Pace Vaccine Court Study

MEDSCAPE

Anti-Vaccine Proponents Claim Court Paid for Autism Cases

Experts Say Erroneous Conclusion Due to False Definition of Autism

Robert Lowes

May 10, 2011 — A new law journal article challenges the assertion by the federal government that although it has compensated families for vaccine-induced injuries, it has “never concluded in any case that autism was caused by vaccination.”

According to the article, published online today in Pace Environment Law Review (PELR), roughly 3% of vaccine injuries compensated by the Department of Health and Human Services (HHS) involve acknowledged brain damage that included autism. This rate of association is roughly triple that of the prevalence of autism among children, the authors write. Although this assessment does not purport to be science, they state, it does justify a congressional investigation along with medical studies into an association between autism and vaccine-injury awards that federal officials may have known but failed to disclose.

“Congress needs to find out whether there was a cover-up,” lead author and attorney Mary Holland told Medscape Medical News. “It doesn’t look good.” Holland is managing director of the Elizabeth Birt Center for Autism Law and Advocacy, a research scholar at New York University School of Law, and coeditor of the 2011 book Vaccine Epidemic: How Corporate Greed, Biased Science, and Coercive Government Threaten Our Human Rights, Our Health, and Our Children.

Paul Offit, MD, an infectious disease expert, counters that the study’s conclusions and recommendations fly in the face of published research that fails to find a causal relationship between childhood vaccinations and autism.

“How much money has to be spent on this fruitless dead end?” said Dr. Offit, author of the book Deadly Choices: How the Anti-Vaccine Movement Threatens Us All and coinventor of the rotavirus vaccine. “I think it’s an enormous disservice to people with autism and their parents to beat the drum like this.”

Study Questions Distinction Made Between Brain Damage, Autism

The PELR study centers on the Vaccine Injury Compensation Program (VICP), operated by an HHS agency called the Health Resources and Services Administration (HRSA). Created by Congress in 1986, the VICP bypasses the regular civil court system to settle vaccine-injury claims through the US Court of Federal Claims — hence the popular references to a federal “vaccine court.”

The study authors looked at roughly 2500 claims of vaccine injury as of October 2010 that were compensated by the VICP since the program’s inception. Eighty-three were cases of acknowledged encephalopathy and seizure disorder that included autism or autism-like symptoms. Most involved the combination vaccine for diphtheria, pertussis, and tetanus. The second most common was the combination vaccine for measles, mumps, and rubella (MMR). Awards ranged from $80,000 to $5.9 million.

In 21 of these 83 cases, the federal claims court stated the petitioners had autism or described the condition unambiguously, according to the study. In the remaining 62 cases, the authors determined through structured interviews with parents that the children had autism or an autism spectrum disorder (ASD). All in all, there was confirmation of autism or an ASD beyond parental report in almost half of the 83 cases, according to the study.

“The evidence of an association in these cases between recognized vaccine injuries (encephalopathy and residual seizure disorder) and autism exists,” write Mary Holland and her coauthors. “Based on this preliminary assessment, there may be no meaningful distinction between cases of encephalopathy and residual seizure disorder that the VICP compensated over the last 20 years and the cases of ‘autism’ that the VICP has denied.”

Dr. Offit said the study authors reach erroneous conclusions due to an erroneous definition of autism. A child with measles encephalopathy, he said, may have severe cognitive deficits that fall into the autism spectrum, but such symptoms themselves do not necessarily translate into a diagnosis of autism. A spokesperson for HRSA mounted the same defense — shared symptoms do not make 2 different conditions identical — in an email to Medscape Medical News. The spokesperson affirmed that while the US Court of Federal Claims has granted awards for encephalopathy, it has never granted awards for autism per se.

The HRSA spokesperson also said that the federal claims court, in a mass adjudication of autism cases, found no credible evidence that MMR vaccine, vaccines containing thimerosal, or a combination of these can cause autism.

“This issue has had its day in court,” added Dr. Offit, a professor of vaccinology and pediatrics at the University of Pennsylvania School of Medicine. “This hypothesis has been tested thoroughly. The question has been asked and answered.”

Article References Book Chapter by Andrew Wakefield

The PELR study follows on the heels of 2 other studies on the subject of autism released this week. A new article in the May issue of the Archives of General Psychiatry reports that the prevalence of ASD in adults is the same as that in children — approximately 10 per 1000 individuals — and higher than some earlier studies have suggested. And a new study published online May 9 in the American Journal of Psychiatry and funded by the advocacy group Autism Speaks found that as many as 1 in 38 children in South Korea may have autism.

Earlier this year, the BMJ published a series of articles and editorials stating that an influential 1998 article in The Lancet by Andrew Wakefield — which purported to show a causal link between the MMR vaccine and autism — was an outright fraud. The Lancet had retracted the piece last year.

The name of the British researcher — who was stripped of his medical license — shows up in a footnote in the PELR article. Readers are referred to a chapter in Holland’s 2011 book that Wakefield coauthored on scientific studies that “support a possible link between vaccines and autism.”

Asked about the reference to Wakefield possibly tainting the PELR article, Holland replied, “The story on Andrew Wakefield is far from over.”

In a chapter that she herself wrote in her 2011 book, Holland chronicled the Wakefield affair and concluded that he was unfairly punished “for his temerity to caution the public about vaccine risks and to urge them to use their own judgment.” Wakefield, she wrote, has joined an honorable tradition of dissidents like Galileo and Nelson Mandela, and the world will eventually recognize that he stood up “for the practice of medicine and the pursuit of science.”

Dr. Offit agreed that both Wakefield and Galileo were both rebels who went against the grain.

“The critical difference,” he said, “was that Galileo was right.”

Pace Environ Law Rev. 2011;28:480-544. Full text