diagnosed with certain neuropsychiatric disorders than their non-vaccinated counterparts.

This new study, which raises important questions about whether over-vaccination may be triggering immune and neurological damage in a subset of vulnerable children (something parents of children with autism have been saying for years), was published in the peer-reviewed journal Frontiers in Psychiatry, Jan. 19.

More than 95,000 children in the database that were analyzed had one of seven neuropsychiatric disorders: anorexia nervosa, anxiety disorder, attention deficit and hyperactivity disorder (ADHD), bipolar disorder, major depression, obsessive-compulsive disorder (OCD) and tic disorder.

Children with these disorders were compared to children without neuropsychiatric disorders, as well as to children with two other conditions that could not possibly be related to vaccination: open wounds and broken bones.

This was a well-designed, tightly controlled study. Control subjects without brain disorders were matched with the subjects by age, geographic location and gender.

As expected, broken bones and open wounds showed no significant association with vaccinations.

New cases of major depression, bipolar disorder or ADHD also showed no significant association with vaccinations.

However, children who had been vaccinated were 80 percent more likely to be diagnosed with anorexia and 25 percent more likely to be diagnosed with OCD than their non-vaccinated counterparts. Vaccinated children were also more likely to be diagnosed with an anxiety disorder and with tics compared to the controls.

In a carefully worded conclusion, the researchers caution making too much of these results while also urging further investigation. "This pilot epidemiologic analysis implies that the onset of some neuropsychiatric disorders may be temporally related to prior vaccinations in a subset of individuals," they write. "These findings warrant further investigation, but do not prove a causal role of antecedent infections or vaccinations in the pathoetiology of these conditions."

We all know that correlation (in this case, vaccine administration in the previous 12 months and new diagnoses of brain disorders) does not necessarily mean causation.

But if certain vaccines or a combination of vaccines are actually triggering brain disorders, it is imperative that we figure out which vaccines, or combination of vaccines, are the culprits and what risk factors may make some children more susceptible than others.

Of particular concern is the influenza vaccine. In this study, influenza vaccination was strongly correlated with both anorexia and OCD. At the same time, new research by the Centers for Disease Control and Prevention scientists has shown the mercury-containing preservative thimerosal to be as toxic and as brain damaging as other forms of mercury. Yet multi-dose flu vaccines still contain thimerosal, and flu vaccines are recommended for pregnant women and infants in America despite questions about efficacy and the scientifically documented risks.

Why look for a correlation between vaccination administration and brain disorders?

As the researchers point out, two major studies, one from researchers in Norway and one from an international team of researchers from Finland, Italy and Denmark, have shown an increased risk of narcolepsy following administration of the H1N1 flu vaccine.

Another study from China found an increased risk of narcolepsy after the H1N1 flu itself, which was unlikely to be linked to vaccinations.

If we look at this data from the H1N1 flu outbreaks, we see that immune responses—whether to the disease itself or to vaccination against the disease—can damage the brain.

While new discoveries about the human immune system are being made all the time, it is well understood that the immune system plays a role in brain development and in certain psychiatric conditions, including attention disorders, eating disorders, obsessive disorders and depression.

It is also well understood that the body's immune response involves inflammation, which is when tissue swells in response to harmful stimulation. Harmful stimulation includes infectious diseases (that is, illnesses themselves), environmental toxins like mercury, and allergens like pollen or dust mites (which are actually benign, though an over-stimulated immune system perceives them as threats).

We further know that vaccination can cause inflammation, which is part of the body's natural response to foreign substances.

Previous scientific studies have shown that when an immune reaction causes inflammation, it can negatively affect the brain.

So it is scientifically plausible and more than reasonable to investigate whether vaccination itself, which provokes inflammation, may also negatively affect the brain.

I agree with these researchers that the correlation between anorexia, OCD, tic disorder, anxiety disorder and vaccinations warrants further scrutiny. This study suggests that the seemingly inexplicable increase we have seen in brain disorders among young children may not be so mysterious after all.

To sign up for updates from Robert F. Kennedy, Jr., go to the World Mercury Project.

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The U.S. Environmental Protection Agency (EPA) and U.S. Food and Drug Administration (FDA) once again advised pregnant women to curb consumption of fish in order to limit fetal exposures to neurotoxic mercury. This warning raises the baffling query: How can the Centers for Disease Control and Prevention (CDC) justify its recommendations that pregnant women get flu shots which are laden with far more mercury than what's found in a can of tuna?

The CDC has long answered that nettlesome question with the controversial claim that ethylmercury in vaccines is not toxic to humans. Now, two CDC scientists have published research decisively debunking that assertion. As it turns out, there is no "good mercury" and "bad mercury." Both forms are equally poisonous to the brain.

The CDC study, Alkyl Mercury-Induced Toxicity: Multiple Mechanisms of Action, appeared last month in the journal, Reviews of Environmental Contamination and Toxicology. The 45-page meta-review of relevant science examines the various ways that mercury harms the human body. Its authors, John F. Risher, PhD, and Pamela Tucker, MD, are researchers in the CDC's Division of Toxicology and Human Health Sciences, Agency for Toxic Substances and Disease Registry.

"This scientific paper is the one of most important pieces of research to come out of the CDC in a decade," Paul Thomas, M.D., a Dartmouth-trained pediatrician who has been practicing medicine for 30 years, said. "It confirms what so many already suspected: that public health officials have been making a terrible mistake in recommending that we expose babies and pregnant women to this neurotoxin. I regret to say that I gave these shots to children. The CDC led us all to believe that it was perfectly safe."

Among the findings of the CDC's new study:

  • Methylmercury, the highly-regulated neurotoxin found in fish, and ethylmercury (found in medical products, including influenza and tetanus vaccines, ear drops and nasal sprays) are similarly toxic to humans. Methylmercury and ethylmercury share common chemical properties, and both significantly disrupt central nervous system development and function.
  • Thimerosal is extremely toxic at very low exposures and is more damaging than methylmercury in some studies. For example, ethylmercury is even more destructive to the mitochondria in cells than methylmercury.
  • The ethylmercury in thimerosal does not leave the body quickly as the CDC once claimed, but is metabolized into highly neurotoxic forms.

Despite this stark rejection of a decade of CDC safety assurances, CDC's public relations machine is still bucking the new scientific consensus; the article concludes with a telling disclaimer in tiny font:

"The findings and conclusions in this report are those of the authors and do not necessarily represent the views of the Agency for Toxic Substances and Disease Registry."

CDC's website continues to feature now discredited safety assurances.

"Baldly dismissing the danger to humans from ethylmercury, has long been a reckless gambit," said J.B. Handley, a Portland, Oregon, businessman who believes that his son received debilitating injuries from a mercury vaccine. "With this study, by its own scientists, the CDC has now edged into the realm of criminal endangerment."

Handley, the founder of Generation Rescue, a vaccine safety advocacy group, condemns the CDC for misleading the medical establishment.

"The CDC knows that pediatricians and physicians rely on its public pronouncements when they make treatment decisions for their patients; how can we escape the conclusion that the agency is knowingly causing the poisoning of tens of millions of American children," Handley stated.

For example, CDC's webpage still parrots the now discredited industry canard that:

"Thimerosal contains ethylmercury, which is cleared from the human body more quickly than methylmercury, and is therefore less likely to cause any harm."

However, the new study makes the opposite conclusion:

"Thimerosal is quickly metabolized in vivo (in a living organism) due to its reactions with protein and non-protein thiols … so the effects of thimerosal reported in numerous articles are very likely the result of exposure to the metabolite ethylmercury."

Ignoring the agency's own scientific evidence, the CDC's webpage stubbornly insists that the "two types of mercury to which people may be exposed—methylmercury and ethylmercury—are very different." The new CDC study directly contradicts this assertion, "There are many commonalities/similarities in the mechanisms of toxic action of methylmercury and ethylmercury …"

The study meticulously details identical toxicity pathways shared by both forms of mercury:

  • Both ethyl and methyl mercury cause DNA damage or impair DNA synthesis (Burke et al. 2006; Sharpe et al. 2012; Wu et al. 2008).
  • Both cause oxidative stress/creation of reactive oxygen species (Dreiem and Seegal 2007; Garg and Chang 2006; Myhre et al. 2003; Sharpe et al. 2012; Yin et al. 2007).
  • Both decrease glutathione activity, thus providing less protection from the oxidative stress caused by MeHg and EtHg (Carocci et al. 2014; Ndountse and Chan (2008); Choi et al. 1996; Franco et al. 2006; Mori et al. 2007; Muller et al. 2001; Ndountse and Chan 2008; Wu et al. 2008).
  • Both cause effects on cell division by damaging the spindle apparatus during mitosis (Burke et al. 2006; Castoldi et al. 2000; Gribble et al. 2005; Kim et al. 2007; Ou et al. 1999b; Machaty et al. 1999; Rodier et al. 1984).
  • Both MeHg and EtHg bind to the amino acid cysteine (Clarkson 1995; Wu et al. 2008).
  • Both MeHg and EtHg strongly inhibit the reacylation of arachidonic acid, thus inhibiting the reincorporation of this fatty acid into membrane phospholipids (Shanker et al. 2002; Verity et al. 1994; Zarini et al. 2006).
  • Both cause an increase in NOS, causing an overproduction of NO (Chen et al. 2003; Chuu et al. 2001; Shinyashiki et al. 1998).
  • Both disrupt glutamate homeostasis (Farina et al. 2003a, b; Manfroi et al. 2004; Mutkus et al. 2005; Yin et al. 2007).
  • Both alter intracellular calcium homeostasis (Elferink 1999; Hare et al. 1993;Kang et al. 2006; Limke et al. 2004b; Machaty et al. 1999; Marty and Atchison1997; Minnema et al. 1987; Peng et al. 2002; Sayers et al. 1993; Sirois and Atchison, 2000; Szalai et al. 1999; Tornquist et al. 1999; Zarini et al. 2006).
  • Both cause effects on receptor binding/neurotransmitter release involving one or more transmitters (Basu et al. 2008; Coccini et al. 2000; Cooper et al. 2003; Fonfria et al. 2001; Ida-Eto et al. 2011; Ndountse and Chan 2008; Yuan and Atchison 2003).

"This study is a nuclear bomb detonating over the CDC," Boyd Haley, chairman emeritus of the University of Kentucky Chemistry Department, said. "It should be getting international, front page headlines."

As one of the world's leading authorities on mercury toxicity, Haley observed, "It's a momentous rejection of a widely held medical orthodoxy dictating policy changes even more significant than the medical establishment's reversals on thalidomide, calomel tooth powder, x-rays during pregnancy, or lead exposure to children. In each of these cases, thousands of children were injured or killed before an entrenched medical establishment was finally willing to abandon treatments that were unquestionably causing great harm."

Ethylmercury vs. Methylmercury in Mass Poisonings

The revolutionary conclusions of the new CDC study actually reflect decades of work by mainstream independent scientists outside the agency. A rich scientific literature that emerged from accidental poisoning events has consistently documented—despite CDC's official claims—that ethylmercury and methylmercury are equally toxic. In addition to the well-known Minamata and Iraq methylmercury-poisoning, many other large-scale food poisonings have occurred involving ethylmercury fungicides in Iraq in 1956 and 1960, in Pakistan in 1961, and in Russia in the 1960s as well. These episodes resulted in maladies ranging from basic tissue injury to heart and brain injury and even death.

Derban reported in 1974 on 144 cases of mercury poisoning from the use of ethylmercury fungicide on a southern Ghana state farm. Multiple other studies based on these poisoning events showed, as stated in a 1977 study by David Fagan, that the long-term neurological consequences produced by the "ingestion of either methyl or ethyl mercury-based fungicides are indistinguishable."

A 1979 case report concerned a fifteen-year-old boy who had eaten the meat of a pig that had fed on ethylmercury fungicide−treated seed. Documented effects on the boy included debilitating brain damage and loss of coordination, with high toxicity for the brain as well as the spinal motor neurons, peripheral nerves, skeletal muscles, and heart muscle. The boy died about one month after becoming ill.

Ethylmercury's use as pesticide was eventually banned in many countries, including the United States and those in the European Union, and for good reason: A 1977 study gauged ethylmercury chloride's relative toxicity as a pesticide as the fifth most toxic of thirty substances tested, with a score of 12.7. That grade score almost matched that of DDT, at 14.2, an infamous pesticide banned in 1972.

In 1977 Fagan reported on 13 children suffering from exomphalos (a rare abdominal wall defect that allows the intestines to protrude from the abdomen) treated with gauze soaked applications of thimerosal to prevent infection. Of thirteen patients treated with thimerosal, 9 died. The authors tested mercury levels in the tissue of 8 of the children who died. They reported that "blood and tissue levels of mercury well above the threshold at which damage occurs in all other age groups, it is extremely unlikely that these infants escape neurological damage, which may be subtle." One infant exposed to thimerosal and survived was later reported as being "restless, easily distracted, and not interested in schoolwork." The authors recommended that "organic mercurial antiseptics should be heavily restricted or withdrawn from hospital use, as the fact that mercury readily penetrates intact membranes and is highly toxic seems to have been forgotten."

Why Does the US EPA only Provide Guidelines for Exposure to Methylmercury and not Ethylmercury?

In 1995, based on research from outbreaks of poisonings and other research from the Faroe Islands and the Seychelles, the EPA established a safe "reference dose" for methyl mercury (RfD). An RfD is defined as "an estimate of a daily exposure to the human population (including sensitive subgroups) that is likely to be without an appreciable risk of adverse effects when experienced during a lifetime," according to the EPA.

The EPA adopted for methylmercury an RfD of 0.1 microgram of mercury per kilogram of the individual's body weight per day. Other health agencies set their own recommended limits for methylmercury exposure, including the FDA in 1979, the World Health Organization in 1989 and the US Agency for Toxic Substances and Disease Registry (ATSDR) in 1999. The highest of these limits was the WHO's, at 0.47 microgram per kilogram of body weight per day.

In 1999 the US Congress directed the EPA to contract with the nonprofit, independent National Research Council (NRC) to prepare recommendations on an updated and appropriate RfD. The EPA commissioned the National Academy of Sciences (NAS) and the NRC to carry out a study on toxicological effects of methylmercury compounds. The goal was to review the process used by the EPA to establish national safety standards. The committee evaluated the literature, which demonstrated methylmercury compounds' high toxicity to brain tissue, even at minute levels. The NAS ultimately agreed with the EPA's originally conceived RfD, which remains in place today. An RfD has never been established for ethylmercury.

The CDC has crossed ethical and perhaps even legal boundaries by purposefully blocking efforts by the National Institute of Environmental Health Science's (NIEHS) National Toxicology Program (NTP) to test ethylmercury for toxicity – a process that would have lead to maximum exposure guidelines. In 2000, the FDA nominated thimerosal to the NTP for toxicity testing. However, CDC officials derailed the review telling the NTP committee that "There is a great concern within CDC about continued attacks from anti-vaccine groups questioning the integrity of CDC activities and recommendations regarding the use of thimerosal-containing vaccine." In response to CDC pressure, the NTP put thimerosal on permanent deferred status. Thimerosal has, therefore, never been tested for safety or toxicity.

Ethyl Mercury Exposure Levels Based on Methyl Mercury Guidelines

A single Thimerosal-preserved flu vaccine contains 25 micrograms of ethylmercury. If the EPA RfD for ingested methylmercury is applied to this injected ethylmercury figure, an individual would have to weigh more than 250 kilograms (551 pounds) for the 25 microgram exposure to be considered safe. Back in the 1990s, a two-month-old child could have received 62.5 micrograms from three vaccines in a single doctor's visit. Assuming the child weighed about 5 kilograms (11 pounds), he or she would have received 125 times the EPA RfD for methylmercury.

At least one study has suggested that the methylmercury RfD should be set lower for infants and also for fetuses. In 1995, Steven Gilbert and Kimberly Grant-Webster wrote: "Available information on the developmental neurotoxic effects of MeHg [methylmercury], particularly the neurobehavioral effects, indicates that the fetus and infant are more sensitive to adverse effects of MeHg. It is therefore recommended that pregnant women and women of childbearing age be strongly advised to limit their exposure to potential sources of MeHg. Based on results from human and animal studies on the developmental neurotoxic effects of methylmercury, the accepted reference dose should be lowered to 0.025 to 0.06 MeHg [microgram]/kg/day."

What might this mean for a fetus today? We'll take the low end of that estimate and apply it to an average 1.15-kilogram (2.54-pound) fetus at the start of the third trimester. A fetus exposed to 25 micrograms of mercury via a Thimerosal-preserved flu shot administered to its pregnant mother could be subject to 870 times the proposed lower reference dose.

Mainstream Science Suggests Ethylmercury is More Toxic than Methylmercury

New and old research support the caveat that "safe" levels of ethylmercury exposure might indeed be dramatically lower than the EPA's RfD. A 2012 Italian study, for instance, showed that ethylmercury-containing Thimerosal diminished the viability of human cells in the lab at a concentration one-fiftieth that of methylmercury. By this measure, ethylmercury is 50 times as toxic as methylmercury to humans.

Japanese research on rats in 1968 showed that ethylmercury compounds, such as ethylmercuric chloride from which Thimerosal is made, clear the body more slowly than other mercury compounds including mercuric chloride and phenylmercuric chloride.

A book chapter in 1972 by Staffan Skerfving, an emeritus professor at Lund University in Sweden, reviewed literature on methylmercury versus ethylmercury, noting several instances where compounds of the latter appeared more toxic than the former in animal studies.

For example, ethylmercury chloride killed off half of a test population of mice—a classic "LD50" (lethal dose) study—within a week at a concentration of 12 milligrams of mercury per kilogram of body weight; methylmercury chloride's LD50, meanwhile, lethal to half the mice was 14 milligrams. This study suggested that ethylmercury was twice as toxic.

Further examples abound. Pig studies by Tryphonas and Nielsen in 1973 showed that ethylmercury "proved much more toxic" than methylmercury. Meanwhile, another 1973 study that emerged from a 1971 international conference found the toxicity of ethylmercury compounds comparable to or even greater than that of methylmercury, as well as more persistent in the brain.

An advisory committee at the conference reported that the International Committee on Maximum Allowable Concentration for Mercury and Its Compounds grouped ethylmercury with methylmercury, and observed that accounts of human intoxication with ethylmercury have usually described neurological and other symptoms similar to those of methylmercury. The report noted that in studies of patients transfused with a commercial product of human plasma containing 0.01 percent Thimerosal, as well as in studies of mice injected with an ethylmercury solution, the increased level of inorganic mercury added to the mercury already existing in the body resulted in a "longer biological half-life of total mercury than that reported for methylmercury injection."

Why do the CDC and WHO Report that Ethylmercury Exposure is Safe?

The WHO's conclusion that ethylmercury is safer because of its "short" half-life may be based on observations that ethylmercury disappears from blood samples quicker than methylmercury. However, this tendency may be evidence not of ethylmercury's comparative safety, but of its greater danger if, as science has suggested, ethylmercury is not leaving the body but simply migrating more rapidly to the organs, including the brain. Indeed, studies have shown that an ethylmercury compound's short residence in the blood stems from its ability to more easily pass into the organs, where it can remain for long periods and possibly cause injury.

For example, Blair in 1975 dosed squirrel monkeys with intranasal saline or Thimerosal daily for six months, finding that, compared to the saline group, mercury concentrations in the Thimerosal group were significantly raised in the brain, liver, muscle, and kidney, though not in the blood. Although there were no signs of toxicity in the animals, Blair concluded that the "accumulation of mercury from chronic use of thiomersal-preserved medicines is viewed as a potential health hazard for man."

Beyond a possibly greater capacity to have inorganic mercury accumulate in organs, Thimerosal also passes more easily from a mother's bloodstream through the placenta into a developing baby than does methylmercury. That was the evaluation made in a 1983 review study by A. Leonard. In addition, a 1995 study demonstrated that both ethylmercury and methylmercury cause mutagenic changes at similar concentrations in bacterial cells.

The Twisted Saga of Pichichero

With these and other studies as background, an important study in humans took place in the early 2000s. The study, by Michael Pichichero of the University of Rochester Medical Center and published in The Lancet in 2002, lent some apparent scientific credence to the idea that ethylmercury is safer than methylmercury. Pichichero, who helped develop the HiB vaccine and previously received grants and honoraria as a consultant for other vaccine makers, did not declare these conflicts of interest in a statement in his paper, as required by The Lancet's peer review rules. The Pichichero study assessed mercury levels in the blood, urine, and feces of forty infants ages six months or younger three to twenty-eight days after they had received Thimerosal-preserved vaccines (DTaP, HepB, and in some cases Hib). For comparison, twenty-one similar infants who received Thimerosal-free vaccines were also evaluated. Although infants who received Thimerosal-preserved vaccines had higher levels of mercury in their blood, urine, and feces than did the infants who received Thimerosal-free vaccines, the authors concluded that the levels of mercury detected were not greater than what is considered safe. Most of the mercury from the injected Thimerosal seemed to have left the children's bloodstreams more rapidly than methylmercury found in the blood of those eating fish in previous studies; the researchers estimated a half-life of seven days for ethylmercury in the blood. Pichichero concluded that ethylmercury, therefore, did not remain in children's bodies long enough to possibly cause damage.

Pichichero's study immediately came under attack by internationally respected scientists in a 2003 letter to The Lancet by Neal Halsey, of the Institute for Vaccine Safety at Johns Hopkins Bloomberg School of Public Health, and Lynn Goldman, also of the Bloomberg School of Public Health. Halsey and Goldman pointed out that Pichichero and colleagues "did not measure the peak blood concentrations that occurred within hours after the injections." The concentration listed for one child in the study of 20.55 nanomoles per liter was obtained five days post-vaccination. Assuming Pichichero's own estimate of an ethylmercury half-life in the blood of seven days, the peak blood concentration for this child was 29.4 nanomoles per liter—exceeding the conventional safety threshold of 29.0 nanomoles per liter, and contradicting the study's claim that "no children had a concentration of blood mercury exceeding 29 nmol/L." The child in question had received 37.5 micrograms of ethylmercury rather than the possible maximum exposure of 62.5 micrograms. In the latter scenario, the child's peak blood mercury concentration would have hit 48.3 nanomoles per liter.

Another child in the study registered a 7 nanomole per liter blood concentration 21 days post-vaccination; extrapolating backwards, this child's peak mercury level might have reached 42 nanomoles per liter. Halsey and Goldman's letter further pointed out that Pichichero seemed to have cherry-picked the children in the study—some already with no margin of safety for further mercury exposure—seemed to have come from a population with low background environmental and maternal exposure to methylmercury.

Soon after publication of Pichichero's study, alarming new evidence emerged that ethylmercury lingers in the body. In an unpublished letter submitted to Pediatrics, Dr. Boyd Haley, then-chairman of the chemistry department at the University of Kentuck, and Mark Blaxill challenged Pichichero's hypothesis that ethylmercury is quickly excreted. Pichichero and colleagues had measured the excretion levels of mercury in the stools of 22 healthy infants exposed to Thimerosal-containing vaccines. Pichichero's estimated range for the infants aged two and six months was 23 to 141 nanograms per gram of stool (dry weight). Assuming the excretion rate reported by Pichichero, Blaxill and Haley demonstrated that it could take children with low excretion rates of mercury in their stool almost four years to eliminate a 187.5 microgram mercury burden from their bodies.

In 2006, Luis Maya and Flora Luna further debunked Pichichero's conclusions. The authors pointed out that while Pichichero's team had found ethylmercury to be excreted in appreciable quantities in the feces, the researchers did not study other body parts beyond the blood, such as the central nervous system. In agreement with Halsey and Goldman, Maya and Luna criticized Pichichero for neglecting to measure the peak serum levels of ethylmercury after the first hours of inoculation, though other investigations had documented substantially elevated blood concentrations in the first 48 to 72 hours after administration in pediatric vaccines. Maya and Luna also pointed out that the study was small and measured variables of pharmacokinetics (the actions of a drug within the body over time), so it was not designed to measure the biological effect of Thimerosal as a preservative.

Pichichero Redux: Yes, Ethylmercury Rapidly Leaves the Blood, but Not the Body. It Lodges in the Brain!

By then, other research had clarified that, while ethylmercury disperses quickly from the bloodstream, this is not evidence of safety. For example, a 2004 study by G. Jean Harry of the National Institute of Environmental Health Sciences noted that mice injected with Thimerosal accumulated mercury in both the brain and kidneys. "By seven days" post-treatment, the study authors wrote, "mercury levels decreased in the blood but were unchanged in the brain" compared to levels measured just 24 hours after treatment, indicating slow clearance.

The landmark study in this regard was conducted by the University of Washington's Thomas Burbacher and published in 2005. The researchers compared mercury levels in the blood and brains of infant macaques injected with Thimerosal-containing vaccines with monkeys who ingested equal amounts of methylmercury hydroxide via a feeding tube. The former group of primates were exposed to 20 micrograms of ethylmercury per kilogram of body weight on the day they were born and when they were seven, 14, and 21 days old, which was estimated to be within the range of doses that children at different developmental stages were receiving in the United States. The dosing methods were selected to mimic the routes of exposure in humans who eat mercury-containing foods and receive mercury-containing vaccines.

Subsequent tests showed a faster disappearance of mercury from the bloodstream of Thimerosal-injected monkeys than from the methylmercury group. Total mercury amounts in the brain were also threefold less for the Thimerosal-treated monkeys. However, the Thimerosal-injected monkeys had a higher ratio of brain-to-blood levels of mercury than the methylmercury group. In general, the primates injected with Thimerosal in the Burbacher study retained twice the level of inorganic mercury—a breakdown product of Thimerosal that has been suggested to be responsible for the brain damage associated with methylmercury—in their brains as the methylmercury-exposed primates. While all seventeen monkeys given Thimerosal had "readily" detectable levels of inorganic mercury in their brains, only nine of the seventeen exposed to methylmercury had detectable levels. Burbacher cited previous research ranging the half-life of inorganic mercury in various brain regions of primates from 227 to 540 days. In either case, that is a long time period for the toxic element to remain, especially if at higher levels from ethylmercury deposition versus methylmercury.

Burbacher and his colleagues wrote in summary that "[methylmercury] is not a suitable reference for risk assessment from exposure to thimerosal-derived [mercury]" and that: Data from the present study support the prediction that, although little accumulation of [mercury] in the blood occurs over time with repeated vaccinations, accumulation of [mercury] in the brain of infants will occur. Thus, conclusion [sic] regarding the safety of thimerosal drawn from blood [mercury] clearance data in human infants receiving vaccines may not be valid, given the significantly slower half-life of [mercury] in the brain as observed in the infant macaques.

A more recent 2012 study by Croatian researchers took a similar approach as Burbacher's study, but in suckling rats. That study also discredits CDC's claims of ethylmercury's comparative safety. Maja Blanusa and colleagues gave rat pups either Thimerosal or inorganic mercury three times in their first 11 days of life, mimicking human infant vaccination schedules. The scientists then assessed the total retention of mercury and excretion over six days. The Thimerosal-exposed rats showed higher mercury retention rates in their brains. Furthermore, these Thimerosal-exposed rats exhibited similar fecal excretion and much lower urinary excretion compared to the inorganic mercury-exposed rats. That second group also demonstrated higher retention rates of mercury in organs other than the brain.

Two additional studies in the last few years by researchers in Brazil and Germany show, again, that methylmercury in particular should not be considered summarily more dangerous than ethylmercury. The studies found that cells similarly take up both forms of mercury. The former, by Luciana Zimmermann and colleagues, showed in 2013 that the methyl- and ethylmercury entered cultured rat cells in roughly equal measure and display similar toxicities. The 2014 German study led by Christoph Wehe used novel laboratory techniques in concluding that methylmercury and ethylmercury in the form of Thimerosal accumulated in equal measure in a type of cultured human neural cell.

Overwhelmingly, the literature presents clear evidence that ethylmercury is invasive and persistent in the brain. Emerging evidence suggests that ethylmercury is more toxic than methylmercury, in direct contrast with the CDC's historic position. It's time for CDC's public relations department to catch up with mainstream science. Since the World Health Organization (WHO relies mainly on CDC's vaccine safety science, the CDC's unscientific pronouncements endanger, not just U.S. children, but hundreds of millions of children around the world. Knowing what we now know, the U.S. Federal agencies and the WHO should follow the precautionary principle and phase out the use of thimerosal in all medical products, including vaccines.

Health

Uncovered documents show that the U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) knew that infant vaccines were exposing American children to mercury far in excess of all federal safety guidelines since 1999. The documents, created by a FDA consulting toxicologist, show how federal regulators concealed the dangerous impacts and lied to the public.

In 1997, Congress passed the FDA Modernization Act. A provision of that statute required the FDA to "compile a list of drugs that contain intentionally introduced mercury compounds, and provide a quantitative and qualitative analysis of the mercury compounds on the list." In response, manufacturers reported the use of the mercury-based preservative, thimerosal, in more than 30 licensed vaccines.

FDA's Center for Biologics Evaluation and Research (CBER) was responsible for adding up the cumulative exposure to mercury from infant vaccines, a simple calculation that, astonishingly, had never been performed by either the FDA or the CDC. When the agency finally performed that basic calculation, the regulators realized that a six month-old infant who received thimerosal-preserved vaccines following the recommended CDC vaccine schedule would have received a jaw dropping 187.5 micrograms of mercury.

Instead of immediately ordering the removal of thimerosal, FDA officials circled the wagons treating the public health emergency as a public relations problem. Peter Patriarca, then director of the FDA Division of Viral Products, warned his fellow bureaucrats that hasty removal of thimerosal from vaccines would:

" … raise questions about FDA being 'asleep at the switch' for decades by allowing a potentially hazardous compound to remain in many childhood vaccines, and not forcing manufacturers to exclude it from new products. It will also raise questions about various advisory bodies regarding aggressive recommendations for use. We must keep in mind that the dose of ethylmercury was not generated by "rocket science." Conversion of the percentage thimerosal to actual micrograms of mercury involves ninth grade algebra. What took the FDA so long to do the calculations? Why didn't CDC and the advisory bodies do these calculations when they rapidly expanded the childhood immunization schedule?"

The agency consulted with experts in the field of toxicology to better understand the potential impact of these exposure levels. One consultant was Barry Rumack, MD. Dr. Rumack, at the time, had a private consulting practice, Rumack Consulting, 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 blood and body burden levels in 1999.

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 the U.S. Environmental Protection Agency (EPA), FDA, and Agency for Toxic Substances and Disease Registry (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 120ng/liter. To put this in perspective, the CDC classifies mercury poisoning as blood levels of mercury greater than 10 ng/L.

After receiving this alarming news from its toxicological consultant, the FDA chose to conceal these acute exposures using a deceptive statistical trick. Instead of honestly reporting the dangerous spikes in pediatric blood levels, FDA's public documents averaged the exposures over a six month period despite the fact that the exposures only occurred on four days during that six month period: at birth, and at two, four and six months of age.

An analogy would be to compare taking two Tylenol tablets a day for a month to taking 60 Tylenol tablets in one day; the first exposure is acceptable, while the other is lethal. Using this misleading gimmick, regulators were able to report that mercury exposure levels were below FDA and ATSDR guidelines. Even after employing this deception, the levels were still above EPA guidelines which were the most stringent of the three. Numerous toxicologists have reported that the FDA's calculation, averaging these high bolus dose exposures, was not appropriate.

Additionally disturbing, the FDA assigned a pediatrician with little knowledge of toxicology to oversee its public reporting. When Dr. Leslie Ball was asked why she reported the mercury exposure levels in this deceptive fashion, she responded, "That is what I was told to do."

In an e-mail to her superiors at the FDA on July 6, 1999, marked as being highly important and confidential and obtained through a Freedom of Information Act request, Dr. Ball asked Norman Baylor, PhD, 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.'"

In further email discussion between the CDC and FDA regarding the development of a consensus statement on the use of thimerosal in influenza vaccination of pregnant women, William Egan, acting office director of the Office of Vaccine Research and Review, Center for Biologics Evaluation and Research at the FDA, commented:

"I'm 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 outcomes as having it spaced out evenly over a year; the issue then becomes 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)."

Despite Egan's well-reasoned revelations, FDA and CDC regulators went ahead with their dangerously misleading announcement.

With this deceitful calculation in hand, the Public Health Service and the American Academy of Pediatrics reported to the American public on July 9, 1999:

"There is a significant safety margin incorporated into all the acceptable mercury exposure limits. Furthermore, there are no data or evidence of any harm caused by the level of exposure that some children may have encountered in following the existing immunization schedule. Infants and children who have received thimerosal-containing vaccines do not need to be tested for mercury exposure."

Seventeen years later, thanks to the FDA's 1999 sleight of hand, neurotoxic thimerosal, an unnecessary and dangerous vaccine preservative, continues to be injected into pregnant women, infants and children in the U.S. pursuant to the CDC's recommendations and, in much larger doses, into hundreds of millions of children across the developing world.

Sophocles wrote, "All men make mistakes, but a good man yields when he knows his course is wrong, and repairs the evil. The only crime is pride." The U.S. Department of Agriculture's Ruth Etzel, MD, gave similar advice to her fellow regulators immediately after the FDA toxicologist repeated the monumental error by vaccine safety officials:

"The AAP should be dedicated to promptly providing truthful information about this situation to pediatricians. We must follow three basic rules:

  1. Act quickly to inform pediatricians that the products have more mercury than we realized.
  2. Be open with consumers about why we didn't catch this earlier.
  3. Show contrition.

"As you know, the Public Health Service informed us yesterday that they were planning to conduct business as usual and would probably express no preference for either product. While the Public Health Service may think that their 'product' is immunizations, I think their "product" is their recommendations. If the public loses faith in the PHS recommendations, then the immunization battle will falter. To keep faith, we must be open and honest now and move forward quickly to replace these products."

Ignoring Etzel's wise advice, the CDC elected to paper over their catastrophic mistake and double down on vaccine mercury. By continuing to allow thimerosal to be used in vaccines, the CDC is causing harm to American pregnant women, their growing babies and to 100 million children all over the planet. And now we have proof that our regulators know exactly what they are doing.

Visit the World Mercury Project to learn more and sign up for updates from Robert F. Kennedy, Jr.

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In November 2016, I reported on six studies that found strong relationships between biomarkers for mercury toxicity in children with autism including a direct correlation between the levels of mercury toxicity and the severity of autism symptoms. Those findings are supported by recent research that links industrial exposures of lead, mercury and arsenic to the prevalence of autism spectrum disorder (ASD).

The study, led by a team of 13 scientists from leading American universities and hospitals, was published in the July 2016 issue of Environmental Monitoring and Assessment. Investigators studied the Center for Disease Control and Prevention (CDC) data on 4,486 children with ASD residing in 2,489 census tracts across the country. They used an overlay of the Environmental Protection Agency regional air pollution data to determine if air concentrations of various metals could be connected with autism prevalence and found strong correlations between ambient concentrations of lead, mercury and arsenic and the occurrence of ASD. Tracts with air concentrations of lead in the highest quartile had significantly higher ASD prevalence than tracts with lead concentrations in the lowest quartile. In addition, tracts with mercury concentrations above the 75th percentile and arsenic concentrations below the 75th percentile had a significantly higher ASD prevalence compared to tracts with arsenic, lead and mercury concentrations below the 75th percentile.

An earlier study published in 2015 by an even larger research team found an association between urban residential proximity to industrial facilities emitting air pollutants (arsenic, lead or mercury) and higher autism prevalence.

Other recent studies have found significant associations between environmental sources of mercury exposure and ASD. A study, led by the Division of Environmental and Occupational Disease Control, California Department of Health Services published in Environmental Health Perspectives in 2006, implicated mercury, among other metals, as the air pollutant that is most associated with higher risks of ASD diagnoses among a sample of children born in the San Francisco Bay area in 1994. Meanwhile, a master's thesis completed at Louisiana State University in 2006 noted an association between mercury in fish and air emissions and developmental disorders, including autism.

Also in 2006 and then in 2009, researchers demonstrated that increases in environmental mercury emitted from power plants and distance from point sources of mercury exposure in Texas were significantly related to the risk of an individual being diagnosed with ASD. The 2006 study found that "on average, for each 1,000 lb of environmentally released mercury, there was a 43% increase in the rate of special education services and a 61% increase in the rate of autism." The 2009 study reported that "for every additional 10 miles of distance from industrial or power plant sources there was an associated decreased Incident Risk of 2.0% and 1.4%, respectively."

A 2013 study, primarily from Harvard researchers, found that women who lived in the areas with the highest levels of diesel particulates or airborne mercury were twice as likely to have a child with autism, compared with those who lived in the areas with the lowest levels of air pollution. Of the contaminants, "multi-pollutant models suggested mercury and methylene chloride to be the most robustly associated with autism," the study reported.

Clearly we are in desperate need to reduce exposures to these highly toxic metals that act synergistically in the body to cause harm. We are also in need of effective ways help restore health to those who have been injured.

Please visit World Mercury Project to learn more and sign up for updates from Robert F. Kennedy, Jr.

Health

A Nov. 19 study, of 45,231 women, published in JAMA Pediatrics, identified a heightened risk of autism spectrum disorder (ASD) diagnosis in the children of mothers who received a flu shot during their first trimester of pregnancy. The study, Association Between Influenza Infection and Vaccination During Pregnancy and Risk of Autism Spectrum Disorder, was authored by Ousseny Zerbo and his colleagues affiliated with the Division of Research at Kaiser Permanente.

While the researchers found no increased risk when the mother received flu shots in the second or third trimester, the data demonstrated a 20 percent higher risk of an autism spectrum disorder among children of mothers receiving the flu vaccine during the first trimester. That risk was statistically significant. (The P value, .01, indicates a 99 percent likelihood that the result isn't due to chance.)

However, after completing this analysis, the authors made a series of adjustments that have drawn criticism from other scientists. Most controversial was their questionable decision to apply a statistical device called the "Bonferroni Correction" to their data. Statisticians use the Bonferroni Correction in very specific circumstances—where they seek to reduce the chance for false positives in calculations involving multiple comparisons. The impact of the Bonferroni Correction is nearly always conservative; it dampens signals in data sets. In doing so it creates the risk of missing true associations. When applied to the first trimester flu vaccine dataset, the Bonferroni Correction reduced the significance of the association from 99 percent to 90 percent. Despite the fact that the adjusted result was still considered marginally statistically significant, the authors then made a second dodgy judgment, by declaring that, "this association could be due to chance."

These sweeping decisions allowed the authors to arrive at the questionable conclusion that, "There was a suggestion of increased ASD risk among children whose mothers received influenza vaccinations early in pregnancy (first trimester), although the association was insignificant after statistical correction for multiple comparisons." The researchers summed up with an acknowledgement of the uncertainty of their conclusion: "We believe that additional studies are warranted to further evaluate any potential associations between first-trimester maternal influenza vaccination and autism."

National media outlets universally missed that nuance. Journalists widely reported the study as a decisive exoneration of flu shots. NPR declared: Flu Shots Don't Increase Autism Risk In Pregnancy. Fox News‎ celebrated: Flu—or flu vaccine—in pregnancy not tied to autism in kids. The Scientist‎ headlined: Autism Not Linked to Flu or Flu Shot During Pregnancy, while the New York Daily News assured: No link between flu or flu vaccine in pregnancy and autism: study.

As the mainstream media celebrated, public health advocates and scholars cried "foul." Dr. James Lyons-Weiler, PhD, the CEO and director of the Institute for Pure and Applied Knowledge, and data manager of more than 100 biomedical research studies, told me that the author's "incorrect" and "unorthodox" application of the Bonferroni Correction in this circumstance risked the appearance that they were using improper methodologies to, "make an unwanted but statistically significant finding vanish in a sea of statistical wizardry."

Sander Greenland, professor of Statistics and Epidemiology at UCLA's School of Public Health and College of Letters and Science, agreed that the use of the Bonferroni Adjustment was inappropriate in this context. Greenland is among America's preeminent statisticians with more than 300 peer reviewed publications—two of which have been cited more than 500 times. He is editor of the Dictionary of Epidemiology.

Greenland said the research team's use of Bonferroni makes no sense "where there are finely correlated outcomes" and where the cost of a false negative is high—the possibly erroneous conclusion that first trimester flu shots are safe. (See at the end of the post Dr. Greenland's detailed explanation of the Bonferroni and why it was inappropriate.)

Greenland observes that "in a context like this, it's something that's usually called up, after the fact, when they get some significance like this, where they don't like it and they want to see if they can get rid of it that way. It's obvious why they used it. It makes the so-called significance go away and, of course, that's the goal. They're trying to make things go away…that's sort of a standard strategy now—by a large segment of the pharmaceutical experts that try to get rid of things. They didn't like the results and they jumped on it with the Bonferroni. It's not appropriate here." Greenland added, sympathetically, that the deception was probably not deliberate, "I don't think they think this out loud in their minds, it's just completely Freudian unconscious."

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