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Metals Debris Found in Vaccine Supply

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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A Letter From Robert F. Kennedy, Jr. and Robert De Niro to American Journalists

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.

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Yale University Study Shows Association Between Vaccines and Brain Disorders

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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CDC Knew Its Vaccine Program Was Exposing Children to Dangerous Mercury Levels Since 1999

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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Mounting Evidence Links Lead, Mercury and Arsenic to Autism

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.

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Bill Nye and Netflix Team Up to 'Save the World'

With a rough 2016 officially behind us, and a foreboding 2017 ahead, maybe we all need a good dose of 1990's nostalgia. This Spring, Bill Nye will make his long-awaited return to our screens with his new Netflix show, Bill Nye Saves the World.

The Science Guy and his band of correspondents—model Karlie Kloss, Xploration Outer Space host Emily Calandrelli, comedians Joanna Hausmannm and Nazeem Hussain, and Veritasium host Derek Muller—will explore some of the most complex scientific topics of the day, from climate change, vaccines and genetically modified organisms (GMOs).

While Netflix first announced the show in late August, Nye's comeback seems all the more fitting with Donald Trump's presidential inauguration this Jan. 20.

"Each episode will tackle a topic from a scientific point of view, dispelling myths, and refuting anti-scientific claims that may be espoused by politicians, religious leaders or titans of industry," Netflix stated in a press release.

Trump, as any EcoWatch reader knows, is just about as anti-science as it gets. The president-elect has plans to withdraw from the Paris climate agreement, undo President Obama's signature Clean Power Plan and other environmental initiatives, and has nominated an entire cabinet of fossil fuel "puppets" and executives.

Nye came to fame in the 1990s as the host and creator of Bill Nye the Science Guy. The bowtie-wearing educator taught his young audience about the joys and importance of science and engineering.

We doubt that Trump will be streaming the new show, but Nye does intend to appeal to a wide audience.

"Since the start of the Science Guy show, I've been on a mission to change the world by getting people everywhere excited about the fundamental ideas in science," he said in the press release.

"Today, I'm excited to be working with Netflix on a new show, where we'll discuss the complex scientific issues facing us today, with episodes on vaccinations, genetically modified foods and climate change," he added. "With the right science and good writing, we'll do our best to enlighten and entertain our audience. And, perhaps we'll change the world a little."

Since Science Guy came off the air in 1998 after five seasons, Nye has made numerous appearances on television shows and online videos as a science commentator and outspoken environmental advocate.

Earlier this year, the educational icon famously bet climate change denier Marc Morano $20,000 that 2016 will be among the hottest on record and that this decade will be record hot. Morano turned down the bet, claiming that it's "obvious" that scientific data will show warming, implying that the data would be doctored.

2016, of course, is officially the hottest year ever recorded, scientists have determined.

Nye also made waves in March 2015 when he came out in favor of GMOs, following a visit with Monsanto. Before that, Nye had major concerns about the safety of GMOs.

In an interview with Huffington Post Live, Nye explained that "GMOs are not inherently bad. We are able to feed 7.2 billion people, which a century and a half ago you could barely feed 1.5 billion people and [it's] largely because of the success of modern farming."

However, Nye cautioned that introducing new organisms into the ecosystem can have "unintended consequences."

"My take on it now is genetically modified food is actually, in general—genetically modified plants, in general—are not only not harmful, they're actually a great benefit. However, you can't just go planting enormous monocultures and killing everything and expect the ecosystems to take it," he said.

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Early Pregnancy Flu Shots: New Research Hints of Autism Link

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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Mercury, Vaccines and the CDC's Worst Nightmare

By Rita Shreffler

For over three decades, Robert F. Kennedy, Jr. has been one of the world's leading environmental advocates. He is the founder and president of Waterkeeper Alliance, the umbrella group for 300 local waterkeeper organizations, in 34 countries, that track down and sue polluters. Under his leadership, Waterkeeper has grown to become the world's largest clean water advocacy organization.

Around 2005, parents of vaccine-injured children started encountering Kennedy's speeches and writings about the toxic mercury-based preservative thimerosal. They embraced new hope that this environmental champion would finally expose the truth about vaccine injury and win justice for injured children. Kennedy is known for his fierce and relentless brand of environmental activism and his advocacy for transparent government and rigorous science. He is now applying his tenacious energies and sophisticated strategies to exposing the fraud and corruption within the Center for Disease Control and Prevention (CDC) and the pharmaceutical industry. Last month, he launched his new non-profit, the World Mercury Project, with vaccine safety advocates Lyn Redwood and Laura Bono, legends themselves among parents of vaccine-injured children. Autism File executive editor Rita Shreffler spoke with Kennedy about CDC corruption, pharmaceutical industry greed, media malpractice and his vision for the World Mercury Project.

(Left to Right) Laura Bono, Robert F. Kennedy, Jr. and Lyn Redwood are leading the charge against toxic mercury exposures.

Rita Shreffler: How did you first get involved in the autism/vaccine controversy?

Robert F. Kennedy: I was dragged kicking and screaming into this brawl. By the early 2000s, I was fighting multiple lawsuits on behalf of Riverkeeper and Waterkeeper against coal-fired power plants. I was touring the country speaking about, among other things, the dangers of mercury emissions, which, by then, had contaminated virtually every fresh water fish in America. Following many of these appearances, mothers would approach me. Their tone was always respectful but mildly scolding. They said that if I was serious about eliminating the perils of mercury, I needed to look at thimerosal. Vaccines, they claimed, were the biggest vector for mercury exposure in children. I really didn't want to get involved because vaccines were pretty remote from my wheelhouse. I'd always been pro-vaccine. I had all my kids vaccinated and got my annual flu shot every year. But, I was impressed by these women. Many of them were professionals: doctors, lawyers, scientists, nurses and pharmacists. They were overwhelmingly solid, well-educated, extraordinarily well-informed, rational and persuasive.

Robert F. Kennedy, Jr. participated in a panel discussion following the United Nations screening of Trace Amounts on August 27, 2015.Mary Holland

RS: Was there a particular one of these mothers who finally got you to take the bait?

RFK, JR: Yeah, my brother Max's wife, Vicky Strauss Kennedy, introduced me to a psychologist named Sarah Bridges. Her son Porter was vaccine-injured and later diagnosed with autism. After an eight year legal battle, she had finally received compensation from the vaccine court, which acknowledged that Porter got his autism, seizures and brain damage from thimerosal and pertussis vaccines. She persuaded me to start looking into the science.

RS: That was a daunting request!

RFK, JR: I have always loved science and I'm comfortable reading it. By then, I'd handled many hundreds of environmental cases. Almost all of them involved scientific controversies. When I started reading about thimerosal, I was dumbstruck by the contrast between the scientific reality and the media consensus. All the network news anchors and television doctors were assuring the public that there was not a single study that suggested thimerosal was unsafe or that it could cause autism. After a short time on PubMed, I'd identified many dozens of studies suggesting that thimerosal causes autism and a rich library of peer-reviewed literature—more than 400 published studies—attesting to its deadly toxicity and its causal connection to a long inventory of neurological injuries and organ damage.

RS: What do we know about thimerosal safety testing?

RFK, JR: First of all, vaccines are not subject to the safety rigors undergone by other pharmaceuticals in the FDA approval process. There are no large scale, double-blind, placebo-controlled studies. And, in the one 1930 human study of thimerosal that predated its use in vaccines, all the subjects injected with thimerosal died. In 2004, an FDA official acknowledged in testimony before a Congressional committee, that no government or privately funded study has ever demonstrated thimerosal's safety. On the other hand, there is plenty of science suggesting that thimerosal is NOT safe. Several hundred studies available on PubMed link thimerosal exposure to the neurodevelopmental and immune system diseases that are now epidemic in the generation of American children born after the CDC dramatically increased childhood thimerosal exposure starting in 1988.

My book, Thimerosal—Let the Science Speak, summarizes these studies. The scientific literature inculpates increased thimerosal exposure as a culprit in the explosion of ADD, ADHD, speech delay, narcolepsy, SIDS, ASD, seizure disorder, tics and anaphylaxis, including asthma and food allergies. According to the CDC, one in six American children—the so called "thimerosal generation"—now suffers from a developmental disability. We have published a compendium of 80 published, peer-reviewed studies that strongly suggest a link between thimerosal exposure and autism.

RS: The CDC started adding to the vaccine schedule in the late 1980s and all these diseases, including autism, began spiking among kids in the mid-1990s. That's when parents started seeing perfectly healthy children regress into autism after receiving their vaccines.

RFK, JR: Yeah. A rising chorus of complaints from parents and pediatricians linked the new thimerosal-heavy vaccine schedule to an explosion in autism. In response, the CDC, in 1999, commissioned an in-house Belgian researcher, Thomas Verstraeten, to study the Vaccine Safety Datalink, the largest American repository of childhood vaccine and health records, collected by HMOs. The HMO data clearly showed that the massive mercury doses in the newly expanded vaccine schedule were causing runaway epidemics of neurological disorders—ADD, ADHD, speech delay, sleep disorders, tics and autism among America's children. Verstraeten's original analysis of those datasets found that thimerosal exposures increased autism risk by 760%. The CDC now knew the cause of the autism epidemic.

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