First autism-vaccine test case goes to court under Vaccine Injury Compensation Program

August 2007

WASHINGTON — At press time, the United States Court of Federal Claims was hearing testimony from a family who believes there may be a link between their daughter’s autism and the measles-mumps-rubella vaccine and thimerosal.

About 4,800 similar cases are pending in the Vaccine Injury Compensation Program. Three special masters will preside over nine “tests cases” to decide whether the claims are valid, and the proceedings have been dubbed the Omnibus Autism Proceedings. The petitioners in this first test case are Michael and Theresa Cedillo, whose 12-year-old daughter Michelle has autism as well as other medical conditions, such as gastrointestinal problems.

The special masters will hear three cases with respect to each of three separate theories of the root cause of autism. The Cedillo case involves the theory that the combination of the MMR vaccine and vaccines that contain thimerosal causes autism-spectrum disorder. The other two theories put forth the idea that just thimerosal-containing vaccines are associated with autism and that just the MMR vaccine is associated with autism. Only two of the three test cases for the combination theory had been selected at press time.

“Given the tremendous number of cases that were filed involving this issue, the special masters have treated these cases differently. Generally in the VICP, cases were managed individually, case-by-case,” said Emily Marcus Levine, attorney with the Office of the General Counsel, Department of Health and Human Services, who spoke about the hearings at the National Vaccine Advisory Committee Meeting, held in Washington.

Background

In 2002 a chief special master created the Omnibus Autism Proceeding, according to Randy Moss, partner at WilmerHale in Washington and co-chair of the firm’s government and public policy litigation group. He spoke on the issue at a press briefing held by Every Child by Two and the Sabin Institute.

The autism-MMR vaccine scare began in 1998, when the Lancet published data from Andrew Wakefield, MD, and 12 colleagues that purported to find an association between MMR vaccine and autism. MMR vaccination declined, particularly in the United Kingdom, following publication of these data.

Ten of the 12 researchers later retracted the article’s findings after it was reported there were pivotal discrepancies between the published data and the confidential medical records of Wakefield’s patients.

Petitioners’ testimony

Arthur Krigsman, MD, pediatric gastroenterologist who worked at Lenox Hill Hospital from 2000 to 2004, was one of the expert witnesses that testified on behalf of the petitioners. Krigsman testified that he suspected Michelle had a disregulated immune system at the time of vaccination and that she has persistent measles virus in the lymphoid tissue of her bowel.

H. Vasken Aposhian, PhD, a toxicologist who also testified on behalf of the petitioners, told the special masters that a subset of the general population has a hypersensitivity to mercury injury.

During cross-examination of Edwin H. Cook Jr., MD, who was one of the witnesses that testified for the respondent, Sylvia Chin-Caplan, Esq., of Conway, Homer and Chin Caplan, P.C. in Boston, asked Cook about the study Aposhian spoke about on the hypersensitivity to mercury injury.

“I looked at that paper, and nowhere did it say that the changes that it was seeing were damage as you’re using in your question. And also in the paper, it frankly was not a positive association,” said Cook, who is a psychiatrist at the University of Illinois at Chicago.

Respondent testimony

Cook focused on the genetic association during his testimony. He said that the risk of autism in a child born to parents who already have one autistic child is increased 5%, which is a 25-fold increase compared with the risk of autism in the general population.

Identical twin studies are important, according to Cook. Researchers who performed identical twin studies found that if one identical twin has autism, the other twin faces a 60% chance of being autistic as well, which is a 300-fold increase compared with the general population, he said. In addition, Cook said that it is not plausible that a vaccine or a component of a vaccine can trigger something in genetically predisposed individuals to cause them to develop autism.

Chin-Caplan said that these children received their autism diagnosis very close to the time they received their MMR vaccine and asked Cook whether the vaccine could cause autism.

“Now the reason that I’m not going to acknowledge what you’re asking – in other words, is there a relation between the MMR vaccine and what happened later – is because it is the same logic used to blame mothers for causing autism, because there is a mother, they take care of their child, and they develop autism. It is exactly the same logic,” Cook said.

Eric Fombonne, MD, professor of psychiatry, McGill University, Montreal, testified that he has seen the public health effects of the lack of vaccination. Fombonne was in the United Kingdom when the Wakefield hypothesis surfaced and witnessed the very low MMR vaccine coverage rates that followed.

“I saw epidemics of measles in Ireland, for instance. The MMR coverage dropped to very low levels and three children died in 2000,” Fombonne said.

He also discussed the association between genetics and autism. According to Fombonne, Fragile X is a disorder on the X chromosome; it is methylated. This is the most common cause of mental retardation, he said.

In addition, 30% to 40% of children who have Fragile X also meet the criteria for autism, Fombonne said.

No association found

Paul A. Offit, MD, chief of infectious diseases at the Children’s Hospital of Philadelphia (CHOP), expects that the special masters will not grant the petition. Offit added that none of the 14 epidemiological studies that have been conducted analyzing any potential association between MMR vaccine and autism found any associations nor did any of the five epidemiological studies analyzing any potential association between thimerosal and autism.

“The court is not a place to settle scientific questions. The court is a place to settle dispute. There is no dispute,” Offit told Infectious Disease News.

Offit said that the tide seems to be turning against the fears of the perceived association between vaccines and autism. The mainstream media are focusing less on the scientifically unproven theories, and organizations like the CDC, AAP and CHOP’s Vaccine Education Center have been “gearing up” to stress the importance of vaccinations, according to Offit.

“I think things are getting better. I’m very optimistic. I’m a Philadelphia Eagles fan, so I like to believe we’re going to win,” Offit said.

He mentioned the fear in the 1970s over the association between pertussis vaccine and brain damage in infants. The link was unfounded, but vaccination rates decreased, while pertussis deaths increased.

“I just hope we learn from this,” Offit said.

At the end of the proceedings, either party may appeal to a judge on the U.S. Court of Federal Claims, Levine said.

For more information:

• Marcus Levine E. Omnibus autism proceeding in the U.S. Court of Federal Claims. Presented at: The National Vaccine Advisory Committee Meeting; June 7-8, 2007; Washington.
• For copies of the proceedings’ transcripts or to listen to the proceedings, visit the Court of Federal Claims’ website at: www.uscfc.uscourts.gov/OSM/OSMAutism.htm.