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Government rules in favor of child whose parents claim vaccines caused her autism

February 27, 2008. There are some 4,900 cases involving claims that vaccines caused autism now pending before the Division of Vaccine Injury Compensation, Department of Health and Human Services (DVIC). A few test cases have been brought before a special federal court (presided over by three Special Masters, described in some detail by Orac.). The first decision in those cases was handed down last November and was posted on the Huffingtonpost website by David Kirby, author of Evidence of Harm - Mercury in Vaccines and the Autism Epidemic, A Medical Controversy (2005). Kirby is an impassioned advocate for the vaccines-cause-autism camp. He's hardly disinterested and likes to use assuring expressions like "all decent people can agree" (so you don't need to think about this). Nevertheless, he says he obtained a copy of the decision "through individuals unrelated to the case," which had been "sealed to protect the plaintiff's identify." Kirby thinks every American should read the decision because he thinks it is a step in the direction that will ultimately end in some sort of concession to the notion that vaccines are a significant causal factor in the development of some cases of autism. He must also think that most people who read it will conclude something along the lines of his own thinking. His headline reads: Government Concedes Vaccine-Autism Case in Federal Court - Now What? I read the court document. Kirby doesn't have it exactly right. No diagnosis of autism was made in the case and the ruling does not claim that there is a link between vaccines and autism. The decision may have some legal significance but the evidence presented in this case to support a causal connection between vaccines and any disorder is meager, and hinges on future research establishing that in some people their mitochondrial DNA predisposes them to react to something in vaccines that causes some sort of symptoms that are consistent with autism spectrum disorder. In short, the data indicate we are a long way from Kirby's conclusion.

The facts of the case, decided in favor of the plaintiff, are undisputed:

--The child, referred to as a female in the decision, was born in December 1998.

--The pregnancy was complicated by gestational diabetes.

--From January 26, 1999 through June 28, 1999, the child was seen by a pediatrician for minor complaints, including fever and eczema.

--At seven months of age, she was diagnosed with bilateral otitis media [ear infection] and for the next six months had frequent bouts of otitis media. She was treated with multiple antibiotics and received PE tubes in January 2000.

--Her mother did not allow her to receive the standard 12 and 15 month childhood immunizations.

--On July 19, 2000, she received five vaccinations - DTaP, Hib, MMR, Varivax, and IPV.  According to her mother's affidavit, the child developed a fever of 102.3 degrees two days after her immunizations and was lethargic, irritable, and cried for long periods of time. [Note: "Fever is ... a frequently reported adverse event following immunization."]

--According to her mother, the child exhibited intermittent, high-pitched screaming, back-arching, and a decreased response to stimuli over a period of ten days and she says that her pediatrician told her that the child was having a normal reaction to her immunizations.

--On July 31, 2000, the child was diagnosed with a post-varicella vaccination rash.

--Two months after the vaccinations, on September 26, 2000, she had a temperature of 102 degrees, diarrhea, nasal discharge, a reduced appetite, and was pulling at her left ear.

--Two days later, on September 28, 2000, she had diarrhea,  was congested, and her mother reported that she was crying during urination.

--On November 1, 2000, she received bilateral PE tubes.

--On November 27, 2000, she was seen at the Pediatric Center with complaints of diarrhea, vomiting, diminished energy, fever, and a rash on her cheek.

--On December 14, 2000, the doctor noted that she had a possible speech delay.

Soon the child was having speech and balance problems. Her ear problems continued. Then, on February 8, 2001, Dr. Andrew Zimmerman reported that after the child's immunizations of July 19, 2000, an "encephalopathy progressed to persistent loss of previously acquired language, eye contact, and relatedness." It is not clear where he got this information, but apparently the first time he saw the child was six months after she was vaccinated. He diagnosed the child with "regressive encephalopathy with features consistent with an autistic spectrum disorder, following normal development." According to the court, "laboratory studies strongly indicated an underlying mitochondrial disorder."

Dr. Richard Kelley, a specialist in neurogenetics, examined the child on May 22, 2001, and "affirmed that the child's history and lab results were consistent with 'an etiologically unexplained metabolic disorder that appear[ed] to be a common cause of developmental regression'." According to Kelley, "children with biochemical profiles similar to [the child in this case] develop normally until sometime between the first and second year of life when their metabolic pattern becomes apparent, at which time they developmentally regress." He calls the condition "mitochondrial PPD." The diagnosis was confirmed by another doctor.

Unfortunately, the child now suffers seizures in addition to her other problems. According to Kirby, on February 22, 2008, the Department of Health and Human Services declared that the seizures were caused by vaccines. The ruling last November stated: "DVIC has concluded that CHILD’s complex partial seizure disorder, with an onset of almost six years after her July 19, 2000 vaccinations, is not related to a vaccine-injury." I have no idea why there was a change of finding regarding the claim that the vaccines caused the seizures. It is doubtful any new scientific evidence was discovered in the last three months. Perhaps this was conceded by the government in exchange for some concession on the part of the plaintiffs.

I have no idea what reasoning was used by the medical personnel at the Division of Vaccine Injury Compensation who concluded from the above facts that vaccines caused this poor child's array of medical problems, including her seizures.* The child has a disorder that affects every cell in her body and it is pure speculation at this point that the vaccines either caused the mitochondrial PPD or in any way caused her autistic-like symptoms or seizures. Nevertheless, the DVIC "concluded that the facts of this case meet the statutory criteria for demonstrating that the vaccinations CHILD received on July 19, 2000, significantly aggravated an underlying mitochondrial disorder, which predisposed her to deficits in cellular energy metabolism, and manifested as a regressive encephalopathy with features of autism spectrum disorder." Notice that the ruling does not say the vaccines caused autism. In fact, the ruling doesn't even say that the child was ever diagnosed with autism. She shows "features of autism spectrum disorder." This may seem like a fine point but there is a big difference between, say, "features of depression" and "depression." In any case, none of the doctors who examined the child and who are mentioned in the court's decision diagnosed her with autism.

I don't know what the statutory criteria are but it is obvious that they are not identical to the criteria sound science would require to establish a causal connection. [According a lawyer quoted in the Washington Post, the legal standard of plausibility is "50 percent and a feather," whatever that means.] From a scientific point of view, what you have is the post hoc fallacy against a backdrop of overwhelming evidence that vaccines do not cause autism. It bears repeating: nobody diagnosed the child with autism. She manifests symptoms that are consistent with autism spectrum disorder. Did the vaccines cause her ear infections or the diarrhea and vomiting that occurred five months after her vaccinations? How do we know that the child's medical problems aren't due to complications from her mother's diabetes? Maybe drug use by the mother or father affected sperm or eggs to predispose any offspring to mitochondrial PPD or seizures or symptoms consistent with autism. The maybes could go on forever.

David Kirby writes:

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.

Is he seriously suggesting that the child in this case is analogous to a kid killed by a peanut? If so, we should note that we would not hold anyone liable if a kid ate a peanut and died, unless the one who gave him the peanut had knowledge that the child had a metabolic condition that would lead to death if he ate a peanut. If the peanut company knew that some people have such a condition and might die from their product, they have an obligation to put a notice on their product, but they do not have an obligation to identify such people or to actively prevent such people from eating their product. If the identification of the peanut or the vaccine as the cause of death or illness is determined only after the death or illness occurs, how could we hold anyone responsible for either? In any case, it is pure speculation that the vaccines either affected the child's mitochondria or stimulated her array of medical problems.

I have no idea what the legal implications of this case will be, but I don't think it will have any impact on those doing scientific research on autism or on the relationship of vaccines to any particular disorder.

update: February 29, 2008: Presidential candidate John McCain showed his ignorance by claiming that there is "divided scientific opinion" on the matter of vaccines causing autism and "there’s strong evidence that indicates that it’s got to do with a preservative in vaccines."

further reading

--Here’s How the Anti-Vaxxers’ Strongest Argument Falls Apart
The “vaccine injury court” is more properly known as the Office of Special Masters, which itself is a division of the United States Court of Special Claims. 

--More Questions for David Kirby

--Ten Myths about Autism - Debunked

--"Vaccines & Autism - Myths and Misconceptions - The Anti-Vaccination Movement" by Steven Novella

--Orac's blog on the issue (Respectful Insolence) 2008/02/28

--Deal in an Autism Case Fuels Debate on Vaccine by Gardiner Harris, New York Times, March 8, 2008 Harris erroneously states that the child, Hannah Poling, was diagnosed with autism in 2001.

--SocraticGadfly: Vaccine- chasing law firm in an intimidating huff

She was diagnosed with "regressive encephalopathy with features consistent with an autistic spectrum disorder, following normal development." As noted above, Dr. Zimmerman, who made this diagnosis, had not seen Hannah before and so his claim that the features she manifested followed "normal development" had to be made on the basis of somebody else's judgment. Only her parents would have spent enough time with the child to make this claim and their opinion is obviously tainted and biased, though one might sympathize with them and understand their bias. Hannah's other doctors could only justifiably say that she appeared to be developing normally. As Harris points out in his article, children with mitochondrial disease will often develop normally for awhile. He cites Dr. Edwin Trevathan, director of the National Center for Birth Defects and Development Disabilities at the disease control agency: children with mitochondrial disorders often develop normally until they come down with an infection. Then their mitochondria are unable to manufacture the energy needed to nourish the brain. There is no scientific basis for claiming that mitochondrial disorders are caused by vaccines, though that is what Hannah's mother believes to be the case.

Probably the most important point made by Harris is that the government does not see this case as admitting vaccines cause autism.

“Let me be very clear that the government has made absolutely no statement indicating that vaccines are a cause of autism,” Dr. Julie L. Gerberding, director of the Centers for Disease Control and Prevention, said Thursday. “That is a complete mischaracterization of the findings of the case and a complete mischaracterization of any of the science that we have at our disposal today.”

The disclaimer seems to be falling on deaf ears among the anti-vaccination crowd. Expect to see more parents not getting their children vaccinated because of the misguided belief that, as Jenny McCarthy put it, vaccination is the autism drug.

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*The panel may have made their decision based on pity. Here is a description (from MSNBC, erroneously claiming that she has autism) of the scene when the mother argued her case before the Special Master:

Wearing noise-canceling headphones, [the child] was brought into the courtroom in a wheelchair at the start of the proceedings. She stayed only a short time, moaning audibly several times. Besides autism, [she] suffers from inflammatory bowel disease, glaucoma and epilepsy. In addition, her bones, weakened by years of malnourishment, are prone to breaks, [her mother] said. Everything she eats is pumped in through a feeding tube, except for crackers and water.*