David Kirby
Posted Friday, June 20, 2008

CDC Director Dr. Julie Gerberding has delivered a potentially explosive report to the powerful House Appropriations Committee, in which she admits to a startling string of errors in the design and methods used in the CDC's landmark 2003 study that found no link between mercury in vaccines and autism, ADHD, speech delay or tics. Gerberding was responding to a 2006 report from the National Institute of Environmental Health Sciences (NIEHS), which concluded that the CDC's flagship thimerosal safety study was riddled with "several areas of weaknesses" that combined to "reduce the usefulness" of the study. "CDC concurs," Dr. Gerberding wrote in an undated mea culpa to Congress, (provided to me through a Capital Hill staffer) adding that her agency "does not plan to use" the database in question, the Vaccine Safety Datalink, (VSD) for any future "ecological studies" of autism. In fact, Gerberding's report said, any continued use of the VSD for similar ecological studies of vaccines and autism "would be uninformative and potentially misleading."

Ecological vaccine studies are large, epidemiological analyses of risks and trends using computerized data from large populations -- in this case children enrolled at several big HMOs -- without ever examining a single patient in person. CDC officials conducted at least five separate analyses of the data over a four-year period from 1999-2003. The first analysis showed that children exposed to the most thimerosal by one month of age had extremely high relative risks for a number of outcomes, compared with children who got little or no mercury: The relative risk for ADHD was 8.29 times higher, for autism, it was 7.62 times higher, ADD, 6.38 times higher, tics, 5.65 times, and speech and language delays were 2.09 more likely among kids who got the most mercury. Over time, however, all of these risks declined into statistical insignificance, statistical inconsistency or else outright oblivion: The relative risk for autism plummeted from 7.62 in the first analysis, to 2.48 in the second version, to 1.69 in the third round, to 1.52 in the fourth, and down to nothing at all in the fifth, final, and published analysis printed in the Journal Pediatrics in November of 2003. Vaccine officials attributed the steady drop to the elimination of "statistical noise" from the data through due diligence and the endeavor for excellence in governmental statistical analysis.

Indeed, the VSD study was the main pillar of a hugely influential 2004 report by the Institute of Medicine, which also concluded that there was no evidence of link between mercury, vaccines and autism. To this day, public health officials routinely point to five "large epidemiological studies" representing the "highest quality science," none of which found any link to thimerosal. In fact, the American VSD study has long been held up as the best and brightest of them all (the others were in Sweden, the UK, and two in Denmark). And this reputation has stuck in the minds of medicine and the media.
Curiously though, even the study's lead author -- Dr. Thomas Verstraeten, an employee of vaccine maker GlaxoSmithKline -- protested that the VSD study "found no evidence against an association, as a negative study would. In fact, he said that additional study was needed, which "is the conclusion to which a neutral study must come."

That's when Congress stepped in.In 2005, a group of Senators and Representatives headed by Sen. Joe Lieberman wrote to the NIEHS (an agency of the National Institutes of Health) saying that many parents no longer trusted the CDC to conduct independent minded studies of its own vaccine program. Lieberman et al asked NIEHS to review the CDC's work on the vaccine database and report back with critiques and suggestions. The final NIEHS report was a serious and thoughtful critique of where the CDC went wrong in its design, conduct and analysis of the study. The NIEHS panel "identified several serious problems," with the CDC's effort, criticism to which the agency had not responded -- until now. In her letter to the House Appropriations Committee, the CDC Director responded directly to many -- though not all -- of the most important criticisms and recommendations contained in the NIEHS panel report.

For example, the NIEHS had criticized CDC for failing to account for other mercury exposures, including maternal sources from flu shots and immune globulin, as well as mercury in food and the environment. "CDC acknowledges this concern and recognizes this limitation," the Gerberding reply says.
The NIEHS also took CDC to task for eliminating 25% of the study population for a variety of reasons, even though this represented, "a susceptible population whose removal from the analysis might unintentionally reduce the ability to detect an effect of thimerosal." This strict entry criteria likely led to an "under-ascertainment" of autism cases, the NIEHS reported. "CDC concurs," Gerberding wrote, again noting that its study design was "not appropriate for studying this vaccine safety topic. The data are intended for administrative purposes and may not be predictive of the outcomes studied."

Another serious problem was that the HMOs changed the way they tracked and recorded autism diagnoses over time, including during the period when vaccine mercury levels were in decline. Such changes could "affect the observed rate of autism and could confound or distort trends in autism rates," the NIEHS warned.
"CDC concurs," Dr. Gerberding wrote again, "that conducting an ecologic analysis using VSD administrative data to address potential associations between thimerosal exposure and risk of ASD is not useful." Read that sentence one more time. The head of the CDC is saying that its most powerful and convincing piece of exonerating evidence for thimerosal is, in effect, "useless." I hope everyone will read it, including the recommendations to make the VSD better, and the CDC's agreement with all of the suggestions. As questionable at the US thimerosal study was, "it was an improvement on other studies, including the two in Denmark, both of which had serious weaknesses in their designs," Dr. Irva Hertz-Picciotto, Professor of Public Health at UC Davis Medical School and Chair of the NIEHS panel, told reporter Dan Olmsted at UPI.

That leaves very little for the CDC to go on in terms of proving that thimerosal and autism are not associated in any way. Yes, there is always the study of disability services data from California -- which seem to be rising among the youngest cohorts of kids, who presumably received little or no mercury because thimerosal was largely removed from childhood shots. But California is an "ecological study" with problems of its own. "Although (this) information is often used by media and research entities to develop statistics and draw conclusions, some of these findings may misrepresent the quarterly figures," cautions the website of the California Department of Developmental Services (DDS). "Increases in the number of persons reported from one quarter to the next do not necessarily represent persons who are new to the DDS system."

Even the CDC admits that "there are several limitations" with linking a VSD study design with the California data, Gerberding wrote to Congress, because, among other things, California only counts "persons who were referred to and/or voluntarily entered" the disability system." It will be interesting to see how the House Committee -- and the mainstream media -- react to this rather breathtaking confession by the CDC, which does seem to want to conduct the best vaccine-autism science possible (see Gerberding's replies to NIEHS recommendations for improving the VSD: CDC officials are currently conducting in- depth follow up studies with VSD patients). As the waning months of the Bush administration get underway, I can't help but wonder if a little housecleaning might be going on at some of our top health agencies.

Autism payout reignites vaccine controversy
From newscientist.com

JUST as the dispute over whether vaccines cause autism was dying down at last, a US government decision has added fresh fuel to the fire. Last week it emerged that the federal government is to compensate a couple who say that the regular childhood vaccines, given to their baby daughter in 2000, caused her to develop autism. Damages have not yet been set, but could exceed $1 million.

Significantly, the government's decision says nothing about whether vaccines cause autism. Instead, government lawyers concluded only that vaccines aggravated a pre-existing cellular disorder in the child, causing brain damage that included features of autism. Nonetheless, anti-vaccination campaigners are claiming vindication. "It's official," wrote one autism blogger. "The sky has fallen. The fat lady has sung. Pigs are flying." Autism experts say it is unclear why compensation is being paid. Almost 5000 other families have lodged similar claims which are being considered by the court, but decades of research have failed to find any link between vaccines and autism and few experts thought that the government would pay up.

It's unclear why compensation is being paid. Decades of research have failed to find any link between vaccines and autism. Scientists say there is nothing in the medical history of the child in question to change that thinking. "I'm stunned that they decided to settle," says Jay Gargus, a paediatrician at the University of California, Irvine. Exactly why the US government did so is still being debated, as details of the decision have been sealed and the Department of Health and Human Services won't comment.

Whatever the government's thinking, the worry is that the decision may undermine public confidence in vaccines, which is just recovering after recent scares over mercury and the measles, mumps and rubella (MMR) shot. On 29 February, for example, Republican presidential candidate John McCain used a query on the case as a chance to question whether mercury in vaccines could be linked to autism. "A decision like this will definitely make parents more wary about vaccines," says Jaime DeVille, a paediatrician at the University of California, Los Angeles, and a member of the government's childhood vaccines advisory committee.

According to internet newspaper The Huffington Post, which last week published leaked details of the court case from November, the child developed a fever after receiving scheduled vaccinations in 2000 for haemophilus influenzae, chickenpox, polio, MMR, diphtheria, pertussis, tetanus and polio, when she was 18 months old. Autism-like symptoms, such as poor communication skills, followed. In 2001 physicians concluded that the child, who has not been named, "demonstrated features of autistic disorder".

It transpired that the child's mitochondria, the powerhouses that provide cells with energy, were not working normally, and tests revealed a mutation in a gene linked to mitochondrial function. After studying her medical history, officials at the Department of Health and Human Services concluded that the vaccines had "significantly aggravated an underlying mitochondrial disorder, which predisposed her to deficits in energy metabolism", causing brain damage with "features of autism spectrum disorder".

Proponents of a link between vaccines and autism have made much of the mitochondrial disorder, in part because researchers have wondered for at least a decade whether autism could be a mitochondrial disorder. Autism runs in families and some of the genes thought to be involved play a role in mitochondrial function. Biomarkers for mitochondrial dysfunction, such as a build-up of lactic acid, are also elevated in some autistic children. David Kirby, the journalist who revealed the decision, says that in an "informal survey" of seven other children with cases pending all show signs of mitochondrial problems, though he did not reveal how he got this information.

Experts say these links do nothing to prove that autism originates in the mitochondria. "It's not surprising that mitochondrial function is abnormal," says Steven Novella, a neurologist at Yale University. "With neurodegenerative disorders almost any marker of cell health will be worse than in controls." Without more research, he adds, it is impossible to say whether the mitochondrial problems are the cause of the disease or its by-product (see "Can autism be a mitochondrial disease?"). Those who argue otherwise, are "making multiple assumptions that are not established", Novella warns.

Further complications stem from confusion over the role vaccines played in the child's condition. Severe inflammatory reactions are a rare but established side effect of vaccines, and they can damage the brain in many different ways, some of which produce symptoms similar to those seen in autism. The mitochondrial disorder might have prevented the child from dealing with her inflammation, but it is also possible that the child's mitochondrial problems caused the inflammation and that the vaccines she received were irrelevant.

Other experts added that parents should not be dissuaded from getting their children vaccinated just because of a court case. "What does this decision mean?" says Paul Offit, a paediatrician at the Children's Hospital of Philadelphia in Pennsylvania. "It doesn't mean anything. The question of whether vaccines cause autism is a scientific one, not a legal one."

Numerous scientific studies have addressed the question, adds Offit, and all concluded that there is no link. Government officials, including those at the Centers for Disease Control and Prevention in Atlanta, Georgia, also insisted the decision does nothing to change their thinking.

These caveats may, however, get lost as reaction to the decision evolves. Kevin Conway of Conway, Homer & Chin-Caplan in Boston, whose firm represents around 1200 autistic children with court cases pending, says he will start getting his clients tested for mitochondrial dysfunction. And Thomas Power, an attorney based in Portland, Oregon, says he would also like to see full details of the case, as they could help his cases of autistic children seeking compensation.

Government Concedes Vaccine-Autism Case in Federal Court - Now What?
David Kriby
February 25, 2008, from huffingtonpost.com

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. 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. But it is not.

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:

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?

6) What are the implications for research?

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?

7) What are the implications for medicine and public health?

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?

8) What are the implications for the vaccine-autism debate?

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.

9) What is the bottom line here?

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. And that is big news, no matter how you want to say it.

NOTE: Full text of the government's statement is posted here.

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

Debate Over Autism-Vaccine Link Intensifies
by Daniel J. DeNoon, WebMD
Wednesday, July 13, 2005, from foxnews.com

Sallie Bernard and Morton Ann Gernsbacher, PhD, have something in common. Each is the mother of a child with autism. Both of these mothers care deeply about their children. They care deeply about other children, too -- especially those with autism. But they could not differ more on what they think needs to be done for them. Bernard is the executive director of Safe Minds. Her organization is working hard to warn parents that mercury -- especially thimerosal, a form of mercury once used in U.S. childhood vaccines -- is the likely cause of an epidemic of autism. Gernsbacher, president elect of the American Psychological Society and professor of psychology at the University of Wisconsin-Madison, warns us not to believe in an autism epidemic. "False epidemics elicit false causes," she wrote in the April issue of Current Directions in Psychological Science.

Renewed Controversy

Last year, it looked as though the book might finally close on the vaccine/autism debate. A blue-ribbon panel convened by the independent Institute of Medicine (IOM) reviewed the evidence. It did not create many waves when it rejected the idea that the MMR (measles/mumps/rubella) vaccine might cause autism. That theory was retracted by nearly all of the researchers who originally proposed it. The IOM committee then flatly rejected the idea that vaccines containing thimerosal could cause autism. Bernard wasn't convinced. Neither was Robert F. Kennedy Jr., senior attorney for the Natural Resources Defense Council. Kennedy's recent article for Rolling Stone and Slate -- followed by a scathing Wall Street Journal editorial -- set off a flurry of public interest. Kennedy indicts thimerosal as a likely cause of autism. And he accuses the CDC, the FDA, the IOM, the World Health Organization, and the American Academy of Pediatrics of helping drug companies hide or misrepresent the evidence.What is this evidence? WebMD takes a look.

Is There Really an Autism Epidemic?

Fact: Autism rates have been going up. Recent years have seen a higher percentage of kids getting diagnosed with autism. The trend seems to have begun in the 1980s and to have picked up speed in the 1990s. Eric Fombonne, MD, FRCPsych, of the Institute of Psychiatry at King's College, London, has studied autism in the U.K. "From our data, we can say that we have a prevalence that is 62 cases per 10,000 children," he told WebMD in a 2001 interview. "In the mid-1960s, we showed rates of 4 cases per 10,000." Isn't this the sign of an epidemic? Not necessarily. "You cannot compare studies now to studies from 30 years ago," Fombonne said. "It would be comparing oranges not with apples, but with sheep."

Children with autism vary widely. It was not until 1940 that this constellation of problems with social interaction, communication, and focused interest came to be called autism. And it was not until 1980 that the diagnosis of autism was formalized. In 1994, the diagnosis changed again. Kids diagnosed with autism from 1980 through 1993 had to meet six mandatory criteria. The new 1994 definition offered 16 optional criteria, only eight of which had to be met. Gernsbacher says the 1994 diagnosis made it much easier for a child to be labeled autistic.

The federal Individuals with Disabilities Education Act, passed in 1991, assures appropriate public education for children with autism. Soon after, schools began reporting high numbers of students with autism. Those numbers keep going up. But that doesn't mean there's an autism epidemic, Gernsbacher says, any more than increased sales of petite clothing means women are getting smaller. "My hunch is that if we looked at the production and purchase of petite-sized clothing we'd see a greatly increasing trend in the number of petite-sized garments produced and purchased over the past two decades," she says. "Should we therefore conclude that U.S. women are getting increasingly more petite? Probably not. There was probably always a contingent of petite-sized women, and their needs are being increasingly better met."

Gernsbacher points to data from Fombonne and others suggesting that there are 5.8 to 6.7 autism cases among every 1,000 U.S. children. If that's so, we haven't found them all yet. Even Oregon, which led the nation with 4.3 autism cases per 1,000 children in 2002-2003, still has a way to go. Other states lag much farther behind.

Oft-Cited Study Questioned

A 2002 pilot study by the MIND Institute of the University of California, Davis, looked at the issue of whether autism rates are really getting higher -- or whether we're just getting better at finding kids with autism. Study leader Robert Byrd, MD, MPH, associate professor of clinical pediatrics at the University of California, Davis, says the study data suggest that any "loosening" of diagnostic criteria had no effect on autism rates in California. This study, despite shortcomings Byrd readily admits, is widely cited as proof that the autism epidemic is real. The MIND study compared autistic kids born in 1982-1985 to kids born in 1993-1995. Using the current criteria for diagnosis, Byrd's team found that the more recently diagnosed kids were nearly as severely autistic as those in the earlier group.

"In both groups, they on average aren't just barely meeting the threshold to be called autism -- they are almost double the threshold," Byrd tells WebMD. MIND Institute executive director Robert Hendren, DO, also defends the study findings. "This study is just one data point that exists, not the final word on the subject," Hendren says. "But based on this study, we say the increase in autism incidence is not a matter of changing diagnostic practices."

Gernsbacher says the findings are based on backward reasoning. Her main point: The study uses the current, looser definition of autism to look at children diagnosed under a more strict definition. Then it mistakenly concludes that since those kids meet the looser definition, the new definition made no difference. A 2005 study by Craig J. Newschaffer, PhD, and colleagues at the Johns Hopkins Centerfor Autism and Developmental Disabilities Epidemiology shows "a drastic increase in the prevalence of the autism classification." The study concludes that it's important to find out how much of this is due to a change in diagnosis and how much is due to "real changes in risk."

Collision: Autism Rise, Vaccine Concern

Fact: Nobody knows what causes autism. Nobody is even sure whether autism in all its different forms has one cause or many. Since autism runs in families, nearly everyone agrees there's a genetic link. Might that link be something that makes some people especially sensitive to something in the environment? One of the heartbreaking peculiarities of autism is that a child will seem to be developing normally. Then, suddenly, at age 2 to 4, everything seems to go wrong.

That's just when kids are getting their vaccinations. To many parents, a vaccine/autism link seems obvious. Until very recently, many parents believed the problem was with the measles/mumps/rubella vaccine. Although many people still cling to this idea, most have come to reject it. But until recently, many other vaccines contained a mercury-based preservative called thimerosal. Vaccines used to get contaminated with germs. Those germs killed kids. So drug companies used thimerosal to save lives. It worked.

Oddly -- for a substance given to nearly every child in the U.S. -- nobody really knew much about thimerosal. Even now, says toxicologist Thomas Burbacher, PhD, very little is known. Burbacher is associate professor of environmental and occupational health sciences and director of the infant primate research lab at the National Primate Research Center, University of Washington. "It is incredible so many millions of kids have been vaccinated with this compound with so little data on it," Burbacher tells WebMD. "But line it up with everything else. A lot of information is missing on a lot of compounds in daily use. And a lot of people thought the amount the kids were getting was so small, it was not a priority."

The Thimerosal Debate and the EPA

Thimerosal is 49 percent ethyl mercury. A closely related form of mercury, methyl mercury, is a known toxin. Since nothing was known about thimerosal, safety measures were based on what was known about methyl mercury. Everybody thought that thimerosal would be safe if the doses given to kids were below the toxic dose for methyl mercury. But three things happened. One was that kids started getting more and more vaccines containing thimerosal. Meanwhile, the U.S. Environmental Protection Agency got new information and lowered what it considered to be a toxic dose of methyl mercury. "In the 1990s, those two lines merged," Burbacher says. "Someone at the FDA noted that when you add all the vaccines up they totaled more than the new EPA standard for methyl mercury. So then the other thing that occurred, during that same time period, was an increase in rates of autism diagnosis."

By 1999, thimerosal was in 30 U.S. vaccines -- some, like the DTaP, Hib, and hepatitis B vaccines, given to infants. In July 1999, the American Academy of Pediatrics and the U.S. Public Health Service recommended removing thimerosal from vaccines. By March 2001, all vaccines recommended for U.S. children were available in thimerosal-free versions. However, the preservative is still used in multiuse vials of flu vaccines and in childhood vaccines for use in developing nations. Kids vaccinated between 1989 and 2003 are what Kennedy calls the Thimerosal Generation.

As it turns out, thimerosal is not as much like methyl mercury as previously thought. That's both good and bad, Burbacher notes. In recent monkey studies, Burbacher has found that the body eliminates thimerosal much more quickly than it eliminates methyl mercury. Thimerosal leaves two or three times less mercury in the body than methyl mercury. But Burbacher also found that thimerosal deposits something called inorganic mercury in the brain -- twice as much as from the same dose of methyl mercury. Inorganic mercury isn't supposed to do anything. But there's troubling evidence that it might -- evidence Burbacher and others are only now beginning to investigate. People who think thimerosal is safe usually point to the rapid-clearance finding. Those who think it unsafe, Burbacher says, point to the increased deposits of inorganic mercury in the brain.

The IOM as Jury

It's common, in matters of scientific dispute, to turn to the National Academy of Sciences for an answer. And when the question is medical, the dispute goes to the IOM, which then convenes a panel of nationally recognized experts to decide the matter. For thimerosal, the IOM convened these juries not once, but twice. In 2001, the first IOM committee concluded that there wasn't enough evidence to say whether thimerosal was safe or unsafe.

In 2004, the most recent committee rejected the idea that vaccines containing thimerosal cause autism. Kennedy writes that the committee findings were preordained in "secret" meetings with drug companies playing the tune. He says the committee ignored "truckloads of studies" that show thimerosal accumulates in the brains of lab animals, and he says the studies of autism trends on which the IOM relied are "disastrously flawed." "When we first heard the IOM committee was meeting, we said the meeting was premature," Safe Minds' Bernard tells WebMD. "We told them to wait, that more research is coming out. They ignored us. They went ahead and had their meeting and missed a lot of evidence."

WebMD asked committee chairwoman Marie C. McCormick, MD, ScD, to comment. McCormick is professor of maternal and child health at Harvard School of Public Health. "We had to make two kinds of assessments," McCormick tells WebMD. "One was, did we see any evidence thimerosal was associated with autism. We had five epidemiologic studies. None were perfect. But all pointed in the same direction of no association." Those five studies included five observational studies, using different methods, looking for an association between autism and vaccination in Sweden, Denmark, the U.S., and the U.K. None was found. Autism rates continued to rise even after thimerosal was removed from vaccines.

Each of the studies had flaws. But they weren't nearly as flawed as Kennedy suggests, says IOM spokeswoman Christine Stencel. "The IOM committee certainly knew of these issues and found the studies were relevant, that they were well designed, and that their data are valid," Stencel says.But what of the "truckloads" of studies to which Kennedy points? "We looked at basic science and asked if there was any indication of how thimerosal could cause autism," McCormick says. "We looked at over 200 scientific articles, and the evidence linking thimerosal to autism is purely theoretical at best."

This does not satisfy Bernard. She doesn't think the evidence proves thimerosal causes autism. But she does think the evidence points in that direction. If researchers don't follow up, she fears, valuable time will be lost. "If you assume that there is a connection between mercury exposure and an outcome of autism, then by studying what mercury does, you will come a lot closer to learning how to treat these kids," Bernard says. "And if you find a role for mercury, we can do a lot more in terms of prevention. You can't just have effective treatment -- in today's science -- without understanding the root cause."

Final Answer Coming Soon

Nearly everyone soon expects the controversy to end. One reason is that the CDC is planning a massive, definitive study. The other reason is that very soon, all the kids who got thimerosal in vaccines will have reached the ages when autism should appear -- or not. If there's no big drop in autism rates, thimerosal won't be much of an issue. Still at issue, however, is the very real threat of mercury poisoning from the environment -- a threat the world has only begun to deal with.

Advice for Parents

Meanwhile, Bernard advises parents to be informed. "I think for pregnant women or those with babies, I would have them ask their doctor for flu vaccine that does not have thimerosal in it," she says. "And I would ask them to support efforts by the government to look into what these various environmental toxins, including mercury and mercury from medical products, are doing to our children. And they should try to avoid exposures."

McCormick advises parents to look at the bottom line. "To parents, I say the risk of the wild-type diseases that are being prevented by vaccines is very, very real," she says. "You are trading the risk of these real diseases against a risk we cannot substantiate for these vaccines, which we don't have to do any more, because vaccines are now thimerosal free. If the choice must be between a thimerosal vaccine and no vaccine, take the thimerosal vaccine. But the flu vaccine is available in single dose vials without mercury. You do have a choice now."

The Mercury Calculator

Go Directly to The Calculator

Background
Thimerosal, a mercury-based preservative has been used in vaccines since the 1930's. In 1982, the FDA reviewed Thimerosal and called for its removal in over the counter products due to its' toxicity. In a review of mercury containing products in 1999, the FDA recognized that mercury exposure from vaccines exceeded federal safety guidelines set by the Environmental Protection Agency. While licensing new vaccines and adding them to the mandatory childhood schedule, the government failed to add up the amount of mercury that a child could receive in one visit and cumulatively over the course of the full vaccination regimen.

In 1999, many companies started removing Thimerosal from their products. However, some products that say they are Thimerosal free actually still contain trace amounts. Thimerosal continues to be used in some vaccines. Many of the vaccines listed in the calculator are no longer in production but are included here so you can check previous exposures.

Some neuro-developmental disorders such as autism have similar symptoms to mercury poisoning. It is well established that mercury is a neuro-toxin and is harmful to babies in utero and to the developing brains of children. There is a public health advisory from the government about the risks of eating mercury-containing seafood, but there is no public health advisory about the risks of exposure to mercury in vaccines. It is up to the individual parent to make the right vaccine choices for their children.

Using the Calculator
This mercury calculator will help you determine how much mercury a child received at previous vaccination visits or could receive in an upcoming visit. The products are listed by brand name and manufacturer. Some vaccines have two company names because over the past several decades there have been many company mergers.

Just enter the weight of the child and click on the brand name /manufacturer of the vaccine. A number will show at the top and tell you if it is over the EPA standard of 0.1 mcg per kilogram of bodyweight.

If you want to calculate your child's overall exposure to mercury containing vaccines on multiple visits, you will have to enter each visit individually, using the weight of your child at the time of the visit and then add them all together.

Many companies have merged and changed names. This is why you will see some vaccines with multiple company names. In many cases the brand name was changed when the company name changed but in some cases the brand name and company name remained the same. For example in 1999 Merck announced that their pediatric vaccine line was mercury free. Even though the mercury-free version of hepatitis B vaccine was released, the mercury-containing version remained on the market until 2002 and was never removed. We do not have the specific dates for when these changes occurred for each vaccine.

If you feel that your child is suffering the effects of mercury poisoning, please let us know by clicking here and describing the symptoms.

If you need help with identification and therapies, we suggest you contact the following organizations. Autism Research Institute and Defeat Autism Now, Developmental Delay Resources, Unlocking Autism, SafeMinds.

If you believe the information on this website has helped you learn more about the possible causes of your child's health problems or has benefited you in other ways, please consider becoming a member of NVIC. We depend upon individual donations from concerned citizens to provide this and other information about diseases and vaccines to the public.

Controversial Issue in Autism: The Measles, Mumps and Rubella (MMR) vaccine
Sheila Hollins (UK)
from www.intellectualdisability.info

The number of children diagnosed with autism is rising. What is being done to find out the causes of autism? Is the Measles, Mumps and Rubella (MMR) vaccine responsible for the increased prevalence?

The Medical Research Council's (2002) wide-ranging review of autism research outlines the current state of knowledge on the prevalence and incidence of autism. There is general agreement that the prevalence of autism is around 6 in 1,000 children under eight years of age, of whom about two thirds will also have intellectual disabilities. The review notes that the apparent increase in the prevalence of autism is likely to have resulted from better diagnosis and greater consensus regarding the defining characteristics of autism, as well as increased awareness about it. However, it points out that these factors may not account for the increase on their own.

The review confirms that many factors are associated with a diagnosis of autism. The strongest evidence to date identifies a major genetic component.
Several genes may operate together to create susceptibility to autism. It is plausible that behaviours associated with autism might be derived from a number of different genetic combinations. Further, such environmental factors as exposure to drugs, infections or heavy metals before or after birth might interact with a genetic susceptibility. Such potential links merit rigorous examination.

The report asserts that there is no evidence to support a causal link between the MMR vaccine and autism. The suggested link between the MMR vaccine, inflammatory bowel disease and autism and the issue of separate (single) vaccines has also been considered by the Government's independent expert committees i.e. the Joint Committee on Vaccines and Immunisation and the Committee on the Safety of Medicines. Their view is that, on the scientific evidence available, there is no causal link between MMR, bowel disease and autism.

The MMR vaccine has been used extensively around the world for nearly 30 years. Over 500 million doses have been given in over 90 countries.
The UK has never recommended three separate injections, and no other country is known to recommend three single vaccines rather than the MMR vaccine. Separate vaccines leave children unnecessarily at risk of infection from measles, mumps or rubella whilst waiting for the remaining vaccinations.
The recommendations regarding MMR are supported by the World Health Organisation, British Medical Association, Royal College of General Practitioners, Royal College of Paediatrics and Child Health, Royal College of Nursing and the Community Practitioners and Health Visitors Association.

New Study: Measles Vaccine Doesn't Cause Autism: Researchers hope finding will encourage parents to vaccinate children
By Nikhil Swaminathan
from Scientific American

You've probably heard the news: Measles, once banished, is back in a big way. The reason, according to the Centers for Disease Control and Prevention (CDC): children are increasingly not being vaccinated against the highly contagious virus because of fears that ingredients in the injection may cause autism, a mysterious neurological disorder that affects one out of 150 children born each year in the U.S.

But new research by Columbia University's Mailman School of Public Health did not find a connection. "We are confident that there is no link between [the measles vaccine] and autism," says lead study author W. Ian Lipkin, an epidemiologist. The researchers hope their findings, published in the journal PLoS ONE, will put the issue to rest and persuade parents to vaccinate their children—a move that could stop measles and other, previously controlled serious illnesses such as mumps and whooping cough from making comebacks.

"We need to ensure the vaccine recommendations are followed to not only protect those who are immunized," says CDC researcher Larry Pickering," but to also provide herd protection for people in the United States and throughout the world who may not be able to receive the vaccine because of their age or respond to the vaccine because of an underlying immunodeficiency."

The CDC confirmed 131 measles cases in the U.S. between Jan. 1 and Aug. 1 of this year, more than double the number of cases reported annually between 2001 and 2007. Measles causes symptoms including an extremely itchy rash, high fever, runny nose and red eyes. Children generally receive their first vaccine against it at around 15 months old. Physicians started giving the vaccine in 1963; prior to that, the virus struck three to four million Americans per year and killed 400 to 500. The CDC says that 91 percent of the current measles sufferers did not receive the shot or have evidence that they had gotten it. The major reason parents are nixing it: some studies since 1998 have indicated a possible link between the measles, mumps and rubella (MMR) vaccine and autism as well as gastrointestinal (GI) disorders. Rubella has similar symptoms to measles, but is generally milder although it can cause birth defects in fetuses of pregnant women with the disease; mumps causes high fever and painful swelling on one or both sides of the face.

One 1998 study found remnants of the measles virus in the intestines of children suffering from both autism and GI problems—estimated to be up to a quarter of the autistic population. Researchers hypothesized that the weakened measles virus used in the vaccine gathered and grew in the intestines, causing the immune system to attack, in the process damaging normal cells lining the bowels resulting in some seepage.

Such leakage could cause problems, such as abdominal pain and gastroesophageal reflux, which makes it difficult to digest food, and clear the way for the virus to enter the blood stream and travel to the brain. The new study examined children, an average of five years of age, suffering from both autism and GI problems. "Although in fact there was evidence that this vaccine was safe in the bulk of the population," Lipkin says, "it had not been previously assessed with respect to kids with autism and GI complaints."

Researchers examined cells in biopsies (from 25 children with both autism and GI problems and 13 with just GI disturbances) to determine whether they contained genetic sequences of the measles virus. They only found a detectable amount of the virus remnants in one child in each group (4 percent of the autism and GI kids, 8 percent of the GI-only tykes). This indicates that autism is not related to the MMR vaccine or to the presence of measles sequences in the intestinal tract, says Columbia epidemiologist Mady Hornig, adding that the results were replicated in three different labs. She notes that only 20 percent of the children with autism received the MMR shot before suffering GI problems and subsequent autism symptoms. "From my standpoint, [this study is] just another brick in the wall to validate the vaccine safety issue," says Walnut Creek, Calf.-based pediatrician Rahul Parikh, who often counsels worried parents about the importance of vaccinating their children. "We still have parents coming in with a lot of concerns."

Rick Rollens, who has an autistic son who suffers from a "horrible bowel disorder," called the new research sound science and praised it for calling attention to an underserved subset of the autism spectrum: those children who also suffer from GI problems. But he insists that it does not give the all clear to all vaccines. "I'm totally convinced that a vaccine caused the autism my child suffers from," Rollens says. "This study by itself does not exonerate the role of all vaccines"—only the MMR.

Vaccination: Why Parents Are Opting Out
By Liza Featherstone
from babble.com, May 26, 2007

People who don't vaccinate their kids tend to talk in these terms. They used to be passive "sheeple," doing what the doctors and the experts told them. Once they informed themselves, they realized the full horror of injecting helpless infants full of toxins. Kristen Monaghan, a stay-at-home mother in Manhattan's Gramercy neighborhood whose husband works in asset management, recalls that with her first child, Rubin (now twenty-one months), "I was afraid to educate myself." But when she was expecting her second, August, Kristen and her husband attended a talk by Dr. Larry Palevsky, a local anti-vaccine activist and As recently as our parents' generation, it was not unusual to see kids in wheelchairs or iron lungs: polio survivors.pediatrician. Kristen's husband was reluctant to go, assuming that Kristen was worrying needlessly. But she says that, during the break in the lecture, "We turned to each other and said, 'We've been such idiots.'"
Unlike many anti-vaccine activists, Dr. Palevsky comes across in conversation as a reasonable person. He talks about data and scientific "literature," not about government plots and cover-ups. "Parents become convinced," he explains, "that the risk of illness is worse than the risk of the vaccine. But there's no data to support that statement. There are no studies of the long-term effect of vaccinations." He later adds that there are no studies looking at the "real short-term effects of vaccinations, either." It is, of course, these kinds of statements that parents find most terrifying.

They're also pretty misleading; the Centers for Disease Control has a system in place to rigorously track what it calls "adverse events" associated with vaccinations, and does in fact study the patterns. For most of the vaccines currently used, severe adverse reactions — coma, brain damage, death — have been reported in less than one in a million children, according to the CDC, so rarely that it is usually difficult to know whether the vaccine even caused the problem. Compare that with the risks associated with the diseases themselves. The HIB (Haemophilius influenzae) vaccine prevents bacterial meningitis. Before that vaccine's introduction in 1987, about one in 200 children under five in the United States got Hib meningitis every year, and 600 died of it, while others were left mentally retarded or deaf. Now that people are immunized, incidence of Hib has declined by 98%. As recently as our parents' generation, it was not unusual to see kids in wheelchairs or iron lungs: polio survivors. Indeed, 13,000-20,000 cases of paralytic polio were reported each year before the shot was introduced in 1955. Now, polio has been eliminated not only in the United States, but the entire western hemisphere.

While research has found that too much mercury — in fish, for instance — can cause some cognitive problems for children, there is, according to an exhaustive 2004 study by the Institute of Medicine, no evidence of a connection between mercury and autism. Indeed, in Denmark, autism rates increased after thimerosal was removed from vaccines. Still, as a result of widespread parent concerns about thimerosal, the vaccines that babies now receive contain very little mercury (a measure that the Centers for Disease Control took mainly to restore public confidence in vaccines). But the vaccine-autism connection still has vocal adherents — including some parents of autistic children, as well as activists who oppose vaccines for their own ideological reasons — and continues to be aired in media reports as a possibility. "His father claims Alex wasn't autistic — until he got certain vaccinations containing a mercury preservative," reads one of untold scores of recent articles and news programs that give the views of concerned parents and medical experts equal weight.  

Lorena, another Manhattan mother, also decided after hearing Dr. Palevsky speak, that "the body can take care of itself."Will this army of skeptics shake the foundation of mandatory shots? (She asked that her last name be withheld. "Dr. Palevsky made me paranoid," she explains, citing "stories of parents being pursued by the state.") Lorena, who has a one-year-old, does not trust drug companies: "I think they are unethical. Look what they're trying to do now [with the HPV vaccine] — make it mandatory for fifth and sixth grade girls to be vaccinated for a sexually transmitted disease! They're going to hell." She brings up the — certainly disgraceful — history of pharmaceutical companies testing dangerous drugs on people in the Third World. Like many anti-vaccinators, Lorena also believes that vaccines are weakening our immune systems. Will this army of skeptics shake the foundation of mandatory shots? Is my playgroup hostess correct in her predictions of mass revolt? It's unlikely that the public health establishment will so easily give up universal vaccination — which has, many doctors agree with Dr. Bernstein, saved more lives than any other single innovation (with the possible exception of the decline in cigarette smoking). But my hostess is right about one thing: she's not alone in choosing not to vaccinate her child.

Though parents who don't vaccinate have usually done mountains of research, and are fluent in the language of evidence and science, they'll often admit that their decision isn't ultimately about the facts. Says Lorena, "my gut tells me. I just know that I will not vaccinate my child." A pediatrician in the Northeast who blogs anonymously on these issues — and accepts non-vaccinators in his practice — tells me that worried inquiries from parents about the autism link have increased, probably because of media coverage. Some people do have bad reactions to vaccines, this doctor acknowledges, "but hysteria is never a good thing. And we're at near-hysteria right now." Why now? Partly because, although there have been vaccine skeptics for as long as there have been vaccines, they tend to be most vocal when major childhood diseases are in retreat (not many Africans are worrying about autism right now). Side effects from vaccines are not unknown, of course, and since few of us know anyone who has had a vaccine-preventable disease, more and more parents question the risk. Diseases like polio, says Dr. Bernstein, are "out of sight, out of mind, so many parents may not feel the need to have their children vaccinated." In its current form, vaccine resistance bears the familiar markers of Generation X parenthood. Attachment parenting has, for many of us, created a kind of cult of personality around ourselves, in which we alone know what's best for our children. We also fetishize our emotional bond with our kids as sacrosanct yet weirdly fragile. Jo Rendell and Brad Lewis, a Greenwich Village couple (a novelist and NYU professor, respectively), have allowed their three-year-old, Bennie, to have some shots but have avoided others. They eschew "Well Baby" visits, because, as Jo puts it, "We know when he's sick." Brad — a psychiatrist — explains their resistance to vaccinating Bennie in part as a psychic one: "We were just building a rapport with him, a sense of trust. We had no language to explain to him what was going on." Jo agrees: "We intuited that it would be traumatic for him."

Buy Buy Baby: How Consumer Culture Manipulates Parents and Harms Young Minds, this generation of parents is anxious not to be taken for dupes, yet our skepticism can be superficial and capriciously directed. We are often, as Arthur Allen points out in his new book Vaccine, more willing to believe a random article on the internet than scientists who have spent their lives studying vaccines. Many of us have been oddly credulous about the anti-vaccine activists, some of whom are charlatans who make Merck look like the Boys & Girls Club. In addition to serving the worthy purpose of reminding us that every medical intervention has risks, many of these characters have terrified parents with vaccine fears that are simply ridiculous, in one case evoking the possibility of "brain-eating bugs." Some anti-vaccinators have even made a career of providing expert-witness testimony to defend defendants in "shaken baby" cases, claiming that the children's injuries come not from abuse but from shots.

Several parents interviewed for this article were particularly disturbed by the number of vaccines given to today's newborns. Indeed, babies do get more shots now than we did when we were kids. Several new vaccines were added in the 1990s, and that's clearly part of the reason so many people are up in arms. Some parents, while committed to the concept of vaccination, are now worried enough about potential side effects — or bad interaction between vaccines — that they are asking to have the shots spaced out. Many follow some version of the schedule devised by Stephanie Cave, vaccine skeptic and author of What Your Doctor May Not Tell You About Vaccinations — often giving children just one shot at a time. Plenty of pediatricians are willing to accommodate patients who do this — though few willThe state of the health-care system may be contributing to the anti-vaccine revolt. present the option up front. Other parents staking out a middle ground on the issue have rejected only the chicken-pox vaccination (this, too, is a choice that many pediatricians accommodate). There are some reasonable justifications for opting out of the chicken-pox shots: for most children, chicken pox isn't a serious illness, and getting it as a kid may provide greater immunity in adulthood, when it's often more dangerous. The state of the health-care system, especially the fact that so many people receive care through impersonal HMOs, may also be contributing to the anti-vaccine revolt. Dr. Palevsky and Dr. Bernstein don't agree on much, but both think that people are much more likely to be skeptical of vaccines if they don't have a strong relationship with their doctor.

Unlike most parents who are not vaccinating, Kristen Monaghan does recognize that her choice could be seen as ethically questionable. After all, non-vaccinators don't expose their own children to the potential dangers of vaccines, yet because most parents in their community probably do, unvaccinated kids are often not in much danger of contracting serious diseases. "I feel sort of guilty — since most of our friends [vaccinate], our kids are safe," she acknowledges. "But, not guilty enough to get my kid vaccinated!" She does acknowledge the selfishness of her decision: "If the majority of us didn't do it, who knows what diseases would come back?" Then she dismisses her guilt: "We don't know what would happen — maybe it would be fine." Other parents interviewed for this article seemed not to have considered the possibility that they could be free-riding on the system. Brad sees in the very question a "difficulty with difference — why can't there be different strokes?" Like many vaccine skeptics, Brad and Jo believe that serious diseases were in retreat before vaccines, because of improved sanitation, and that the threat belongs to history.

But why would parents think collectively? The social contract is, in many ways, failing us. High-quality day care, for example, is expensive; a year at one well-regarded center on the Upper West Side of Manhattan costs nearly as much as my entire college education. Regina Chiu, an Upper West Sider who is vaccinating her baby but following the slower schedule influenced by Stephanie Cave's book, admits, "I might have made a different decision if he were in day care." (Her child is relatively safe from infectious diseases, because he doesn't interact with many other children.) In many places, public schools are not great. Health insurance coverage for families is Deciding to vaccinate isn't like deciding whether to circumcise, home-school, baptize or give your child a silly name.increasingly expensive. Most companies don't provide day care or a decent amount of family leave time. Since society isn't doing much to help us take care of our kids, many of us conclude that we are, as Judith Warner suggests in Perfect Madness: Motherhood in the Age of Anxiety, on our own. Plenty of us respond by pretending we're raising our children in a bubble. While that's understandable, it's not sensible. By not vaccinating, we're rejecting one of the few effective things that our society has done for children, and undermining a collective effort to keep everyone safe.

McCain Supports Parental Vaccine Choice. McCain Addresses Vaccine Safety
By Rebecca Estepp, Oct. 23, 2008

I'm a registered independent voter. Since autism blew into my life with the diagnosis of my son, Eric, I no longer subscribe to either party. Autism affects the children of Democrats and Republicans equally. Autism affects Americans.

My party affiliation is now autism/vaccine safety. While there are many other issues facing our country today - our economy, global warming, alternative energy and fighting two wars among them- autism/vaccine safety is my issue. For the 2008 election, I am a one-issue voter, and I am not alone. Many voters are concerned about vaccine safety. As the wife of a Marine who has served three war-time deployments overseas over the last five years, you would think the war would be the most important issue to me, but it's not.

This war will be over at some point, but the effects of vaccine damage will last for generations. I am extremely concerned about babies that are being injected on a daily basis with neurotoxins that are causing countless medical conditions and stealing their potential for a full life. It weighs heavily on my heart.

This is the precise reason I took it upon myself to challenge the Presidential Candidates to issue two executive orders that, if implemented, would begin to address vaccine safety.

After months of hard work, I am pleased to report that, on Monday night, I received an e-mail response to my questions from Douglas Holtz -Eakin, a senior policy advisor to the McCain campaign.

The McCain campaign directly responded to my request with the following two key points:

1) Vaccine safety is a concern. He "will work with all agencies to take all necessary steps in an expedient manner to ensure safe vaccines for every American family." This will include continuing work to reduce and eliminate thimerosal (containing the known neurotoxin mercury) from vaccines.
2) Parental choice is paramount. "The key to health care reform is to restore control to the patients themselves."