Autism and Mercury

Illustration by Ed Sorel
Deadly Immunity
Robert F. Kennedy Jr. investigates the government cover-up of a mercury/autism scandal
By ROBERT F. KENNEDY JR.

A child in Beijing gets a meningitis shot
Kennedy Report Sparks Controversy
Intense reaction from medical establishment and leading news organizations
By THE EDITORS

TheBeachers: A photographic essay of the life at Coon Lake Beach by photographer Peter Dennis. See the Forest Lake Press article here.

In June 2000, a group of top government scientists and health officials gathered for a meeting at the isolated Simpsonwood conference center in Norcross, Georgia. Convened by the Centers for Disease Control and Prevention, the meeting was held at this Methodist retreat center, nestled in wooded farmland next to the Chattahoochee River, to ensure complete secrecy. The agency had issued no public announcement of the session -- only private invitations to fifty-two attendees. There were high-level officials from the CDC and the Food and Drug Administration, the top vaccine specialist from the World Health Organization in Geneva and representatives of every major vaccine manufacturer, including GlaxoSmithKline, Merck, Wyeth and Aventis Pasteur. All of the scientific data under discussion, CDC officials repeatedly reminded the participants, was strictly "embargoed." There would be no making photocopies of documents, no taking papers with them when they left.

The federal officials and industry representatives had assembled to discuss a disturbing new study that raised alarming questions about the safety of a host of common childhood vaccines administered to infants and young children. According to a CDC epidemiologist named Tom Verstraeten, who had analyzed the agency's massive database containing the medical records of 100,000 children, a mercury-based preservative in the vaccines -- thimerosal -- appeared to be responsible for a dramatic increase in autism and a host of other neurological disorders among children. "I was actually stunned by what I saw," Verstraeten told those assembled at Simpsonwood, citing the staggering number of earlier studies that indicate a link between thimerosal and speech delays, attention-deficit disorder, hyperactivity and autism. Since 1991, when the CDC and the FDA had recommended that three additional vaccines laced with the preservative be given to extremely young infants -- in one case, within hours of birth -- the estimated number of cases of autism had increased fifteenfold, from one in every 2,500 children to one in 166 children.

Even for scientists and doctors accustomed to confronting issues of life and death, the findings were frightening. "You can play with this all you want," Dr. Bill Weil, a consultant for the American Academy of Pediatrics, told the group. The results "are statistically significant." Dr. Richard Johnston, an immunologist and pediatrician from the University of Colorado whose grandson had been born early on the morning of the meeting's first day, was even more alarmed. "My gut feeling?" he said. "Forgive this personal comment -- I do not want my grandson to get a thimerosal-containing vaccine until we know better what is going on."

But instead of taking immediate steps to alert the public and rid the vaccine supply of thimerosal, the officials and executives at Simpsonwood spent most of the next two days discussing how to cover up the damaging data. According to transcripts obtained under the Freedom of Information Act, many at the meeting were concerned about how the damaging revelations about thimerosal would affect the vaccine industry's bottom line. "We are in a bad position from the standpoint of defending any lawsuits," said Dr. Robert Brent, a pediatrician at the Alfred I. duPont Hospital for Children in Delaware. "This will be a resource to our very busy plaintiff attorneys in this country." Dr. Bob Chen, head of vaccine safety for the CDC, expressed relief that "given the sensitivity of the information, we have been able to keep it out of the hands of, let's say, less responsible hands." Dr. John Clements, vaccines advisor at the World Health Organization, declared that "perhaps this study should not have been done at all." He added that "the research results have to be handled," warning that the study "will be taken by others and will be used in other ways beyond the control of this group."

In fact, the government has proved to be far more adept at handling the damage than at protecting children's health. The CDC paid the Institute of Medicine to conduct a new study to whitewash the risks of thimerosal, ordering researchers to "rule out" the chemical's link to autism. It withheld Verstraeten's findings, even though they had been slated for immediate publication, and told other scientists that his original data had been "lost" and could not be replicated. And to thwart the Freedom of Information Act, it handed its giant database of vaccine records over to a private company, declaring it off-limits to researchers. By the time Verstraeten finally published his study in 2003, he had gone to work for GlaxoSmithKline and reworked his data to bury the link between thimerosal and autism.

Vaccine manufacturers had already begun to phase thimerosal out of injections given to American infants -- but they continued to sell off their mercury-based supplies of vaccines until last year. The CDC and FDA gave them a hand, buying up the tainted vaccines for export to developing countries and allowing drug companies to continue using the preservative in some American vaccines -- including several pediatric flu shots as well as tetanus boosters routinely given to eleven-year-olds.

The drug companies are also getting help from powerful lawmakers in Washington. Senate Majority Leader Bill Frist, who has received $873,000 in contributions from the pharmaceutical industry, has been working to immunize vaccine makers from liability in 4,200 lawsuits that have been filed by the parents of injured children. On five separate occasions, Frist has tried to seal all of the government's vaccine-related documents -- including the Simpsonwood transcripts -- and shield Eli Lilly, the developer of thimerosal, from subpoenas. In 2002, the day after Frist quietly slipped a rider known as the "Eli Lilly Protection Act" into a homeland security bill, the company contributed $10,000 to his campaign and bought 5,000 copies of his book on bioterrorism. The measure was repealed by Congress in 2003 -- but earlier this year, Frist slipped another provision into an anti-terrorism bill that would deny compensation to children suffering from vaccine-related brain disorders. "The lawsuits are of such magnitude that they could put vaccine producers out of business and limit our capacity to deal with a biological attack by terrorists," says Andy Olsen, a legislative assistant to Frist.

Even many conservatives are shocked by the government's effort to cover up the dangers of thimerosal. Rep. Dan Burton, a Republican from Indiana, oversaw a three-year investigation of thimerosal after his grandson was diagnosed with autism. "Thimerosal used as a preservative in vaccines is directly related to the autism epidemic," his House Government Reform Committee concluded in its final report. "This epidemic in all probability may have been prevented or curtailed had the FDA not been asleep at the switch regarding a lack of safety data regarding injected thimerosal, a known neurotoxin." The FDA and other public-health agencies failed to act, the committee added, out of "institutional malfeasance for self protection" and "misplaced protectionism of the pharmaceutical industry."

The story of how government health agencies colluded with Big Pharma to hide the risks of thimerosal from the public is a chilling case study of institutional arrogance, power and greed. I was drawn into the controversy only reluctantly. As an attorney and environmentalist who has spent years working on issues of mercury toxicity, I frequently met mothers of autistic children who were absolutely convinced that their kids had been injured by vaccines. Privately, I was skeptical.

I doubted that autism could be blamed on a single source, and I certainly understood the government's need to reassure parents that vaccinations are safe; the eradication of deadly childhood diseases depends on it. I tended to agree with skeptics like Rep. Henry Waxman, a Democrat from California, who criticized his colleagues on the House Government Reform Committee for leaping to conclusions about autism and vaccinations. "Why should we scare people about immunization," Waxman pointed out at one hearing, "until we know the facts?"

It was only after reading the Simpsonwood transcripts, studying the leading scientific research and talking with many of the nation's pre-eminent authorities on mercury that I became convinced that the link between thimerosal and the epidemic of childhood neurological disorders is real. Five of my own children are members of the Thimerosal Generation -- those born between 1989 and 2003 -- who received heavy doses of mercury from vaccines. "The elementary grades are overwhelmed with children who have symptoms of neurological or immune-system damage," Patti White, a school nurse, told the House Government Reform Committee in 1999. "Vaccines are supposed to be making us healthier; however, in twenty-five years of nursing I have never seen so many damaged, sick kids. Something very, very wrong is happening to our children."

More than 500,000 kids currently suffer from autism, and pediatricians diagnose more than 40,000 new cases every year. The disease was unknown until 1943, when it was identified and diagnosed among eleven children born in the months after thimerosal was first added to baby vaccines in 1931.
Some skeptics dispute that the rise in autism is caused by thimerosal-tainted vaccinations. They argue that the increase is a result of better diagnosis -- a theory that seems questionable at best, given that most of the new cases of autism are clustered within a single generation of children. "If the epidemic is truly an artifact of poor diagnosis," scoffs Dr. Boyd Haley, one of the world's authorities on mercury toxicity, "then where are all the twenty-year-old autistics?" Other researchers point out that Americans are exposed to a greater cumulative "load" of mercury than ever before, from contaminated fish to dental fillings, and suggest that thimerosal in vaccines may be only part of a much larger problem. It's a concern that certainly deserves far more attention than it has received -- but it overlooks the fact that the mercury concentrations in vaccines dwarf other sources of exposure to our children.
What is most striking is the lengths to which many of the leading detectives have gone to ignore -- and cover up -- the evidence against thimerosal. From the very beginning, the scientific case against the mercury additive has been overwhelming. The preservative, which is used to stem fungi and bacterial growth in vaccines, contains ethylmercury, a potent neurotoxin. Truckloads of studies have shown that mercury tends to accumulate in the brains of primates and other animals after they are injected with vaccines -- and that the developing brains of infants are particularly susceptible. In 1977, a Russian study found that adults exposed to much lower concentrations of ethylmercury than those given to American children still suffered brain damage years later. Russia banned thimerosal from children's vaccines twenty years ago, and Denmark, Austria, Japan, Great Britain and all the Scandinavian countries have since followed suit.

"You couldn't even construct a study that shows thimerosal is safe," says Haley, who heads the chemistry department at the University of Kentucky. "It's just too darn toxic. If you inject thimerosal into an animal, its brain will sicken. If you apply it to living tissue, the cells die. If you put it in a petri dish, the culture dies. Knowing these things, it would be shocking if one could inject it into an infant without causing damage."

Internal documents reveal that Eli Lilly, which first developed thimerosal, knew from the start that its product could cause damage -- and even death -- in both animals and humans. In 1930, the company tested thimerosal by administering it to twenty-two patients with terminal meningitis, all of whom died within weeks of being injected -- a fact Lilly didn't bother to report in its study declaring thimerosal safe. In 1935, researchers at another vaccine manufacturer, Pittman-Moore, warned Lilly that its claims about thimerosal's safety "did not check with ours." Half the dogs Pittman injected with thimerosal-based vaccines became sick, leading researchers there to declare the preservative "unsatisfactory as a serum intended for use on dogs."
In the decades that followed, the evidence against thimerosal continued to mount. During the Second World War, when the Department of Defense used the preservative in vaccines on soldiers, it required Lilly to label it "poison." In 1967, a study in Applied Microbiology found that thimerosal killed mice when added to injected vaccines. Four years later, Lilly's own studies discerned that thimerosal was "toxic to tissue cells" in concentrations as low as one part per million -- 100 times weaker than the concentration in a typical vaccine. Even so, the company continued to promote thimerosal as "nontoxic" and also incorporated it into topical disinfectants. In 1977, ten babies at a Toronto hospital died when an antiseptic preserved with thimerosal was dabbed onto their umbilical cords.

In 1982, the FDA proposed a ban on over-the-counter products that contained thimerosal, and in 1991 the agency considered banning it from animal vaccines. But tragically, that same year, the CDC recommended that infants be injected with a series of mercury-laced vaccines. Newborns would be vaccinated for hepatitis B within twenty-four hours of birth, and two-month-old infants would be immunized for haemophilus influenzae B and diphtheria-tetanus-pertussis.

The drug industry knew the additional vaccines posed a danger. The same year that the CDC approved the new vaccines, Dr. Maurice Hilleman, one of the fathers of Merck's vaccine programs, warned the company that six-month-olds who were administered the shots would suffer dangerous exposure to mercury. He recommended that thimerosal be discontinued, "especially when used on infants and children," noting that the industry knew of nontoxic alternatives. "The best way to go," he added, "is to switch to dispensing the actual vaccines without adding preservatives."
For Merck and other drug companies, however, the obstacle was money. Thimerosal enables the pharmaceutical industry to package vaccines in vials that contain multiple doses, which require additional protection because they are more easily contaminated by multiple needle entries. The larger vials cost half as much to produce as smaller, single-dose vials, making it cheaper for international agencies to distribute them to impoverished regions at risk of epidemics. Faced with this "cost consideration," Merck ignored Hilleman's warnings, and government officials continued to push more and more thimerosal-based vaccines for children. Before 1989, American preschoolers received eleven vaccinations -- for polio, diphtheria-tetanus-pertussis and measles-mumps-rubella. A decade later, thanks to federal recommendations, children were receiving a total of twenty-two immunizations by the time they reached first grade.

As the number of vaccines increased, the rate of autism among children exploded. During the 1990s, 40 million children were injected with thimerosal-based vaccines, receiving unprecedented levels of mercury during a period critical for brain development. Despite the well-documented dangers of thimerosal, it appears that no one bothered to add up the cumulative dose of mercury that children would receive from the mandated vaccines. "What took the FDA so long to do the calculations?" Peter Patriarca, director of viral products for the agency, asked in an e-mail to the CDC in 1999. "Why didn't CDC and the advisory bodies do these calculations when they rapidly expanded the childhood immunization schedule?"
But by that time, the damage was done. At two months, when the infant brain is still at a critical stage of development, infants routinely received three inoculations that contained a total of 62.5 micrograms of ethylmercury -- a level 99 times greater than the EPA's limit for daily exposure to methylmercury, a related neurotoxin. Although the vaccine industry insists that ethylmercury poses little danger because it breaks down rapidly and is removed by the body, several studies -- including one published in April by the National Institutes of Health -- suggest that ethylmercury is actually more toxic to developing brains and stays in the brain longer than methylmercury.

Officials responsible for childhood immunizations insist that the additional vaccines were necessary to protect infants from disease and that thimerosal is still essential in developing nations, which, they often claim, cannot afford the single-dose vials that don't require a preservative. Dr. Paul Offit, one of CDC's top vaccine advisers, told me, "I think if we really have an influenza pandemic -- and certainly we will in the next twenty years, because we always do -- there's no way on God's earth that we immunize 280 million people with single-dose vials. There has to be multidose vials."
But while public-health officials may have been well-intentioned, many of those on the CDC advisory committee who backed the additional vaccines had close ties to the industry. Dr. Sam Katz, the committee's chair, was a paid consultant for most of the major vaccine makers and was part of a team that developed the measles vaccine and brought it to licensure in 1963. Dr. Neal Halsey, another committee member, worked as a researcher for the vaccine companies and received honoraria from Abbott Labs for his research on the hepatitis B vaccine.

Indeed, in the tight circle of scientists who work on vaccines, such conflicts of interest are common. Rep. Burton says that the CDC "routinely allows scientists with blatant conflicts of interest to serve on intellectual advisory committees that make recommendations on new vaccines," even though they have "interests in the products and companies for which they are supposed to be providing unbiased oversight." The House Government Reform Committee discovered that four of the eight CDC advisers who approved guidelines for a rotavirus vaccine "had financial ties to the pharmaceutical companies that were developing different versions of the vaccine."

Offit, who shares a patent on one of the vaccines, acknowledged to me that he "would make money" if his vote eventually leads to a marketable product. But he dismissed my suggestion that a scientist's direct financial stake in CDC approval might bias his judgment. "It provides no conflict for me," he insists. "I have simply been informed by the process, not corrupted by it. When I sat around that table, my sole intent was trying to make recommendations that best benefited the children in this country. It's offensive to say that physicians and public-health people are in the pocket of industry and thus are making decisions that they know are unsafe for children. It's just not the way it works."

Other vaccine scientists and regulators gave me similar assurances. Like Offit, they view themselves as enlightened guardians of children's health, proud of their "partnerships" with pharmaceutical companies, immune to the seductions of personal profit, besieged by irrational activists whose anti-vaccine campaigns are endangering children's health. They are often resentful of questioning. "Science," says Offit, "is best left to scientists."
Still, some government officials were alarmed by the apparent conflicts of interest. In his e-mail to CDC administrators in 1999, Paul Patriarca of the FDA blasted federal regulators for failing to adequately scrutinize the danger posed by the added baby vaccines. "I'm not sure there will be an easy way out of the potential perception that the FDA, CDC and immunization-policy bodies may have been asleep at the switch re: thimerosal until now," Patriarca wrote. The close ties between regulatory officials and the pharmaceutical industry, he added, "will also raise questions about various advisory bodies regarding aggressive recommendations for use" of thimerosal in child vaccines.

If federal regulators and government scientists failed to grasp the potential risks of thimerosal over the years, no one could claim ignorance after the secret meeting at Simpsonwood. But rather than conduct more studies to test the link to autism and other forms of brain damage, the CDC placed politics over science. The agency turned its database on childhood vaccines -- which had been developed largely at taxpayer expense -- over to a private agency, America's Health Insurance Plans, ensuring that it could not be used for additional research. It also instructed the Institute of Medicine, an advisory organization that is part of the National Academy of Sciences, to produce a study debunking the link between thimerosal and brain disorders. The CDC "wants us to declare, well, that these things are pretty safe," Dr. Marie McCormick, who chaired the IOM's Immunization Safety Review Committee, told her fellow researchers when they first met in January 2001. "We are not ever going to come down that [autism] is a true side effect" of thimerosal exposure. According to transcripts of the meeting, the committee's chief staffer, Kathleen Stratton, predicted that the IOM would conclude that the evidence was "inadequate to accept or reject a causal relation" between thimerosal and autism. That, she added, was the result "Walt wants" -- a reference to Dr. Walter Orenstein, director of the National Immunization Program for the CDC.

For those who had devoted their lives to promoting vaccination, the revelations about thimerosal threatened to undermine everything they had worked for. "We've got a dragon by the tail here," said Dr. Michael Kaback, another committee member. "The more negative that [our] presentation is, the less likely people are to use vaccination, immunization -- and we know what the results of that will be. We are kind of caught in a trap. How we work our way out of the trap, I think is the charge."

Even in public, federal officials made it clear that their primary goal in studying thimerosal was to dispel doubts about vaccines. "Four current studies are taking place to rule out the proposed link between autism and thimerosal," Dr. Gordon Douglas, then-director of strategic planning for vaccine research at the National Institutes of Health, assured a Princeton University gathering in May 2001. "In order to undo the harmful effects of research claiming to link the [measles] vaccine to an elevated risk of autism, we need to conduct and publicize additional studies to assure parents of safety." Douglas formerly served as president of vaccinations for Merck, where he ignored warnings about thimerosal's risks.

In May of last year, the Institute of Medicine issued its final report. Its conclusion: There is no proven link between autism and thimerosal in vaccines. Rather than reviewing the large body of literature describing the toxicity of thimerosal, the report relied on four disastrously flawed epidemiological studies examining European countries, where children received much smaller doses of thimerosal than American kids. It also cited a new version of the Verstraeten study, published in the journal Pediatrics, that had been reworked to reduce the link between thimerosal and autism. The new study included children too young to have been diagnosed with autism and overlooked others who showed signs of the disease. The IOM declared the case closed and -- in a startling position for a scientific body -- recommended that no further research be conducted.

The report may have satisfied the CDC, but it convinced no one. Rep. David Weldon, a Republican physician from Florida who serves on the House Government Reform Committee, attacked the Institute of Medicine, saying it relied on a handful of studies that were "fatally flawed" by "poor design" and failed to represent "all the available scientific and medical research." CDC officials are not interested in an honest search for the truth, Weldon told me, because "an association between vaccines and autism would force them to admit that their policies irreparably damaged thousands of children. Who would want to make that conclusion about themselves?"

Under pressure from Congress and parents, the Institute of Medicine convened another panel to address continuing concerns about the Vaccine Safety Datalink Data Sharing program. In February, the new panel, composed of different scientists, criticized the way the VSD had been used in the Verstraeten study, and urged the CDC to make its vaccine database available to the public.

So far, though, only two scientists have managed to gain access. Dr. Mark Geier, president of the Genetics Center of America, and his son, David, spent a year battling to obtain the medical records from the CDC. Since August 2002, when members of Congress pressured the agency to turn over the data, the Geiers have completed six studies that demonstrate a powerful correlation between thimerosal and neurological damage in children. One study, which compares the cumulative dose of mercury received by children born between 1981 and 1985 with those born between 1990 and 1996, found a "very significant relationship" between autism and vaccines. Another study of educational performance found that kids who received higher doses of thimerosal in vaccines were nearly three times as likely to be diagnosed with autism and more than three times as likely to suffer from speech disorders and mental retardation. Another soon-to-be published study shows that autism rates are in decline following the recent elimination of thimerosal from most vaccines.
As the federal government worked to prevent scientists from studying vaccines, others have stepped in to study the link to autism. In April, reporter Dan Olmsted of UPI undertook one of the more interesting studies himself. Searching for children who had not been exposed to mercury in vaccines -- the kind of population that scientists typically use as a "control" in experiments -- Olmsted scoured the Amish of Lancaster County, Pennsylvania, who refuse to immunize their infants. Given the national rate of autism, Olmsted calculated that there should be 130 autistics among the Amish. He found only four. One had been exposed to high levels of mercury from a power plant. The other three -- including one child adopted from outside the Amish community -- had received their vaccines.

At the state level, many officials have also conducted in-depth reviews of thimerosal. While the Institute of Medicine was busy whitewashing the risks, the Iowa legislature was carefully combing through all of the available scientific and biological data. "After three years of review, I became convinced there was sufficient credible research to show a link between mercury and the increased incidences in autism," says state Sen. Ken Veenstra, a Republican who oversaw the investigation. "The fact that Iowa's 700 percent increase in autism began in the 1990s, right after more and more vaccines were added to the children's vaccine schedules, is solid evidence alone." Last year, Iowa became the first state to ban mercury in vaccines, followed by California. Similar bans are now under consideration in thirty-two other states.

But instead of following suit, the FDA continues to allow manufacturers to include thimerosal in scores of over-the-counter medications as well as steroids and injected collagen. Even more alarming, the government continues to ship vaccines preserved with thimerosal to developing countries -- some of which are now experiencing a sudden explosion in autism rates. In China, where the disease was virtually unknown prior to the introduction of thimerosal by U.S. drug manufacturers in 1999, news reports indicate that there are now more than 1.8 million autistics. Although reliable numbers are hard to come by, autistic disorders also appear to be soaring in India, Argentina, Nicaragua and other developing countries that are now using thimerosal-laced vaccines. The World Health Organization continues to insist thimerosal is safe, but it promises to keep the possibility that it is linked to neurological disorders "under review."

I devoted time to study this issue because I believe that this is a moral crisis that must be addressed. If, as the evidence suggests, our public-health authorities knowingly allowed the pharmaceutical industry to poison an entire generation of American children, their actions arguably constitute one of the biggest scandals in the annals of American medicine. "The CDC is guilty of incompetence and gross negligence," says Mark Blaxill, vice president of Safe Minds, a nonprofit organization concerned about the role of mercury in medicines. "The damage caused by vaccine exposure is massive. It's bigger than asbestos, bigger than tobacco, bigger than anything you've ever seen."

It's hard to calculate the damage to our country -- and to the international efforts to eradicate epidemic diseases -- if Third World nations come to believe that America's most heralded foreign-aid initiative is poisoning their children. It's not difficult to predict how this scenario will be interpreted by America's enemies abroad. The scientists and researchers -- many of them sincere, even idealistic -- who are participating in efforts to hide the science on thimerosal claim that they are trying to advance the lofty goal of protecting children in developing nations from disease pandemics. They are badly misguided. Their failure to come clean on thimerosal will come back horribly to haunt our country and the world's poorest populations.

NOTE: This story has been updated to correct several inaccuracies in the original, published version. As originally reported, American preschoolers received only three vaccinations before 1989, but the article failed to note that they were innoculated a total of eleven times with those vaccines, including boosters. The article also misstated the level of ethylmercury received by infants injected with all their shots by the age of six months. It was 187 micrograms - an amount forty percent, not 187 times, greater than the EPA's limit for daily exposure to methylmercury. Finally, because of an editing error, the article misstated the contents of the rotavirus vaccine approved by the CDC. It did not contain thimerosal. Salon and Rolling Stone regret the errors.

An earlier version of this story stated that the Institute of Medicine convened a second panel to review the work of the Immunization Safety Review Committee that had found no evidence of a link between thimerosal and autism. In fact, the IOM convened the second panel to address continuing concerns about the Vaccine Safety Datalink Data Sharing program, including those raised by critics of the IOM's earlier work. But the panel was not charged with reviewing the committee's findings. The story also inadvertently omitted a word and transposed two sentences in a quote by Dr. John Clements, and incorrectly stated that Dr. Sam Katz held a patent with Merck on the measles vaccine. In fact, Dr. Katz was part of a team that developed the vaccine and brought it to licensure, but he never held the patent. Salon and Rolling Stone regret the errors.

CLARIFICATION: After publication of this story, Salon and Rolling Stone corrected an error that misstated the level of ethylmercury received by infants injected with all their shots by the age of six months. It was 187 micrograms ? an amount forty percent, not 187 times, greater than the EPA's limit for daily exposure to methylmercury. At the time of the correction, we were aware that the comparison itself was flawed, but as journalists we considered it more appropriate to state the correct figure rather than replace it with another number entirely.

Since that earlier correction, however, it has become clear from responses to the article that the forty-percent number, while accurate, is misleading. It measures the total mercury load an infant received from vaccines during the first six months, calculates the daily average received based on average body weight, and then compares that number to the EPA daily limit. But infants did not receive the vaccines as a ?daily average? ? they received massive doses on a single day, through multiple shots. As the story states, these single-day doses exceeded the EPA limit by as much as 99 times. Based on the misunderstanding, and to avoid further confusion, we have amended the story to eliminate the forty-percent figure.

"Deadly Immunity," our story about the link between mercury in vaccines and the dramatic rise in autism among children [RS 977/978], sparked intense reaction from the medical establishment and several leading news organizations. The story, by Robert F. Kennedy Jr. -- part of an ongoing collaboration with Salon.com -- documented the government's efforts to conceal alarming data about the dangers of vaccines.
What is most striking is the lengths to which major media outlets have gone to disparage the story and to calm public fears -- even in the face of the questionable science on the subject. In a segment on World News Tonight titled "A Closer Look," ABC pointed out that Kennedy is "not a scientist or a doctor" and dismissed his extensive evidence as nothing more than "a few scientific studies." The network also trotted out its medical editor, Dr. Timothy Johnson, to praise the "impeccably impartial Institute of Medicine" and to again state that Kennedy is not a scientist.

The New York Times, in a front-page story on the subject, devoted only one line to Kennedy's article, which it said accused public-health officials and drugmakers of "conspiring" to hide the data on autism -- a word that our story neither used nor implied. (The Wall Street Journal, in an op-ed attacking the article, was even more misleading, using the word "conspiracy" four times.) The Times then went on, for more than a full page, to portray concerns over vaccines as nothing more than the misguided fears of parents who suffer from "scientific illiteracy," unable to understand the medical studies that prove immunizations to be safe. It depicted studies reviewed by the Institute of Medicine as definitive without even bothering to address the host of serious questions raised about their validity: conflicting diagnoses of autism, mixed-up data from HMOs and research skewed to exclude many sick kids.

Rolling Stone and Salon fact-checked the article thoroughly before publication, insisting on primary documentation for every statement in the story, and posted links to the most significant materials online to enable readers to judge for themselves. The final article contained six errors. These ranged from inadvertently transposing a quote and confusing a drug license for a patent to relying on a figure that incorrectly calculated an infant's exposure to mercury over six months, rather than citing the even more dangerous amount injected on a single day. (The mistakes were corrected online as soon as they were discovered and can be viewed in detail at both RollingStone.com and Salon.com.)

It is important to note, however, that none of the mistakes weaken the primary point of the story. The government's own records show that it has failed to do the science necessary to put to rest reasonable concerns about vaccines. If the scientists had simply done their job rather than covering their tracks, there would be no controversy today. Instead, the government cannot even provide a definitive figure of the number of cases of autism among American children -- a number obviously critical to any serious scientific investigation -- and yet expects the public to believe that it has ruled out any link between vaccines and an illness it does not even track.

"Science," as one doctor in our story insisted, "is best left to scientists." But when the scientists fail to do their job, resorting to closed-door meetings and rigged studies, others in society have not only a right but a moral obligation to question their work. In the coming years, further research may indeed demonstrate that mercury in vaccines is not responsible for the rise in autism. For now, though, we can only raise a very real and legitimate alarm -- and hope that the government's well-documented mishandling of its own research did not needlessly jeopardize the health of hundreds of thousands of children.
(Posted Jul 14, 2005)

After years of insisting there is no evidence to link vaccines with the onset of autism spectrum disorder (ASD), the US government has quietly conceded a vaccine-autism case in the Court of Federal Claims.

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Buzz up!on Yahoo!The unprecedented concession was filed on November 9, and sealed to protect the plaintiff's identify. It was obtained through individuals unrelated to the case.

The claim, one of 4,900 autism cases currently pending in Federal "Vaccine Court," was conceded by US Assistant Attorney General Peter Keisler and other Justice Department officials, on behalf of the Department of Health and Human Services, the "defendant" in all Vaccine Court cases.

The child's claim against the government -- that mercury-containing vaccines were the cause of her autism -- was supposed to be one of three "test cases" for the thimerosal-autism theory currently under consideration by a three-member panel of Special Masters, the presiding justices in Federal Claims Court.

Keisler wrote that medical personnel at the HHS Division of Vaccine Injury Compensation (DVIC) had reviewed the case and "concluded that compensation is appropriate."

The doctors conceded that the child was healthy and developing normally until her 18-month well-baby visit, when she received vaccinations against nine different diseases all at once (two contained thimerosal).

Days later, the girl began spiraling downward into a cascade of illnesses and setbacks that, within months, presented as symptoms of autism, including: No response to verbal direction; loss of language skills; no eye contact; loss of "relatedness;" insomnia; incessant screaming; arching; and "watching the florescent lights repeatedly during examination."

Seven months after vaccination, the patient was diagnosed by Dr. Andrew Zimmerman, a leading neurologist at the Kennedy Krieger Children's Hospital Neurology Clinic, with "regressive encephalopathy (brain disease) with features consistent with autistic spectrum disorder, following normal development." The girl also met the Diagnostic and Statistical Manual for Mental Disorders (DSM-IV) official criteria for autism.

In its written concession, the government said the child had a pre-existing mitochondrial disorder that was "aggravated" by her shots, and which ultimately resulted in an ASD diagnosis.

"The vaccinations received on July 19, 2000, significantly aggravated an underlying mitochondrial disorder," the concession says, "which predisposed her to deficits in cellular energy metabolism, and manifested as a regressive encephalopathy with features of ASD."

This statement is good news for the girl and her family, who will now be compensated for the lifetime of care she will require. But its implications for the larger vaccine-autism debate, and for public health policy in general, are not as certain.

In fact, the government's concession seems to raise more questions than it answers.

1) Is there a connection between vaccines, mitochondrial disorders and a diagnosis of autism, at least in some cases?

Mitochondria, you may recall from biology class, are the little powerhouses within cells that convert food into electrical energy, partly through a complex process called "oxidative phosphorylation." If this process is impaired, mitochondrial disorder will ensue.

The child in this case had several markers for Mt disease, which was confirmed by muscle biopsy. Mt disease is often marked by lethargy, poor muscle tone, poor food digestion and bowel problems, something found in many children diagnosed with autism.

But mitochondrial disorders are rare in the general population, affecting some 2-per-10,000 people (or just 0.2%). So with 4,900 cases filed in Vaccine Court, this case should be the one and only, extremely rare instance of Mt disease in all the autism proceedings.

Mitochondrial disorders are now thought to be the most common disease associated with ASD. Some journal articles and other analyses have estimated that 10% to 20% of all autism cases may involve mitochondrial disorders, which would make them one thousand times more common among people with ASD than the general population.

Another article, published in the Journal of Child Neurology and co-authored by Dr. Zimmerman, showed that 38% of Kennedy Krieger Institute autism patients studied had one marker for impaired oxidative phosphorylation, and 47% had a second marker.

The authors -- who reported on a case-study of the same autism claim conceded in Vaccine Court -- noted that "children who have (mitochondrial-related) dysfunctional cellular energy metabolism might be more prone to undergo autistic regression between 18 and 30 months of age if they also have infections or immunizations at the same time."

An interesting aspect of Mt disease in autism is that, with ASD, the mitochondrial disease seems to be milder than in "classic" cases of Mt disorder. In fact, classic Mt disease is almost always inherited, either passed down by the mother through mitochondrial DNA, or by both parents through nuclear DNA.

In autism-related Mt disease, however, the disorder is not typically found in other family members, and instead appears to be largely of the sporadic variety, which may now account for 75% of all mitochondrial disorders.

Meanwhile, an informal survey of seven families of children with cases currently pending in Vaccine Court revealed that all seven showed markers for mitochondrial dysfunction, dating back to their earliest medical tests. The facts in all seven claims mirror the case just conceded by the government: Normal development followed by vaccination, immediate illness, and rapid decline culminating in an autism diagnosis.

2) With 4,900 cases pending, and more coming, will the government concede those with underlying Mt disease -- and if it not, will the Court award compensation?

The Court will soon begin processing the 4900 cases pending before it. What if 10% to 20% of them can demonstrate the same Mt disease and same set of facts as those in the conceded case? Would the government be obliged to concede 500, or even 1,000 cases? What impact would that have on public opinion? And is there enough money currently in the vaccine injury fund to cover so many settlements?

When asked for a comment last week about the court settlement, a spokesman for HHS furnished the following written statement:

"DVIC has reviewed the scientific information concerning the allegation that vaccines cause autism and has found no credible evidence to support the claim. Accordingly, in every case under the Vaccine Act, DVIC has maintained the position that vaccines do not cause autism, and has never concluded in any case that autism was caused by vaccination."

3) If the government is claiming that vaccines did not "cause" autism, but instead aggravated a condition to "manifest" as autism, isn't that a very fine distinction?

For most affected families, such linguistic gymnastics is not so important. And even if a vaccine injury "manifested" as autism in only one case, isn't that still a significant development worthy of informing the public?

On the other hand, perhaps what the government is claiming is that vaccination resulted in the symptoms of autism, but not in an actual, factually correct diagnosis of autism itself.

4) If the government is claiming that this child does NOT have autism, then how many other children might also have something else that merely "mimics" autism?

Is it possible that 10%-20% of the cases that we now label as "autism," are not autism at all, but rather some previously undefined "look-alike" syndrome that merely presents as "features" of autism?

This question gets to the heart of what autism actually is. The disorder is defined solely as a collection of features, nothing more. If you have the features (and the diagnosis), you have the disorder. The underlying biology is the great unknown.

But let's say the government does determine that these kids don't have actual "autism" (something I speculated on HuffPost a year ago). Then shouldn't the Feds go back and test all people with ASD for impaired oxidative phosphorylation, perhaps reclassifying many of them?

If so, will we then see "autism" cases drop by tens, if not hundreds of thousands of people? Will there be a corresponding ascension of a newly described disorder, perhaps something like "Vaccine Aggravated Mitochondrial Disease with Features of ASD?"

And if this child was technically "misdiagnosed" with DSM-IV autism by Dr Zimmerman, how does he feel about HHS doctors issuing a second opinion re-diagnosis of his patient, whom they presumably had neither met nor examined? (Zimmerman declined an interview).

And along those lines, aren't Bush administration officials somewhat wary of making long-distance, retroactive diagnoses from Washington, given that the Terry Schiavo incident has not yet faded from national memory?

5) Was this child's Mt disease caused by a genetic mutation, as the government implies, and wouldn't that have manifested as "ASD features" anyway?

In the concession, the government notes that the patient had a "single nucleotide change" in the mitochondrial DNA gene T2387C, implying that this was the underlying cause of her manifested "features" of autism.

While it's true that some inherited forms of Mt disease can manifest as developmental delays, (and even ASD in the form of Rhett Syndrome) these forms are linked to identified genetic mutations, of which T2387C is not involved. In fact little, if anything, is known about the function of this particular gene.

What's more, there is no evidence that this girl, prior to vaccination, suffered from any kind of "disorder" at all- genetic, mitochondrial or otherwise. Some forms of Mt disease are so mild that the person is unaware of being affected. This perfectly developing girl may have had Mt disorder at the time of vaccination, but nobody detected, or even suspected it.

And, there is no evidence to suggest that this girl would have regressed into symptoms consistent with a DSM-IV autism diagnosis without her vaccinations. If there was such evidence, then why on earth would these extremely well-funded government attorneys compensate this alleged injury in Vaccine Court? Why wouldn't they move to dismiss, or at least fight the case at trial?

The concession raises at least two critical research questions: What are the causes of Mt dysfunction; and how could vaccines aggravate that dysfunction to the point of "autistic features?"

While some Mt disorders are clearly inherited, the "sporadic" form is thought to account for 75% of all cases, according to the United Mitochondrial Disease Foundation. So what causes sporadic Mt disease? "Medicines or other toxins," says the Cleveland Clinic, a leading authority on the subject.

Use of the AIDS drug AZT, for example, can cause Mt disorders by deleting large segments of mitochondrial DNA. If that is the case, might other exposures to drugs or toxins (i.e., thimerosal, mercury in fish, air pollution, pesticides, live viruses) also cause sporadic Mt disease in certain subsets of children, through similar genotoxic mechanisms?

Among the prime cellular targets of mercury are mitochondria, and thimerosal-induced cell death has been associated with the depolarization of mitochondrial membrane, according to the International Journal of Molecular Medicine among several others. (Coincidently, the first case of Mt disease was diagnosed in 1959, just 15 years after the first autism case was named, and two decades after thimerosal's introduction as a vaccine preservative.)

Regardless of its cause, shouldn't HHS sponsor research into Mt disease and the biological mechanisms by which vaccines could aggravate the disorder? We still do not know what it was, exactly, about this girl's vaccines that aggravated her condition. Was it the thimerosal? The three live viruses? The two attenuated viruses? Other ingredients like aluminum? A combination of the above?

And of course, if vaccine injuries can aggravate Mt disease to the point of manifesting as autism features, then what other underlying disorders or conditions (genetic, autoimmune, allergic, etc.) might also be aggravated to the same extent?

Should the government develop and approve new treatments for "aggravated mitochondrial disease with ASD features?" Interestingly, many of the treatments currently deployed in Mt disease (i.e., coenzyme Q10, vitamin B-12, lipoic acid, biotin, dietary changes, etc.) are part of the alternative treatment regimen that many parents use on their children with ASD.

And, if a significant minority of autism cases can be linked to Mt disease and vaccines, shouldn't these products one day carry an FDA Black Box warning label, and shouldn't children with Mt disorders be exempt from mandatory immunization?

It's too early to tell. But this concession could conceivably make it more difficult for some officials to continue insisting there is "absolutely no link" between vaccines and autism.

It also puts the Federal Government's Vaccine Court defense strategy somewhat into jeopardy. DOJ lawyers and witnesses have argued that autism is genetic, with no evidence to support an environmental component. And, they insist, it's simply impossible to construct a chain of events linking immunizations to the disorder.

Government officials may need to rethink their legal strategy, as well as their public relations campaigns, given their own slightly contradictory concession in this case.

The public, (including world leaders) will demand to know what is going on inside the US Federal health establishment. Yes, as of now, n=1, a solitary vaccine-autism concession. But what if n=10% or 20%? Who will pay to clean up that mess?

The significance of this concession will unfortunately be fought over in the usual, vitriolic way -- and I fully expect to be slammed for even raising these questions. Despite that, the language of this concession cannot be changed, or swept away.

Its key words are "aggravated" and "manifested." Without the aggravation of the vaccines, it is uncertain that the manifestation would have occurred at all.

When a kid with peanut allergy eats a peanut and dies, we don't say "his underlying metabolic condition was significantly aggravated to the extent of manifesting as an anaphylactic shock with features of death."

No, we say the peanut killed the poor boy. Remove the peanut from the equation, and he would still be with us today.

Many people look forward to hearing more from HHS officials about why they are settling this claim. But whatever their explanation, they cannot change the fundamental facts of this extraordinary case:

The United State government is compensating at least one child for vaccine injuries that resulted in a diagnosis of autism.

David Kirby is the author of "Evidence of Harm - Mercury in Vaccines and the Autism Epidemic, A Medical Controversy" (St. Martins Press 2005.

MidwestDad (See profile | I'm a fan of MidwestDad)
The petitioners agreed to withdraw the test case after the respondents conceded that vaccines aggravated Hannah's pre-existing condition. It has nothing to do with thimerosal, or MMR, or a combination of the two.
Here is a link to the full text:
http://tinyurl.com/2wlpvo

Good point Chapnalli, why did the petitioners' attorneys agree to removing this case? If you want to prove that vaccines cause autism, then why agree to strike a test case with a strong vaccine-autism link?
I think the likely explanation is that the test case does not come close to proving the link. Which means Mr. Kirby's claim is suspect. He needs to release the document he supposedly has, otherwise his claim will remain suspect. How would that help our kids if Kirby's keeps everyone guessing and speculating? There's an easy way to end this right now.