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Sunday, May 25, 2008

Post #7 The Vaccine Controversy

An excellent article covering the controversy over vaccines and autism. I have 3 children and they are all following the A.C.I.P. immunization schedule. They are all healthy and doing well. . . slightly mischievous, but healthy!

VACCINES & AUTISM: Myths and Misconceptions
The Anti-Vaccination Movement
Despite the growing scientific consensus that vaccines are safe and that neither vaccines nor mercury cause autism, a stubborn vocal minority claims otherwise, threatening the effectiveness of this public health program.


Steven Novella, MD, is an assistant professor of neurology at Yale University School of Medicine. He is the host of The Skeptics’ Guide to the Universe, a weekly science podcast (, author of the NeuroLogica blog ( NeuroLogicaBlog), and president of the New England Skeptical Society


Michelle Cedillo has autism, which her parents believe is the result of her childhood vaccines. In June 2007 they had the opportunity, along with eight other families, to make their case to the Autism Omnibus—a U.S. Court of Federal Claims that was presided over by three “special masters” appointed for the purpose. These nine cases are the first test cases that will likely determine the fate of 4,800 other claims made over the past eight years for compensation for injuries allegedly due to childhood vaccines.

Vaccines are one of the most successful programs in modern health care, reducing, and in some cases even eliminating, serious infectious diseases. Public support for the vaccination program remains strong, especially in the United States where vaccination rates are currently at an all-time high of >95 percent (CDC 2004). Yet, despite a long history of safety and effectiveness, vaccines have always had their critics: some parents and a tiny fringe of doctors question whether vaccinating children is worth what they perceive as the risks. In recent years, the anti-vaccination movement, largely based on poor science and fear-mongering, has become more vocal and even hostile (Hughes 2007).

Of course, vaccines are not without risk (no medical intervention is), although the benefits far outweigh those risks. Because vaccines are somewhat compulsory in the United States—although opting out is increasingly easy—a National Vaccine Injury Compensation Program was established to streamline the process for compensation for those who are injured due to vaccines (USDOJ 2007). It is this program to which the Cedillo and 4,800 other families are applying for compensation.

In the last decade, the anti-vaccine movement, which includes those who blame the MMR (mumps-measles-rubella) vaccine for autism, has largely merged with those who warn that mercury toxicity is the cause of many of the ills that plague mankind. The two groups have come together over the issue of thimerosal, a mercury-based preservative in some vaccines. They believe that it was the use of thimerosal in childhood vaccines that led to the apparent autism epidemic beginning in the 1990s.

Autism is a complex neurological disorder that typically manifests in the first few years of life and primarily involves a deficiency of typical social skills and behavior. In the 1990’s, the number of autism diagnoses significantly increased, from between one and three to about fifteen cases per ten thousand, although the true incidence is probably between thirty and sixty per ten thousand (Rutter 2005). During this same period, the number of vaccines given in the routine childhood schedule also increased. This led some to assume, or at least speculate, causation from correlation—perhaps the vaccines or something in them created this “epidemic” of autism.

We can now say, from multiple independent lines of evidence, that vaccines do not cause autism. For one thing, the autism “epidemic” probably does not represent a true increase in the disorder, but rather an artifact of expanding the diagnosis (now referred to as autism spectrum disorder, ASD) and increased surveillance (Taylor 2006).

In 1998, researcher Andrew Wakefield and some of his colleagues published a study in the prestigious English medical journal Lancet that claimed to show a connection between the MMR vaccine and autism (Wakefield 1998). Wakefield’s theory was that the MMR vaccine, which contains a live virus, can cause in susceptible children a chronic measles infection. This in turn leads to gastrointestinal disturbances, including what he calls a “leaky gut” syndrome, which then allows for certain toxins and chemicals, like those from bread and dairy that are normally broken down by the gut, to enter the bloodstream where they can access and damage the developing brain.

Although the study was small and the evidence was considered preliminary, this article sparked a firestorm. As a result of the study and the media coverage that followed (and continues to this day), MMR compliance in Great Britain plummeted, resulting in a surge of preventable disease (Friederichs 2006).

Subsequent to the seminal article in the Lancet, many follow-up studies were performed testing the autism-MMR vaccine correlation. As the follow-up studies began to be published, however, it became increasingly clear that there was no link between MMR and autism. For example, a study in the British Medical Journal found that autism rates continued to climb in areas where MMR vaccination rates were not increasing (Taylor 1999). Another study found no association with MMR and autism or GI (gastrointestinal) disorders (Taylor 2002). Other studies showed no difference in the diagnosis rate of autism either before or after the MMR vaccine was administered (Honda 2005), or between vaccinated and unvaccinated children (Madsen 2002). Most recently, a study found that there was no decrease in autism rates following removal of the MMR vaccine in Japan (Honda 2005).

In 2001, the Institute of Medicine (IOM) reviewed all of the MMR-autism data available to date and concluded that there was no association and essentially closed the case (IOM 2001)—a conclusion confirmed by still later studies, such as the Honda study in Japan cited above.

If Wakefield had simply been wrong in his preliminary findings, he would be innocent of any wrongdoing—scientists are not faulted if their early findings are not later vindicated. However, in May 2004, ten of Wakefield’s co-authors on his original paper withdrew their support for its conclusions. The editors of Lancet also announced that they withdrew their endorsement of the paper and cited as part of the reason an undisclosed potential conflict of interest for Wakefield, namely that at the time of its publication he was conducting research for a group of parents of autistic children seeking to sue for damages from MMR vaccine producers (Lancet 2004).

It gets worse. Investigative reporter Brian Deer has uncovered greater depths to Wakefield’s apparent malfeasance. Wakefield had applied for patents for an MMR vaccine substitute and treatments for his alleged MMR vaccine-induced gut disorder (Deer 2007). So, not only was he allegedly paid by lawyers to cast doubt on the MMR vaccine, but he stood to personally gain from the outcome of his research.

Andrew Wakefield. (Credit: Tom Miller) [Photo via Newscom]

Further, during the Cedillo case testimony, Stephen Bustin, a world expert in the polymerase chain reaction (PCR), testified that the lab Wakefield used to obtain the results for his original paper was contaminated with measles virus RNA. It was therefore likely, Bustin implied, that the PCR used by Wakefield was detecting this contamination and not evidence for measles infection in the guts of children with autism who had been vaccinated, as Wakefield claimed. And finally, Nicholas Chadwick testified that the measles RNA Wakefield found matched the laboratory contamination and did not match either any naturally occurring strain or the strain used in the MMR vaccine—a fact of which he had informed Wakefield (USCFC 2007).

All of this, plus other allegations still coming out, has caused Britain’s General Medical Council to call Wakefield before its “Fitness to Practise” panel for review of his alleged professional misconduct (GMC 2007).

Believers in the MMR-autism hypothesis dismiss the findings of the larger and more powerful epidemiological studies that contradict a link. Instead, they have turned Andrew Wakefield into a martyr, dismissing the evidence of his wrongdoing as a conspiracy against him designed to hide the true cause of autism from the public. Wakefield is unrepentant and maintains his innocence (Gorski 2007).

With the MMR-autism hypothesis scientifically dead, attention soon shifted to thimerosal, a mercury-based preservative found in some childhood vaccines (although not the MMR vaccine). There is little doubt, and no controversy, that mercury, the major component of thimerosal, is a powerful neurotoxin, or poison to the brain. However, toxicity is always a matter of dose. Everything becomes toxic in a high enough dose; even too much water or vitamin C can kill you. So the real question is whether the amount of mercury given to children in vaccines containing thimerosal was enough to cause neurological damage.

Author of the book Evidence of Harm: Mercury in Vaccines and the Autism Epidemic David Kirby (center) speaks as president Harvey Fineberg (left) of the Institute of Medicine listens during an interview by moderator Tim Russert (right) on NBC’s Meet the Press August 7, 2005, at the NBC studios in Washington, D.C. Fineberg and Kirby talked about the rising number of autism diagnoses among children and the controversial charges of a government conspiracy to allow mercury exposures from childhood vaccines to more than double between 1988 and 1992. The Institute of Medicine reviewed all MMR-autism data and concluded that there was no association. (Photo by Alex Wong/Getty Images for Meet the Press) [Photo via Newscom]

Proponents of the mercury hypothesis argue that the ethylmercury found in thimerosal was given in doses exceeding Environmental Protection Agency limits. This load of mercury should be considered with prenatal vaccine loads possibly given to mothers, and to other environmental sources of mercury, such as seafood. Furthermore, underweight or premature infants received a higher dose by weight than larger children. Some children, they argue, may have a specific inability to metabolize mercury, and perhaps these are the children who become autistic.

Fear over thimerosal and autism was given a huge boost by journalist David Kirby with his book Evidence of Harm (Kirby 2005). Kirby tells the clich├ęd tale of courageous families searching for help for their sick children and facing a blind medical establishment and a federal government rife with corruption from corporate dollars. Kirby echoes the core claim that as the childhood vaccine schedule increased in the 1990s, leading to an increased cumulative dose of thimerosal, autism diagnoses skyrocketed.

In the end, Evidence of Harm is an example of terrible reporting that grossly misrepresents the science and the relevant institutions. As bad as Kirby’s position was in 2005, in the last two years the evidence has been piling up that thimerosal does not cause autism. Rather than adjusting his claims to the evidence, Kirby has held fast to his claims, which has made him a hero alongside Wakefield of the mercury-autism-connection crowd as he has squandered his credibility.

There have now been a number of epidemiological and ecological studies that have all shown no correlation between thimerosal and autism (Parker 2004 and Doja 2006). I have already mentioned that the current consensus holds that there is no real autism epidemic, just an artifact of how the diagnosis is made. If there’s no epidemic, there’s no reason to look for a correlation between thimerosal and autism. This has been backed up by The Institute of Medicine, which has also reviewed all the available evidence (both epidemiological and toxicological) and concluded that the evidence does not support the conclusion that thimerosal causes autism (IOM 2004).

Especially damning for the thimerosal hypothesis are the recent studies that clearly demonstrate that early detection of autism is possible long before the diagnosis is officially made. Part of the belief that vaccines may cause autism is driven by the anecdotal observation by many parents that their children were normal until after they were vaccinated—autism is typically diagnosed around age two or three. However, more careful observations indicate that signs of autism are present much earlier, even before twelve months of age, before exposure to thimerosal (Mitchell 2006). In fact, autism expert Eric Fombonne testified in the Autism Omnibus hearings that Michelle Cedillo displayed early signs of autism clearly visibly on family video taken prior to her receiving the MMR vaccine (USCFC 2007).

Meanwhile, evidence is accumulating that autism is largely a genetic disorder (Szatmari 2007). This by itself does not rule out an environmental factor, but it is telling that genetic research in autism has proven so fruitful.

Mercury alarmists, in the face of this negative evidence, have been looking for rationalizations. Some have argued that the thimerosal in prenatal vaccines may be to blame, but recent evidence has shown a negative correlation there as well (Miles 2007).

What we have are the makings of a solid scientific consensus. Multiple independent lines of evidence all point in the same direction: vaccines in general, and thimerosal in particular, do not cause autism, which rather likely has its roots in genetics. Furthermore, true autism rates are probably static and not rising.

A demonstrator carries a sign protesting the use of mercury in vaccines past the U.S. Capitol in Washington July 20, 2005. Some three hundred people marched demanding that mercury not be used in vaccines anymore amid concern that it is the cause of autism and other neurological diseases in children. However, numerous studies show no correlation between Thimerosol and autism. (Nicholas Kamm/AFP/Getty Images) [Photo via Newscom]

The only researchers who are publishing data that contradicts this consensus are the father-and-son team of Mark and David Geier. They have looked at the same data and concluded that thimerosal does correlate with autism. However, the hammer of peer-review has come down on their methods and declared them fatally flawed, thus rendering their conclusions invalid or uninterpretable (Parker 2004). Also, like Wakefield, their reputations are far from clean. They have made something of a career out of testifying for lawyers and families claiming that vaccines caused their child’s autism, even though the Geiers’ testimony is often excluded on the basis that they lack the proper expertise (Goldacre 2007). The Geiers were not even called as experts in the Autism Omnibus hearings.

The Geiers are now undertaking an ethically suspect study in which they are administering chelation therapy to children with autism in conjunction with powerful hormonal therapy allegedly designed to reduce testosterone levels. Chelation therapy removes mercury, and so it is dependent upon the mercury hypothesis, which is all but disproved. Moreover, there is no clinical evidence for the efficacy of chelation therapy. The treatment is far from benign and is even associated with occasional deaths (Brown 2006).

With the scientific evidence so solidly against the mercury hypothesis of autism, proponents maintain their belief largely through the generous application of conspiracy thinking. The conspiracy claim has been made the loudest by Robert F. Kennedy Jr. in two conspiracy-mongering articles: Deadly Immunity published on in 2005 (Kennedy 2005), and more recently Attack on Mothers (Kennedy 2007). In these articles, RFK Jr. completely misrepresents and selectively quotes the scientific evidence, dismisses inconvenient evidence as fraudulent, accuses the government, doctors, and the pharmaceutical industry of conspiring to neurologically damage America’s children, and accuses scientists who are skeptical of the mercury claims of attacking the mothers of children with autism.

Despite the lack of evidence for any safety concern, the FDA decided to remove all thimerosal from childhood vaccines, and by 2002 no new childhood vaccines with thimerosal were being sold in the U.S. This was not an admission of prior error, as some mercury proponents claimed; instead, the FDA was playing it safe by minimizing human exposure to mercury wherever possible. The move was also likely calculated to maintain public confidence in vaccines.

This created the opportunity to have the ultimate test of the thimerosal autism hypothesis. If rising thimerosal doses in the 1990s led to increasing rates of autism diagnosis, then the removal of thimerosal should be followed within a few years by a similar drop in new autism diagnoses. If, on the other hand, thimerosal did not cause autism, then the incidence of new diagnoses should continue to increase and eventually level off at or near the true rate of incidence. In 2005, I personally interviewed David Kirby on the topic, and we both agreed that this would be a fair test of our respective positions. Also, in an e-mail to science blogger Citizen Cain, Kirby wrote, “If the total number of 3-5 year olds in the California DDS [Department of Developmental Services] system has not declined by 2007, that would deal a severe blow to the autism-thimerosal hypothesis” (Cain 2005).

Well, five years after the removal of thimerosal, autism diagnosis rates have continued to increase (IDIC 2007). That is the final nail in the coffin in the thimerosal-vaccine-autism hypothesis. The believers, however, are in full rationalization mode. David Kirby and others have charged that although no new vaccines with thimerosal were sold after 2001, there was no recall, so pediatricians may have had a stockpile of thimerosal-laden vaccines—even though a published inspection of 447 pediatric clinics and offices found only 1.9 percent of relevant vaccines still had thimerosal by February 2002, a tiny fraction that was either exchanged, used, or expired soon after (CDCP/ACIP 2002).

Those who argue for the link have put forth increasingly desperate notions. Kirby has argued that mercury from cremations was increasing environmental mercury toxicity and offsetting the decrease in mercury from thimerosal. The Geiers simply reinterpreted the data using bad statistics to create the illusion of a downward trend where none exists (Geier 2006). Robert Kennedy Jr. dodges the issue altogether by asking for more studies, despite the fact that the evidence he asks for already exists. He just doesn’t like the answer. Kennedy and others also point to dubious evidence, such as the myth that the Amish do not vaccinate and do not get autism. Both of these claims are not true, and the data RFK Jr. refers to is nothing more than a very unscientific phone survey (Leitch 2007).

The Autism Omnibus hearings have concluded, and while we await the decision due early next year, I am optimistic that science and reason will win the day. Just as shown in the 2005 Dover trial of intelligent design where the full body of scientific evidence was given a thorough airing in court and subjected to rules of evidence and the critical eyes of experienced judges, science tends to win out over nonsense. By all accounts, the lawyers for those claiming that vaccines caused their children’s autism put on pathetic performances with transparently shoddy science, while the other side marshaled genuine experts and put forth an impressive case.

But the stakes are high, and not just for the 4,800 families. If the petitioners win these test cases despite the evidence, it will open the floodgates for the rest of the 4,800 petitioners. This will likely bankrupt the Vaccine Injury Compensation Program and will also risk our vaccine infrastructure. Pharmaceutical companies will be reluctant to subject themselves to the liability of selling vaccines if even the truth cannot protect them from lawsuits.

Thimerosal still exists as a necessary preservative in multi-shot vaccines outside the United States, especially in poor third-world countries that cannot afford stockpiles of single-shot vaccines. Anti-thimerosal hysteria therefore also threatens the health of children in poor countries.

And of course a victory for the anti-vaccination activists would undermine public confidence in what is arguably the single most effective public health measure devised by modern science. This decrease in confidence will lead, as it has before, to declining compliance and an increase in infectious disease.

The forces of irrationality are arrayed on this issue. There are conspiracy theorists, well-meaning but misguided citizen groups who are becoming increasingly desperate and hostile, irresponsible journalists, and ethically compromised or incompetent scientists. The science itself is complex, making it difficult for the average person to sift through all the misdirection and misinformation. Standing against all this is simple respect for scientific integrity and the dedication to follow the evidence wherever it leads.

Right now the evidence leads to the firm conclusion that vaccines do not cause autism. Yet, if history is any guide, the myth that they do cause autism will likely endure even in the face of increasing contradictory evidence.

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1 comment:

Anonymous said...

Good summary. Attacking vacines has become an industry.