HHS Concedes

Family to be compensated by the government in former Autism Omnibus test case.

     On November 9, 2007, a landmark court decision was made in the vaccine-autism debate. The Division of Vaccine Injury Compensation (DVIC), Department of Health and Human Services (HHS) conceded one of nine cases that had been involved in the Autism Omnibus proceedings. The concession in the case of Hannah Poling v. Sec HHS states that Poling’s vaccinations aggravated her mitochondrial disorder, resulting in “features of autism spectrum disorder.” The court also conceded that vaccines Hannah Poling received caused her epilepsy. A lawyer for the Autism Omnibus families says that the concession is a turning point.
     Hannah’s case was filed in 2002 and later became part of the Autism Omnibus cases. It was originally slated to be a thimerosal test case, but was removed from Autism Omnibus and reviewed early. The remaining thimerosal-only test cases are scheduled to be heard in May.
     Autism Omnibus is a group of over 4,900 families who believe vaccines caused autism in their children. The proceedings have been divided into three categories based on causation. The first category claims that vaccines containing thimerosal, combined with the measles, mumps and rubella (MMR) vaccine caused autism. The second points to thimerosal only as the cause, and the third category claims the MMR vaccine alone is the cause.
     “By conceding, the HHS avoided a public hearing,” says Robert Krakow, an attorney and a member of the petitioner’s steering committee. “They knew they had a vulnerability on this case.” He adds that the Polings believe that thimerosal caused their daughter’s autism, but this is not what is stated in the concession. He says the concession is worded very carefully. “They are making excuses for their failures.”
     The concession states that Poling’s mitochondrial disorder made her susceptible to her vaccine injuries. It also says that the vaccines ultimately led to “features of autism spectrum disorder.” And yet, since the concession was made, Health Resources and Services Administration (HRSA) has repeated its position that vaccines do not cause autism. Repeated attempts to speak to Department of Justice (DOJ) attorneys involved in the Autism Omnibus cases went unanswered.
     At the heart of the debate over the concession is whether Poling’s mitochondrial disorder is typical or atypical of autistic children. Jon Poling, M.D., Ph.D., Hannah’s father, says that although it is not widely published, there is indeed a link between children with mitochondrial disorders and autism. He says that preliminary studies have been conducted, estimating that seven percent of autistic children have a mitochondrial disorder. Poling says that Hannah had no evidence of a mitochondrial problem before she was 18 months old, so it is unknown whether or not she was born with it.
     The attorney of record for the Poling case, Clifford Shoemaker, had prepared two theories to present at the hearing. The first was that Hannah was born with a mitochondrial disorder, and her regression was triggered by vaccines. The second was that vaccines caused the mitochondrial disorder. Poling says he was not surprised about the concession. “We had a solid case.” He was surprised, however, that there was no hearing. “I thought they would fight it,” says Poling.
     Shoemaker was pleased by the concession and says that it provides a method of proving vaccine injury for other families. In order to award compensation, the Vaccine Program does not require absolute certainty on causation according to Shoemaker, but a “valid medical theory of causation.”
     Shoemaker adds that if other children show evidence of a mitochondrial dysfunction similar to that of Hannah Poling, the child will have the valid theory of causation.
On March 6, Poling and his wife Terry held a press conference in Atlanta, Ga. Although a gag order had been issued by the DOJ forbidding anyone to speak about details of the case, the Polings felt the need to come forward, if only to speak in generalities about the concession. “It’s been hard for Terry and me,” says Poling. “We are a part of the autism community, and we hear stories swirling on the Internet. No one knows the details about the case, and we thought the families deserved to hear from us.” Poling says that he and his wife are pleased with the concession and are hoping that it positively affects other children.
     Jim Moody, Esq., is a consultant to the Autism Omnibus. He echoes Poling’s statement about Hannah’s mitochondrial disorder, “The DOJ will say that this case is completely unique, but they do not understand the scientific background of mitochondrial disorder. This is typical of a wide range of kids, and only a tiny percentage of kids are getting a proper medical workup.”
     According to the DOJ’s statement in the case, Hannah Poling was meeting all of her developmental milestones during the first year and a half of her life. Because of ear infections, Poling did not receive her 12 and 15 month vaccines. At 18 months, she received five injections for nine vaccines. Within 48 hours, Poling developed a high fever and became irritable and lethargic.
     Over the next six months, Poling suffered from high fevers, diarrhea, decreased social interaction and speech. When she was just over 2 years old, Dr. Andrew Zimmerman, a pediatric neurologist at the Kennedy Krieger Children’s Hospital Neurology Clinic, evaluated Poling. She was diagnosed with “regressive encephalopathy with features consistent with an autistic spectrum disorder, following normal development.” When Zimmerman detected abnormal metabolic activity that suggested an underlying mitochondrial disorder, he referred Poling to Dr. Richard Kelley, a specialist in neurogenetics at the Krieger Institute. Kelley found “an etiologically unexplained metabolic disorder that appear(ed) to be a common cause of developmental regression.”
     In the concession, the DVIC concluded that the evidence sufficiently demonstrated that the vaccinations Poling received “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.” In a second concession in late February, the HHS also conceded that Hannah’s epilepsy was the result of her original vaccine injury. According to Zimmerman’s report, “epilepsy is a result of the original brain injury in Hannah. Its appearance was delayed but was part of the same pathogenesis that led to autistic encephalopathy.” Poling says that Hannah’s seizures did not manifest until April 2006, at which time they were documented in her medical records.
     No one at the DOJ or HHS would speak specifically about the Poling case, but the HRSA released a statement denying any link between vaccines and autism. Dr. Paul Offit, the Chief of the Division of Infectious Diseases and the Director of the Vaccine Education Center at the Children’s Hospital of Philadelphia, says that he would like to see the DOJ speak out about the concession. “I wish they would be forthright so that people know why they made the decision that they made,” says Offit. He says that the decision does not state that vaccines cause autism, but points instead to Poling’s mitochondrial disorder.
     Mark Geier, M.D., Ph.D., is a geneticist at the Genetic Centers of American and an epidemiologist. Geier says that he was asked by Shoemaker to evaluate the Hannah Poling case and help choose typical cases to ultimately be used as test cases. Speaking in generalities, Geier says that mitochondrial dysfunction is prevalent in several chronic diseases and can be a “pre-existing factor for autism.” Geier also adds that the government’s concession is carefully worded, “People with underlying conditions are more susceptible to vaccine damage, but if they think that this case is rare, they are wrong.” Based on tests he has conducted, Geier says that as many as a third of children with autism have a similar mitochondrial dysfunction to the one exhibited in this case.
     A doctor who has been involved in the Autism Omnibus proceedings, who provided information for the DOJ, and requested anonymity stated, “It cannot be automatically assumed that vaccines are a risk.” He states that Poling has a mitochondrial disorder that presents autism-like symptoms. “Children with mitochondrial disorder can look like they have autism, but you cannot generalize one group to another. You have to be very careful with the claims.” The doctor went on to say that as mental retardation becomes more severe, the more likely there are to be symptoms of autism, “but there is a difference between mental retardation and autism.” He stresses that Poling’s case was not a matter of whether or not she has autism, it was a matter of her mitochondrial disorder. He explained that someone who suffers from mitochondrial disorder has reduced cellular energy. The doctor described the disorder as a “battery running on half a charge,” and states that Poling’s vaccines aggravated this disorder and features of autism resulted.
     Offit added that this is a unique case. “This is not a case of autism. This is about the severe mitochondrial disorder of the child,” he says. “This is a rare case that creates a false notion that vaccines cause autism. This case should not become a precedent. The notion that other kids will be found who have the same mitochondrial disorder is impossible. It won’t happen.”
     Poling believes that Offit’s statement is incorrect. He says that Kelly, a neurologist who specializes in metabolic disorders and who evaluated Hannah, said that his daughter’s condition is indeed common. “But,” says Poling, “there is no research money allocated to this issue. I think we can prevent insults to kids like Hannah.” Poling says that the current genetic research is not getting any closer to helping children in Hannah’s situation. “First, we have to figure out how common mitochondrial disorders are, and then find out if there is a way to detect them. If we can figure out how to screen for what Hannah has, we can prevent this from happening.”
     Making the distinction between mitochondrial disease, which is a rare, genetic disease, and mitochondrial dysfunction, from which Poling suffers, Shoemaker also disagrees with Offit’s statement. “Mitochondria can be affected by environmental triggers,” says Shoemaker. “Thimerosal is one of them. Some kids are more susceptible to damage. There is a certain amount that they cannot deal with, and they are unable to excrete it.” He says that in susceptible children, such as Poling, the result can be damaged mitochondria.
     Speaking about the link between vaccines and autism, Offit says that this is a question that been asked and answered. “This is no longer a scientific or medical controversy. There’s not one shred of evidence that thimerosal causes autism.” Offit questions why there is an ever-increasing number of autism diagnoses, “years after thimerosal has been removed from the vaccines.” The doctor also takes issue with the continuous media attention on the vaccine issue. He says that it is natural for parents to question thimerosal in vaccines, but says that public health officials have answered these questions.      “Epidemiological studies have been done, and there is no evidence that vaccines cause autism. It’s just not true, unless you choose to believe that public health officials are in conspiracy and want to hurt the public,” says Offit.
     In an interview on his morning radio show in March, Don Imus asked Evidence of Harm author, David Kirby about thimerosal in vaccines. Kirby said that thimerosal is, in fact, still present in vaccines. He says that there is “residual mercury” in many shots, and there is also “the full amount of mercury” in flu shots currently given to children and pregnant women. He says that these shots can amount to 85 milligrams of mercury per child. Although this number is less than it was a few years ago, this reduced amount of mercury is still enough to negatively affect a child with a mitochondrial disorder or some kind of autoimmune weakness or allergy.
     Geier also points to the flu shot as a continual and unacceptable source of mercury. In his opinion, the concession in the Poling case is one of the most important court decisions in United States history. “It puts the HHS in a position, and I don’t know how they can get out of it.” Geier says. The doctor also says, that the government’s position on vaccines has always been the same and they do not cause any damage whatsoever. “Now,” says Geier, “they’re own scientists have conceded that vaccines contribute to autism-like symptoms. I personally call it mercury poisoning.” He says that in light of this concession, the government simply cannot continue to state that vaccines do not cause autism.
     Shoemaker is also angered by the continued use of thimerosal. “They are still subjecting kids and pregnant women to the flu shots with thimerosal. This is criminal and it needs to stop.” He also feels that Congress needs to remove the statute of limitations on vaccine injury. “There are about 5,000 Autism Omnibus cases, and there should be about 50,000 cases,” says Shoemaker. Since the concession in the Poling case has been made public, Shoemaker says his offices have received hundreds of calls from people whose children have suffered from the same problems as Poling. Sadly he admits that it is too late for many of these families to seek compensation.
     Geier says that many families he works with would be satisfied by knowing what caused autism in their children. “They are not anti-vaccine. They are not money-hungry. They just want an answer.”
     “The government just can’t say that vaccines do not cause autism,” Moody adds. “It would be more accurate to say that ‘vaccines cause autism in some cases.’” He also says that the government should be advising parents to have their children tested for mitochondrial disorders.
     Michelle Cedillo’s case was the first Autism Omnibus case to be filed in June 2007. The family’s lawyers and the DOJ completed filing responses earlier this year, and a decision is still pending. Cedillo was diagnosed with autism at the age of three. She suffers from refractory seizures, an ulcer, inflammatory bowel disorder, arthritis and autism spectrum disorder. Her parents, Theresa and Michael, are hoping to hear a decision in her case some time this year.
     Offit says the concession has caused a “false notion that vaccines cause autism.” Families such as the Polings and the Cedillos do not believe that this is a “false notion.” Their determination has gotten them to Washington, D.C. Encouraged by this concession, the Cedillos and others will hope for compensation for the lifetime of care ahead of them. One glaring fact that the HHS and DOJ cannot question comes at the beginning of the post-hearing brief from Cedillo’s case. “Michelle and thousands of other autistic children, who are residents of all 50 states, have filed petitions in the program. They are not going away. They are desperate.”