First of all, I don't know which side in this debate is correct. I have argued both sides in the past--sometimes just to be devil's advocate. But even with the recent discrediting of the
de facto "leading investigator" for the "vaccines cause autism" side, there still are many studies out there that link vaccines and autism.
I will say, though, that those who are "pro-vaccine" seem very condescending in their assumptions that anyone who questions the safety of vaccines is someone who wants to go back to a time before "indoor plumbing" or prefers the "dark ages." Or that someone who questions vaccine safety thinks vaccines are evil. Those I've heard or read who question vaccine safety typically do not denounce vaccines as a whole. They question the compounds used as "adjuvants" which are put in vaccines to overstimulate the immune system to react more quickly to the vaccine so less vaccine can be used--a cost cutting method, mostly. These adjuvants have included themerosol (which contains mercury), animal and insect DNA, a compound called "squalene" in Anthrax vaccines given to soldiers in the first Gulf War that is suspected to cause Gulf War Syndrome, dead viruses and other sinister sounding compounds.
So again, I would like to know exactly where I stand on this issue, but I don't. Here are some articles that I find compelling as far as the debate goes:
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The Poisoning of a Generation
By STEVEN HIGGS
This is the time of year when classroom responsibilities overwhelm my journalistic passions, and my writing tends to be more reflection than exposition. And let me tell you, nothing spurs reflexive contemplation like finding yourself in polar opposition to someone whose life work has profoundly influenced your own.
In my case, that someone is Dr. Philip J. Landrigan from the Mount Sinai School of Medicine, whose research at the Children's Environmental Health Center there first caught my attention in the late 1990s when I was a senior environmental writer at the Indiana Department of Environmental Management (IDEM). When I began exploring the links between toxic pollution and autism 17 months ago, a 2006 study Landrigan co-wrote titled "Developmental neurotoxicity of industrial chemicals" was the first link that Google produced when I searched for "autism and environment."
Nearly a year and a half later, I am persuaded that mercury and/or other chemicals in vaccines are among the industrial chemicals that caused the autism epidemic of the past two decades. I do not believe that vaccines caused the epidemic, but my work has convinced me that neurotoxins in them contributed to it. And in some children, they did cause autism. The question for them isn't whether, it's how, and it demands an answer.
After having followed Phil Landrigan's work in this field for more than a decade, it's inconceivable to me that anyone familiar with it would deny that proposition.
So, when I read, "There is no credible evidence that vaccines cause autism." in the abstract of Landrigan's new paper "What causes autism? Exploring the environmental contribution," I was inspired to reflection.
I initially felt he was parsing words for the publisher, the journal Current Opinion in Pediatrics. Given the politics and history of vaccines in America, it's reasonable to assume that any pediatric researcher who deviates from the American Academy of Pediatrics (AAP) mantra -- The case against vaccines is closed, never to be opened again. -- could suffer serious consequences.
Regardless, as more than one source I have interviewed or read since October 2008 has observed, science is only as good as the hypotheses it pursues. The American experience with mercury-containing vaccines and autism is unique. And, as the studies Landrigan cites in his paper show, those used to "debunk" the notion that vaccines may have contributed to autism have not explored the right hypotheses.
***
The American experience with mercury-containing vaccines parallels the autism epidemic to the letter.
In 1930, the pharmaceutical manufacturer Eli Lilly & Co. patented a mercury-based preservative called thimerosal for use in childhood vaccines. According to a 2003 congressional report, despite repeated requests through the years, Lilly never tested thimerosal for its human health impacts. For 70 years, Lilly relied on a "woefully inadequate" and "uncontrolled study" from the 1920s as proof thimerosal was safe, the report said.
In 1943, autism was first identified by Austrian psychiatrist Leo Kanner, whose study "Autistic Disturbances of Affective Contact" said he had noticed such children since 1938.
Starting in the 1940s, American children were vaccinated for diptheria, tetanus and pertussis (DTP). A polio shot was added in 1955, and measles, mumps, rubella (MMR) joined the list in 1971.
In 1989, a fully vaccinated child of 5 had received a total of 11 injections of these three vaccines. In 1990 and 1991, two more were added to the schedule with seven more shots, including hepatitis B at birth. And in 1995 and 1998, an additional two vaccines with five more shots were added, bringing the total number of injections to 23.
Four more vaccines were added in 2000, 2004 and 2006. The CDC and AAP's recommended vaccination schedule today says American children should receive 36 shots before they enter first grade, the most aggressive vaccination schedule in the world.
Canada is a distant second with 28, according to a 2009 study published by Generation Rescue titled "Autism and vaccines around the world." The average number of vaccinations among 30 industrialized countries is 18.
Meanwhile, between 1980 and 1994, the incidence of California children with autism jumped 373 percent, from 1 in every 2,272 live births to 1 in 480, according to a 2001 study published in the Journal of the American Medical Association.
Three Centers for Disease Control (CDC) studies of children born in 1992, 1994 and 1996 -- after physicians began immunizing children at birth with vaccines containing mercury and aluminum -- showed continued, alarming increases at multiple sites nationwide. The first two, published in 2007, showed the autism rate had jumped to 1 in 150. The second, published in December 2009, put the figure at 1 in 110.
A CDC survey of parents released in October 2009 said 1 in 90 has a child on the autism spectrum.
***
In a move that some have called an example of the "precautionary principle," the AAP and U.S. Public Health Service issued a joint statement in 1999 that said "thimerosal-containing vaccines should be removed as soon as possible." The precautionary principle actually says chemicals should be considered guilty until proven innocent, not innocent until proven guilty, as happened here.
A letter from a U.S. Food and Drug Administration associate commissioner to U.S. Rep. Dave Weldon, R-Fla., dated June 18, 2003, said drug companies had reported that the last of the thimerosal vaccines in circulation had expiration dates in 2002. Anecdotal evidence from parents, however, suggests that children still received thimerosal-containing vaccines in 2003.
Some vaccines in use today, annual flu shots and the H1N1, for example, still contain mercury.
***
Not every vaccine used during the thimerosal era contained mercury. But most did, along with aluminum, another potent neurotoxin. And millions of American children were exposed to ominously large doses of both of these industrial chemicals.
The post-1991 AAP schedule called for children to receive one vaccine at birth, five at two months, five more at four months and an additional four at six months.
And that, according to the 2003 congressional report, authored by Indiana Congressman Dan Burton, R-Indianapolis, was tantamount to poisoning a generation of children. "In July 2000, it was estimated that 8,000 children a day were being exposed to mercury in excess of federal guidelines through their mandatory vaccines," the report said.
In some cases, when parents would miss one of their "well-baby visits," doctors would double up the shots. Some American children received 125 times the amount of mercury that the U.S. Environmental Protection Agency (EPA) says is safe in a single visit.
And in tens of thousands of cases, like Generation Rescue co-founder J.B. Handley's son Jamie in Portland, Ore., their parents carried them into their pediatricians' offices normal and healthy and watched them "systematically decline" over the course of their "well-baby" visits where they "received multiple shots," Handley said in an e-mail.
And Handley has spoken to hundreds of parents who shared the experience of Congressman Burton, who watched his grandson immediately and permanently regress into autism. In a speech on the House floor in 2002, Burton described the experience: "He actually got nine shots in one day, seven of which had mercury.
Two days later he was banging his head against the wall, flapping his arms, had chronic diarrhea and constipation at the same time, and we lost him. He wouldn't talk to us. He became incommunicado."
***
Before addressing specifics in Landrigan's section on "Vaccines and autism," I should note that I have corresponded with him over the past 18 months and quoted him often in my stories, columns and blogs on children's environmental health. Just last week I featured the rest of his autism study in a piece called "Landrigan calls for more research into autism-environment link." In my experience, he has been a man of few words who preferred to let his published work speak for him.
So I wasn't surprised that, after I e-mailed him about the no-credible-evidence line in his autism paper, he sent me the full study and referred me to the vaccines portion. When I questioned the relevance of the studies he cites to my proposition that mercury-containing vaccines caused some of the autism epidemic in the United States, he responded that no study is definitive, but a 2005 Japanese one was close.
"In Yokohama, Japan, the MMR vaccination rate declined significantly between 1988 and 1992, and no MMR vaccine was administered in 1993 or thereafter," Landrigan wrote in his autism study. "Despite declining immunizations, cumulative incidence of ASD (autism spectrum disorder) increased significantly each year from 1988 through 1996 and rose especially dramatically beginning in 1993. Overall incidence of autism nearly doubled in those years."
Autism spectrum disorders include Autism Disorder, sometimes called full-blown autism; Asperger's Disorder, sometimes called high-functioning autism; and Pervasive Developmental Disorder-Not Otherwise Specified.
The counterarguments to the Yokohama study reject its application to the American experience.
First, it's a study of but one vaccine out of the 11 that American children received over the decade and a half when thimerosal was heavily used. And, as the study itself says, under Japanese law children received only three vaccinations during the study period -- measles, rubella and MMR -- and in nowhere near the same doses as in the United States. Japanese children today receive 11 shots over the course of their childhoods. American kids receive 36. And the MMR has never contained thimerosal.
The Yokohama study's "Conclusion" states: "The significance of this finding is that MMR vaccination is most unlikely to be a main cause of ASD, that it cannot explain the rise over time in the incidence of ASD."
No credible source I've encountered has argued that the MMR, thimerosal or any other single vaccine or ingredient in vaccines are solely responsible for the autism epidemic. To argue that would be as foolhardy as denying the possibility that mercury in vaccines may have caused or helped cause some kids' regression into autism, or that this particular hypothesis isn't worth pursuing.
***
Landrigan cites seven studies from the United States, United Kingdom and Japan as support for his no-credible-evidence assertion. One, a Danish study published in the New England Journal of Medicine in 2002, is often cited as the last word on the matter.
The Danish study compared autism rates in immunized and unimmunized children between 1991 and 1998, Landrigan wrote in his study. It found "no association between age at immunization or season at immunization and rate of autism."
Handley, however, said in an e-mail that the study used the term unimmunized to mean children who did not receive the MMR. All of the children had been inoculated against other diseases. And, he and others point out, the Danes removed thimerosal from their vaccines in 1992.
Citing the Danish study is, as many in the autism community have argued, comparing apples to pears.
***
One California study published in the New England Journal of Medicine in 2007 that did look at American children from the thimerosal era analyzed "neuropsychological function" in 1,047 children, Landrigan wrote, but it "found no consistent correlation between neuropsychological functioning at age 7-10 years and early exposure to thimerosal-containing vaccines."
The study, however, intentionally did not include autism. "Since the CDC is conducting a separate case-control study of autism in relation to mercury exposure, a measure of autism was not included in the test battery," it explained.
And while the study did reach the conclusions Landrigan outlines, some of them provide fodder for contemplation.
The study, titled "Early Thimerosal Exposure and Neuropsychological Outcomes at 7 to 10 Years," found that exposure to mercury between birth and 28 days was related to significantly poorer "speech articulation." It also found a "significant negative association with verbal IQ" among girls.
"Although the effect sizes were very small, the speech-articulation findings among all children and the lower verbal IQ findings among girls suggest a possible adverse association between neonatal exposure to mercury and language development," the study concludes.
Communication deficits are signature symptoms of autism. Children on the "full-blown autism" end of the spectrum frequently stop talking altogether.
While the study "found no association between neonatal exposure to mercury from thimerosal and total IQ," among boys it found "a significant positive association with performance IQ." Boys are four times more likely to develop autism than girls, and exceptional intelligence is common with Asperger's disorder.
***
I've spent most of the past 28 years journalistically investigating conflicts between environmental victims and experts in the relevant fields. And, I can say without qualification, the victims have been right and the experts wrong in every significant story I've covered. I can't think of a single exception.
And with respect to vaccines and autism, I say again, without reservation, parents like J.B. Handley and grandparents like Dan Burton are right about vaccines and autism. The experts are wrong, and their behaviors -- their vitriolic attacks upon those who disagree, their underhanded political tactics -- suggest they know they were wrong.
For noble reasons, the most common argument against unfettered scientific analysis of the thimerosal era is that talking about vaccines and autism will scare parents away from vaccination, which could lead to outbreaks of dangerous illnesses, perhaps of epidemic proportions.
The most obvious counterargument is that we are in the middle (probably the beginning) of epidemics of horrific proportions -- of autism, of attention-deficit hyperactivity disorder, of cognitive disabilities, of learning delays. One in six American children in public schools today receive special education for those and other conditions. I've identified school districts in Southern Indiana where it is more than one in four.
Americans need to know what caused these epidemics. And open, honest, rigorous debate and study is the only path to that end.
***
Where to start that process also seems obvious. Every area of environmental contamination I've ever explored, from PCBs in the early 1980s to thimerosal today, began with studies of populations that were subjected to extreme exposures.
The earliest PCB studies involved Japanese and Taiwanese who accidentally ate food cooked in PCB-contaminated rice oil in 1968 and 1979, respectively. Early studies of mercury poisoning analyzed victims contaminated by industrial discharges into Japanese waterways in the 1950s and bread cooked with mercury-contaminated grain in Iraq in 1971 and '72.
Well, we have a generation of American children today, who range in age from roughly 7 to 19, who were acutely exposed to high levels of two known neurotoxins through their vaccinations, and whose medical histories are comprehensively documented.
How difficult or costly could it be to identify a statistically significant population of children who received 125 times the recommended EPA level of mercury exposure and study their health histories? Or of kids who received 50 times the recommended exposure? Or 25 times?
Many parents refused to have their children vaccinated for hepatitis B at birth. How hard would it be to compare their children to those who were vaccinated? There are millions of both.
***
Most of the reasons why the politically powerful, pro-vaccine forces virulently oppose research of any kind into America's thimerosal experience are obvious and predictable, such as money and liability.
The political and legal history of the autism-and-vaccine debate is replete with dire warnings that parents recovering jury awards for damages caused by vaccines would wreak economic havoc on the industry and impede its ability to protect public health.
Corporations, after all, manufactured and sold the toxins, and doctors injected them into the children's developing bodies. In trial lawyer parlance, both have deep pockets.
Indeed, laws passed by Congress starting in the mid-1980s have made it virtually impossible for parents to be compensated for vaccine-induced injuries to their children.
Why public health officials abdicated their responsibilities to protect citizens from environmental toxins like mercury and aluminum is likewise clear. The agencies were run by Bush-Clinton-Bush appointees, whose jobs were to not do their jobs.
And their bosses came from the pharmaceutical industries. President George H.W. Bush was a Lilly board member before he was elected president. President George W. Bush's first budget director in 2000 was then-Lilly Vice President and now-Indiana Governor Mitch Daniels, who has opened the door to a 2012 bid for president.
***
Beyond their personal liability, the docs add a new twist to an old tale.
Every person I have told the mercury-in-vaccine facts to has been dumfounded. Unless they have a special-needs child in their families, educated, curious, engaged citizens have no clue that one in six American children has a developmental disability, or that they had dangerously high levels of known neurotoxins injected into their developing, infant bodies, by their doctors. They're appalled when they hear it.
But all the guys I knew who became doctors, and all the docs I've ever spoken to as a reporter or a patient, have been the smartest people in the room. Yet, I wrote about mercury's neurotoxic properties when I worked at IDEM in 1996. And their fellow doctors in other countries, like Denmark, stopped using mercury in vaccines a decade before they finally did.
Another question that demands an answer is: Why did the AAP perpetuate for so long what can arguably be called the poisoning of a generation? Isn't one of a doctor's sacred credos, "First, do no harm"?
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Deadly Immunity
June 16, 2005
Download RFK's original research paper:
Tobacco Science and the Thimerosal Scandal.pdf
In June 2000, a group of top government scientists and health officials gathered for a meeting at the isolated Simpsonwood conference center in Norcross, Ga. 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 52 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 11-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. Congress repealed the measure 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 preeminent 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 25 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 11 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 20-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 20 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 22 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, 10 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 24 hours of birth, and 2-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 6-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 11 vaccinations -- for polio, diphtheria-tetanus-pertussis and measles-mumps-rubella. A decade later, thanks to federal recommendations, children were receiving a total of 22 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. Infants who received all their vaccines, plus boosters, by the age of six months were being injected with a total of 187 micrograms of ethylmercury -- a level 40 percent 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. Under the expanded schedule of vaccinations, multiple shots were often administered on a single day: At two months, when the infant brain is still at a critical stage of development, children routinely received three innoculations that delivered 99 times the approved limit of mercury.
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 advisors, told me, "I think if we really have an influenza pandemic -- and certainly we will in the next 20 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 advisors 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 to study vaccine safety, 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, Penn., 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," state Sen. Ken Veenstra, a Republican who oversaw the investigation, told the magazine Byronchild earlier this year. "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 32 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.
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Now for the other side...
U.S. Court Finds No Link Between Vaccines, Autism
By Shankar Vedantam
Washington Post Staff Writer
Friday, February 13, 2009
A special federal court ruled yesterday that vaccines do not cause autism and that thousands of families with autistic children are not entitled to compensation, delivering a major blow to an international movement that has tried for years to link childhood immunizations with the devastating disorder.
The ruling closes one chapter in a long feud that has pitted families with autistic children against the bulk of the scientific establishment. Those who believe passionately that routine childhood shots are to blame for the rising toll of autism feel they are locked in a David-and-Goliath struggle against vaccine manufacturers, corrupt scientists, federal agencies and the mainstream media. It remains to be seen whether yesterday's ruling will end the controversy -- or be seen as just more evidence of what some call a conspiracy.
The vast majority of credible scientific studies have shown -- and all federal health agencies have strenuously argued -- that there is no connection between vaccines and autism. And public health officials have repeatedly warned that fewer immunizations will endanger children's lives.
Nevertheless, concerns about vaccines such as the "MMR" shot, which protects children against measles, mumps and rubella, have grown so widespread that some parents are choosing to forgo vaccinations. About one in 12 children does not receive the MMR vaccine in the United States, according to the National Center for Health Statistics.
Yesterday's ruling involved three separate cases, each of which explored a different mechanism by which vaccines might cause autism. Working independently, three special masters acting as judges in the federal "vaccine court" issued separate but similar rulings that found no evidence that the vaccines had caused the children's disorders.
The decisions are especially telling because the rules of the vaccine court did not require the plaintiffs to prove their cases with scientific certainty -- all the families needed to show was a preponderance of the evidence, or "50 percent and a hair." To the extent that these cases are representative of the claims made by some 4,800 other families seeking compensation, those cases would appear to be on shaky ground.
Ruling on a case brought by Theresa and Michael Cedillo of Yuma, Ariz., special master George L. Hastings used italicized words for emphasis and wrote that his extensive analysis of the evidence showed that the Cedillos' vaccine-autism theory was "very wrong."
"Unfortunately, the Cedillos have been misled by physicians who are guilty, in my view, of gross medical misjudgment," Hastings wrote.
The Cedillos contend that their daughter Michelle abruptly fell sick a week after she received an MMR shot when she was about 16 months old. Today, at age 14, she requires round-the-clock care, suffers from seizures, has lost nearly all her vision and has constant abdominal pain.
"We are terribly disappointed by the decision," Theresa Cedillo said in an interview. Referring to Michelle, she said, "I feel she was vaccine-injured and should be entitled to compensation."
The rulings are subject to appeal, and Kevin Conway, a lawyer representing the Cedillos, said there was no question of throwing in the towel.
In another test case, special master Denise K. Vowell heard charges brought by Kathryn and Joseph Snyder of Port Orange, Fla., who argued that the MMR vaccine, or a mercury-based preservative in it called thimerosal, had triggered in their son Colten pervasive developmental disorder -- part of the "autism spectrum."
"The evidence presented was both voluminous and extraordinarily complex," Vowell wrote in her ruling. But she added that there was little doubt about the right answer: The experts contending there is no link between autism and vaccines "were far more qualified, better supported by the weight of scientific research and authority, and simply more persuasive on nearly every point in contention."
In the third test case, special master Patricia Campbell-Smith heard a claim by Rolf and Angela Hazlehurst of Jackson, Tenn., parents of William Yates Hazlehurst. They charged that the MMR vaccine or a component of it had caused "regressive autism" in their son. Agreeing with the other special masters, Campbell-Smith said that she was "moved as a person and as a parent by the Hazlehursts' account," but that their evidence fell short.
The three cases involved some 5,000 pages of transcripts, 939 medical articles and 50 expert reports, and the three decisions ran to more than 650 pages altogether.
The ruling was welcomed in statements by the Department of Health and Human Services and the American Medical Association.
"This is a real victory for children and a great day for science," said Philadelphia pediatrician and vaccine expert Paul Offit, in a statement issued by the vaccine advocacy group Every Child by Two. "I hope that this decision will finally put parents' fears to rest and that we can once again concentrate on protecting children from the resurgence of deadly vaccine-preventable diseases such as measles and whooping cough."
The vaccine court was set up by Congress in 1986 as part of the National Vaccine Injury Compensation Program to compensate people who suffer the occasional side effects of vaccines. Rather than have victims sue vaccine-makers in civil court -- potentially putting them out of business and jeopardizing a major component of the country's public health infrastructure -- the court has a "no-fault" system that requires victims to prove to a special master only that vaccines harmed them, and not that anyone intentionally caused the harm.
It is unclear what effect the ruling will have on the determined grass-roots effort that insists there is a connection between vaccines and autism, a movement that has been embraced by several celebrities and politicians. In June 2005, Robert F. Kennedy Jr. wrote an article in Rolling Stone charging a "government cover-up of a mercury/autism scandal."
Two years later, Rep. Dan Burton (R-Ind.) told fellow members of Congress: "I believe, as do many credible scientists and researchers, that the clear correlation between the dramatic rise in the number of autism cases, and the rapid expansion of the childhood vaccination schedule during that 20-year period, points to the mercury-based preservative thimerosal -- routinely used in pediatric vaccines during the period -- as a contributing factor to our country's literal epidemic of autism. In fact, I firmly believe my own grandson became autistic after receiving nine shots."
James Moody, a lawyer advising the plaintiffs and director of SafeMinds, a research and advocacy think tank that endorses a vaccine-autism link, predicted that the autism cases would be appealed and eventually wind up in civil court, where plaintiffs could make their cases to a jury and get access to government documents.
"The government does not fund the science to show a connection between vaccines and autism, and the courts say there isn't enough evidence to show a connection," Moody said. "When the vaccine court says you haven't met the standard of evidence, that is a call for more science, not that this controversy is at an end."
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Vaccines do not cause autism!
by Phil Plait
I just can’t make this any clearer. Vaccines do not cause autism. Study after study has shown this, in multiple ways. The removal of the MMR (mumps-measles-rubella) vaccine in Japan did not lead to a decline in the number of cases of autisms diagnosed; instead the number of children falling in the autism spectrum increased.
A study in Denmark (link goes to Science Magazine; subscription required) showed the same thing: long after thimerosal-based vaccines were discontinued, autism-related diagnoses continued to rise:
Now the first big epidemiological studies weigh in. One comes from Denmark, which eliminated thimerosal from childhood vaccines in 1992. A team led by Kreesten Madsen of the Danish Epidemiology Science Centre in Aarhus reasoned that if thimerosal were a major cause of autism, incidence of new cases should drop once it was removed. In the September issue of the journal Pediatrics, they report that, instead of declining, the incidence continued to skyrocket after 1992.
They supply a graph:
This graph is a clincher. If they were related in any way, you'd see a decline. Instead it continues to rise. Note that the little dip we see at the end is many many years after thimerosal was stopped; if it were related to autism then the dip would have started years earlier.
The obvious conclusion is that vaccines containing thimerosal have nothing or at best extremely little to do with autism (and note that the MMR vaccine never contained thimerosal!). An obvious hypothesis explaining the continuing rise of cases diagnosed is that we are getting better at identifying it, and/or that the use of the term autism spectrum includes more symptoms that were previously not considered to be related.
This has not stopped the antivaccination people from marching on, however. The Washington Post is reporting that two cases trying to establish a link are being brought to court today. The article says
To win, the attorneys for the two boys, William Mead and Jordan King, will have to show that it’s more likely than not that the vaccine actually caused the injury.
This makes me very unhappy. A judge is not necessarily suited to decide medical science! If it were a case of medical ethics or negligence, or something along those lines, then certainly the judiciary system should be involved, but this is a clear-cut case of scientifically established reality. Vaccines do not cause autism.
As always in situations as delicate as these, let me say that I am a parent, and I love my daughter very much. If she had been diagnosed with some sort of issue like autism, I know I would have been devastated. I also know it is human nature to try to find a cause, some place to lay blame. But sometimes there is no blame.
I also know it’s human nature to take anything that happens after a given event and blame that event for it. I gave my daughter a vaccine, then she turned up with autistic symptoms. Therefore…
But life isn’t always like that. And I very much hope that the judges in this case are familiar with the term post hoc, ergo propter hoc: after this, therefore because of this. It’s a classic logical fallacy, and the antivax contingent is riding it right into the judicial system.
And there is a chilling side to this. Vaccines are among the greatest achievements in human history. This is not hyperbole. Millions upon millions of lives have been saved by vaccines. Smallpox is gone. Polio is gone. A vaccine has been developed to prevent HPV, saving millions of women from the horrors of cervical cancer.
If vaccinations decline, then we will see an increase in mumps, measles, rubella, whooping cough (pertussis), and many more terrible afflictions… problems that are ultimately completely curable. This is stone, cold fact. Worse, these problems are far more severe in children.
Measles kills.
Pertussis kills.
Rubella kills.
So let me make this as clear as I possibly can:
The antivaccination movement purports to try to save children. Instead, if it is successful it may be condemning millions of them to terrible ailments, and a significant fraction of them to death.
