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Deadly Immunity
Robert F. Kennedy Jr.

Summary: When a study revealed that mercury in children's vaccines might have caused thousands of kids to develop autism, the U.S. government rushed to conceal the research to prevent parents from suing pharmaceutical companies that played a dubious role in this epidemic.

In June 2000, a group of scientists and senior government health officials gathered at the secluded Simpsonwood Conference Center. The meeting was convened by the Centers for Disease Control and Prevention (CDC) and held in Norcross, Georgia, near the wooded farmland by the Chattahoochee River, to ensure complete confidentiality. The CDC did not announce the meeting in advance, and only 52 people were privately invited. Attendees included senior officials from the CDC and the U.S. Food and Drug Administration (FDA), top vaccine experts from the World Health Organization in Geneva, and representatives from every major vaccine manufacturer, including GlaxoSmithKline, Merck, Wyeth, and Aventis Pasteur. CDC officials repeatedly reminded participants that all scientific data discussed were strictly "confidential": no documents could be photocopied or taken away after the meeting.

Federal officials and industry representatives met to discuss a troubling new study that raised alarming concerns about the safety of childhood vaccines. The study’s author was Tom Verstraeten, a CDC epidemiologist who had analyzed the agency’s massive database of medical records for 100,000 children. He found that thimerosal, a mercury-based preservative in vaccines, appeared to be responsible for a dramatic increase in autism and other neurological disorders among children. "I was actually stunned by what I saw," Verstraeten told the assembled participants at Simpsonwood. He presented preliminary findings showing a disturbing link between thimerosal and speech delays, attention deficit disorder, hyperactivity, and autism.

Since 1991, the CDC and FDA had recommended adding three vaccines containing mercury preservatives for very young infants—including some administered within hours of birth. Following this change, the incidence of autism in the U.S. skyrocketed by 15 times: from 1 in 2,500 children to 1 in 166.

Even for vaccine scientists and doctors accustomed to dealing with life-and-death issues daily, Tom’s findings were shocking. "You can play with this [data] all you want," said Dr. Bill Weil, an advisor to the American Academy of Pediatrics. The results were "statistically significant," noted Dr. Richard Johnston, an immunologist and pediatrician from the University of Colorado, who was particularly shaken as his grandson had been born earlier that morning. "My first reaction?" he said. "Forgive my personal bias here—I don’t want my grandson to get a thimerosal-containing vaccine until we know more about what’s going on."However, government officials and senior executives from pharmaceutical companies did not immediately take action to warn the public or halt the supply of vaccines containing thimerosal. Instead, they spent most of the next two days discussing how to conceal and destroy the source data of the study. According to meeting records obtained through the U.S. Freedom of Information Act (a law mandating government transparency), many attendees were more concerned about how disclosing the damaging effects of thimerosal would impact the bottom line of the vaccine industry.

"In any legal proceeding, we would be in a terrible position," said Dr. Robert Brent, a pediatrician from the Alfred I. duPont Hospital for Children in Delaware. "This is crucial evidence for the parents and lawyers who are already aggressively suing us." Dr. Bob Chen, head of vaccine safety at the CDC, remarked, "Fortunately, we’ve been able to keep this sensitive study under our control and out of the hands of those who are less responsible." Dr. Clements, a vaccine advisor for the World Health Organization, went so far as to declare that the study "should never have been conducted," warning that the findings "could be seized and misused by those with ulterior motives, and the organizers of this meeting would lose control. Therefore, the results must be handled with extreme caution."

In reality, the government has long proven itself more adept at covering up harm than protecting children’s health. The CDC decided to commission a new study from the Institute of Medicine to downplay the risks of thimerosal. Researchers were instructed to "rule out" any link between the chemical and autism. The agency also withheld Verstraeten’s findings, even though the study was originally slated for immediate publication. The CDC told other scientists that Verstraeten’s original database had been "lost," making it impossible to replicate the results. To evade FOIA requirements, the CDC transferred its massive vaccine records database to a private company, declaring the data off-limits to researchers. By the time Verstraeten finally published his study in 2003, he had taken a job at GlaxoSmithKline and obscured the connection between thimerosal and autism in his data.

Meanwhile, vaccine manufacturers began phasing out thimerosal-containing infant vaccines—but they continued selling mercury-laced vaccines until last year. The CDC and FDA also lent a hand to the industry by purchasing contaminated vaccines and exporting them to developing nations, while allowing pharmaceutical companies to keep using the preservative in some U.S. vaccines—including several pediatric flu shots and tetanus boosters for children as young as 11.

Pharmaceutical companies also received help from powerful lawmakers in Washington. Senate Majority Leader Bill Frist, who had received $873,000 in donations from the drug industry, worked tirelessly to shield vaccine makers from liability in the 4,200 lawsuits filed on behalf of injured children. On five separate occasions, Frist attempted to classify all government vaccine-related documents—including the Simpsonwood meeting records—as confidential. He also protected Eli Lilly, the developer of thimerosal, from being subpoenaed. In 2002, the day after the Homeland Security Act was introduced, Frist quietly inserted a provision dubbed the "Eli Lilly Protection Act" into the bill. Eli Lilly had contributed $10,000 to Frist’s campaign and purchased 5,000 copies of his book on bioterrorism. In 2003, Congress ultimately rejected Frist’s provision.But earlier this year, Frist inserted another proposal into the anti-terrorism bill, which denied compensation to children suffering from vaccine-related brain disorders. Frist's legislative assistant, Andy Olson, said, "These lawsuits are so massive that they would bankrupt vaccine manufacturers and drive them out of the market, ultimately limiting our ability to respond to bioterrorist attacks."

Even many conservatives were shocked by the government's efforts to cover up the dangers of thimerosal. Republican Congressman Dan Burton from Indiana, whose grandson was diagnosed with autism, oversaw a three-year investigation into thimerosal. "Vaccines containing thimerosal as a preservative are directly linked to the autism epidemic," he concluded in the final report of the House Government Reform Committee. "If the U.S. Food and Drug Administration had not been asleep at the wheel and had banned the injection of thimerosal—a known neurotoxin—without safety data, this epidemic could have been avoided." The committee stated that the FDA and other public health agencies failed to act because they were preoccupied with "institutional malfeasance to protect themselves" and "misplaced protection of the pharmaceutical industry."

The collusion between government health agencies and big pharmaceutical companies to hide the risks of thimerosal from the public is a chilling case of institutional arrogance, power, and greed. I was reluctantly drawn into this controversy. As a lawyer and an environmentalist who has worked for years on mercury toxicity, I frequently met with mothers of autistic children who firmly believed their children had been harmed by vaccines. Privately, I was skeptical. I didn’t yet know whether vaccines could be blamed as the sole cause of autism, and I certainly understood the government’s need to reassure parents that vaccinations are safe, as the eradication of deadly childhood diseases depends on it. I tended to agree with skeptics like Democratic Congressman Henry Waxman from California, who criticized his colleagues on the House Government Reform Committee for jumping to conclusions about the link between autism and vaccinations. "Why scare people about immunizations," Waxman pointed out at a hearing, "until we know the facts?"

However, after reading the transcripts of the Simpsonwood meeting, studying the latest scientific research, and discussing with many nationally renowned experts on mercury issues, I became convinced that the link between thimerosal and the epidemic of childhood neurological disorders is real. My own five children are part of the thimerosal generation—born between 1989 and 2003, they received large doses of mercury-laden vaccines. "Elementary schools are now filled with children who have neurological disorders or immune system damage," testified Patti White, a school nurse, to the House Government Reform Committee in 1999. "Vaccines were supposed to make us healthier; yet in my 25-year nursing career, I have never seen so many sick and damaged children. Something is very, very wrong with our children." Today, over 500,000 children suffer from autism, with pediatricians diagnosing 40,000 new cases each year. This disease was unknown until 1943. The first identified and diagnosed cases were 11 children born in 1931, just months after thimerosal was first added to infant vaccines.

Some skeptics dismiss the autism outbreak as caused by thimerosal-contaminated vaccines. They argue that the increase in cases is due to better diagnostics. This theory is untenable because the majority of autism cases are concentrated in a single generation of children."If this epidemic is rarely true in the past because diagnostic techniques were insufficient," said Dr. Boyd Haley, one of the world's leading authorities on mercury toxicity, "then why haven't the new diagnostic techniques found autism cases in people over 20?" Other researchers point out that the U.S. faces a greater cumulative "load" of mercury poisoning than ever before, from contaminated fish to dental fillings. Thimerosal in vaccines might just be the tip of the iceberg. This is certainly a phenomenon worth noting. The fact is, our children are exposed to much higher concentrations of mercury in vaccines than from other sources.

The most striking phenomenon is how many renowned American experts and institutions have long ignored or concealed adverse evidence about thimerosal. From the very beginning, scientific studies opposing mercury additives were abundant. The preservative containing ethylmercury, used to prevent fungal and bacterial growth in vaccines, is also a potent neurotoxin. Numerous studies show that mercury tends to accumulate in the brains of primates and other animals after vaccination, particularly in the developing brains of infants. In 1977, Russian research found that adults exposed to ethylmercury at concentrations much lower than those given to American children still suffered brain damage. Thus, Russia banned thimerosal in children's vaccines 20 years ago. Denmark, Austria, Japan, the UK, and all Scandinavian countries have since followed suit.

"You can't even fabricate a study showing thimerosal is safe," said Dr. Haley, who heads the chemistry department at the University of Kentucky. "It's fucking toxic. If you inject it into animals, their brains get sick. If you apply it to living tissue, the cells die. If you put it in a petri dish, the culture dies. Knowing these facts, if you hear someone say injecting mercury into a baby does no harm, you’d be absolutely shocked."

Internal documents reveal that Eli Lilly, the inventor of thimerosal, knew from the start that the product could harm—or even kill—animals and humans. In 1930, the company tested thimerosal on 22 meningitis patients, all of whom died within weeks. This fact was not reported in its study declaring thimerosal safe. In 1935, researchers from another vaccine manufacturer, Pittman-Moore, warned that Lilly’s claims about thimerosal’s safety "did not check with ours." Half the dogs injected with thimerosal-containing vaccines by Pittman fell ill, and the company’s lead researcher declared the preservative "unsatisfactory as a serum additive for dogs."

Over the following decades, adverse evidence against thimerosal continued to mount. During World War II, when the U.S. military used preservative-laden vaccines for soldiers, they required Lilly to label them as "toxic." In 1967, a study in Applied Microbiology found that thimerosal-containing vaccines could kill mice. Four years later, Lilly’s own research found its thimerosal "toxic to tissue cells" at concentrations 100 times weaker than those in a typical vaccine today. Despite this, the company continued to market thimerosal as "nontoxic" and used it as a primary antiseptic preservative. In 1977, ten infants in a Toronto hospital died after their umbilical cords were treated with a thimerosal-preserved antiseptic.In 1982, the U.S. FDA proposed banning over-the-counter drugs containing thimerosal, and by 1991, the agency considered prohibiting the use of mercury in animal vaccines. Tragically, that same year, the Centers for Disease Control and Prevention recommended that infants receive a series of mercury-contaminated vaccines. Newborns were to be vaccinated against hepatitis B within 24 hours of birth, and at two months old, infants would receive immunizations for Haemophilus influenzae type B, diphtheria, tetanus, and pertussis.

The manufacturing industry had long known that the additional recommended vaccines posed dangers. In the same year the CDC approved the new vaccines, Dr. Maurice Hilleman, one of the original developers of Merck’s vaccine program, warned that six-month-old children receiving vaccines would face dangerous mercury exposure. He recommended discontinuing thimerosal, "especially when used in infants and children," adding, "The best solution would be to distribute vaccines without added preservatives."

But for Merck and other pharmaceutical companies, the main obstacle was money. Thimerosal allowed the industry to package multiple doses of vaccines into a single vial, which required extra protection because they were more susceptible to contamination from repeated needle entries. Multi-dose vials cost half or even less than single-dose vials, enabling international agencies to distribute them more cheaply to impoverished regions to combat epidemic risks. Faced with these "cost considerations," Merck ignored Hilleman’s warning, and government officials continued pushing more thimerosal-containing vaccines for children. Before 1989, American preschoolers received only three vaccines—for polio, diphtheria, tetanus, pertussis, measles, mumps, and rubella. A decade later, due to federal agency recommendations, children entering first grade were given a total of 22 immunizations.

As the number of vaccines increased, autism rates skyrocketed among children. In the 1990s, 400,000 children injected with thimerosal-containing vaccines received unprecedented doses of mercury during their critical brain development stages. Despite overwhelming evidence of thimerosal’s dangers, no one seemed concerned enough to calculate the cumulative mercury doses in the expanding mandatory childhood vaccines. "Why did the FDA wait so long to start tallying cumulative mercury exposure?" asked Dr. Peter Patriarca, director of the FDA’s vaccine products division, in a 1999 email to the CDC. "Why didn’t the CDC and other advisory bodies perform these calculations as the childhood immunization schedule rapidly expanded?"

But by then, the damage was done. All vaccinated infants, including booster shots, received cumulative ethylmercury doses by six months of age that exceeded the EPA’s daily limit for methylmercury exposure (a related neurotoxin) by more than 187 times. Although the vaccine industry insisted ethylmercury posed little danger because it was quickly broken down and excreted, some studies—including one published in April by the National Institutes of Health—suggested ethylmercury was actually more toxic to developing brains and lingered longer in the brain than methylmercury.

Officials responsible for child immunization maintained that more vaccines were necessary to protect infants from disease and that thimerosal remained essential in developing countries. They often claimed that the UN could not afford single-dose vials that didn’t require preservatives.One of the CDC's chief vaccine advisors, Dr. Paul Offit, told me: "I think if we really have a flu pandemic—and we certainly will in the next 20 years, because we always do—there's no way to immunize the 28 million people on Earth with single-dose vials. We must have multi-dose vials."

However, while public health officials may have made decisions with good intentions, many members of the CDC advisory committee who supported additional vaccines had close ties to the pharmaceutical industry. Dr. Sam Katz, the committee's chairman, was a paid consultant for several major vaccine manufacturers. He shared the patent for the measles vaccine with Merck, which also produced the hepatitis B vaccine. Dr. Neal Halsey, another committee member, had worked as a researcher for vaccine companies and received compensation from Abbott Laboratories for his contributions to hepatitis B vaccine research.

In fact, such conflicts of interest are common in the tight-knit world of vaccine research and production. Congressman Burton stated that the CDC "frequently allows scientists with clear conflicts of interest to advise advisory committees on new vaccines," even when they have "personal stakes in the products and companies under review—when they are supposed to provide unbiased oversight." The U.S. House Committee on Government Reform found that four out of eight CDC advisors who approved the rotavirus vaccine containing thimerosal had financial ties to pharmaceutical companies developing different versions of the vaccine.

Offit, who shares a vaccine patent, admitted to me that he "would make money" if his vote led to the approval of a product sold on the market. But he dismissed my concerns that a scientist's direct financial interest in a CDC-approved recommendation could influence their judgment. "It's not a conflict for me," he insisted. "I'm just informed within this decision-making system, not corrupted by it. When I sit around that conference table, my only intent is to make recommendations that best benefit the children of this country. It's insulting to suggest that doctors and public health officials would make decisions harmful to children's safety because of financial ties to drug companies. That just doesn’t happen."

Other vaccine scientists and regulators gave me similar assurances of credibility. Like Offit, they see themselves as enlightened guardians of children's health, proud of their "partnerships" with pharmaceutical companies and immune to personal financial temptations. They describe themselves as surrounded by unreasonable anti-vaccine activists who endanger children's health. They often resent questions from laypeople. "Science," Offit said, "is best left to the scientists."

Nevertheless, some government officials remain deeply troubled by the apparent conflicts of interest in vaccine regulation. In his 1999 email to CDC leadership, the FDA's Paul Patriarca criticized federal regulators for failing to adequately examine the dangers posed by increasing infant vaccines. "I’m not sure there’s a simple way to dispel the notion that the FDA, CDC, and vaccination policy agencies may have been asleep at the wheel regarding thimerosal," Patriarca wrote. "The close ties between regulators and the pharmaceutical industry," he added, "will also raise more questions about the aggressive recommendations from advisory bodies for childhood vaccines containing thimerosal."For years, federal regulators and government scientists may have had excuses for failing to grasp the potential risks of thimerosal, but no one could claim ignorance after the secret Simpsonwood meeting. Unfortunately, instead of conducting more research to test the causes of autism and other forms of brain damage, the Centers for Disease Control and Prevention played politics with science. The agency handed over its childhood vaccine database—developed primarily at taxpayer expense—to a private entity, America’s Health Insurance Plans, ensuring it could not be used for further research. It also instructed the Institute of Medicine, an advisory body under the National Academy of Sciences, to produce a study dismissing the link between thimerosal and brain disorders. Dr. Marie McCormick, who chaired the Institute of Medicine’s Immunization Safety Review Committee, made it clear at their first meeting in January 2001 that the CDC "wants us to declare, these things are pretty safe." "We are not ever going to come down that [autism] is a true side effect" of thimerosal in vaccines, predicted Kathleen Stratton, the committee’s lead staffer, according to meeting transcripts. The Institute of Medicine would conclude that the evidence was "inadequate to accept or reject a causal relationship" between thimerosal and autism, she added, noting this was "the outcome Walter wanted." Here, "Walter" referred to Dr. Walter Orenstein, director of the National Immunization Program.

For those who had dedicated their lives to promoting vaccination, exposing thimerosal’s side effects risked undermining their life’s work. "We’ve got a dragon by the tail here," said another committee member, Michael Kaback. "The more negative our reviews are, the fewer people will get vaccinated. We know the outcome will be that we’re stuck in a trap. Figuring out how to escape it, I think, is key."

Even in public, federal officials made it clear that their primary goal in studying thimerosal was to dispel public doubts about vaccines. "Four studies are already underway to rule out any link between autism and thimerosal," Dr. Gordon Douglas, then head of strategic vaccine research planning at the National Institutes of Health, assured attendees at a Princeton University conference in May 2001. "To counter the harmful claims that [measles] vaccines cause autism, we need more research and outreach to reassure parents about vaccine safety," he said. Douglas had previously served as Merck’s vaccine chief, where he ignored warnings about thimerosal’s risks.

Last May, the Institute of Medicine under the National Academy of Sciences issued its final report. Its conclusion: no demonstrable link exists between autism and thimerosal in vaccines. The report did not review the vast body of literature describing thimerosal’s toxicity but instead relied on four epidemiologic studies with catastrophic flaws. These studies examined European countries where children received far smaller doses of thimerosal than American children. It also cited a revised version of Verstraeten’s study, published in Pediatrics, which had been manipulated to weaken the link between thimerosal and autism. The new study included children too young to be diagnosed with autism while ignoring others who showed clear signs of the disorder. The Institute of Medicine declared the debate over—in an uncharacteristic move for a scientific body—by recommending no further research.

The report may have satisfied the CDC, but it convinced no one else.Republican Congressman Weldon David of Florida, a physician serving on the House Government Reform Committee, refuted the conclusions of the Institute of Medicine, calling them a "fatal flaw" based on "poorly designed" studies that relied on a handful of research papers and failed to represent "all existing scientific and medical research." "CDC officials are actually the least interested in seeking an honest truth," Weldon told me, because "a link between vaccines and autism would force them to admit that their policies have irreparably harmed thousands of children. Who would want such a conclusion that discredits themselves?"

Under pressure from parents and a minority of the Institute of Medicine’s own members in Congress, the Institute reluctantly convened a second committee composed of scientists from different fields to investigate. In February of this year, the findings of the new committee were starkly different from the first. This committee criticized the previous one for lacking transparency and urged the CDC to make its vaccine database publicly accessible.

But so far, only two scientists have managed to access the CDC’s vaccine database. Dr. Mark, president of the American Genetics Center, and his son David spent a year fighting to obtain the CDC’s medical records. Since August 2002, when the agency was pressured by Congress to release the data, the Gales have completed six studies showing a strong correlation between thimerosal and neurological damage in children. One study compared the cumulative mercury doses received by children born between 1981–1985 and those born between 1990–1996, finding a "highly significant relationship" between autism and vaccines. Another study found that children who received higher doses of thimerosal-containing vaccines were three times more likely to be diagnosed with autism, speech disorders, and mental retardation. A forthcoming study indicates that autism rates have declined since thimerosal was largely removed from vaccines.

While the federal government has worked to prevent scientists from studying vaccines, others have intensified research into the vaccine-autism link. In April, journalist Dan Ted conducted his own intriguing study: searching for children who had not been exposed to mercury in vaccines—a group typically used as a "control" in scientific experiments. Ted investigated the Amish community in Lancaster County, Pennsylvania, where parents refuse to vaccinate their infants. Based on the national autism rate, Ted calculated that there should be 130 autistic Amish children. Yet he found only four. One had been exposed to high doses of mercury from a power plant leak. The other three—including one child from outside the Amish community—had received vaccines.

At the state level, many officials have also scrutinized thimerosal closely. While the Institute of Medicine was busy downplaying the risks, the Iowa legislature meticulously reviewed all available scientific and biological data. "After three years of review, I am convinced there is credible research showing a link between mercury and increased autism rates," said Republican State Senator Ken Veenstra, who led the investigation. "In fact, Iowa’s 700% rise in autism began in the 1990s, precisely when more vaccines were added to children’s immunization schedules. That alone is conclusive evidence." Last year, Iowa became the first state to ban mercury-containing vaccines. California followed suit. Similar bans are currently under consideration in 32 other states.

But instead of following suit, the FDA continues to allow manufacturers to use thimerosal in over-the-counter drugs, steroids, and injectable collagen.Even more shockingly, the government continues to supply thimerosal-containing vaccines to developing countries—some of which are now experiencing a sudden surge in autism cases. In China, where the disease was virtually unknown before U.S. drug manufacturers introduced thimerosal in 1999, news reports now indicate there are more than 1.8 million autistic children. While reliable statistics are hard to come by, autism rates are also soaring in other developing nations currently using thimerosal-preserved vaccines, including India, Argentina, and Nicaragua. The World Health Organization continues to insist thimerosal is safe, but it acknowledges that a review of its potential link to neurological disorders is underway.

I devoted significant time to studying this issue because I believe it represents an American moral crisis that must be addressed. If there is indeed evidence that our public health authorities knowingly allowed the pharmaceutical industry to poison an entire generation of American children, their actions would undoubtedly constitute one of the greatest scandals in the history of American medicine. "The CDC is a rogue, incompetent agency," said Mark Blaxill, vice president of a nonprofit focused on mercury-based drug safety. "The damage caused by vaccine contamination is immense—far worse than asbestos, tobacco, or anything else you can think of." The harm to our nation, as well as to global efforts to eradicate infectious diseases, is incalculable. If Third World nations come to believe that America's most touted foreign aid initiative is poisoning their children with vaccines, it's not hard to imagine how our adversaries might exploit this. Vaccine scientists and researchers—many of whom are sincere, even idealistic—are caught between helping drug companies obscure the true science of thimerosal and advancing the noble goal of preventing disease pandemics among children in developing nations. They are gravely misguided. Their disgraceful stance on thimerosal will come back to haunt our nation and the world's poorest populations in terrifying ways.

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