Autism claims on thimerosal reach special "vaccine court"

Although the scientific evidence would seem to absolve vaccines from blame in causing autism, many parents remain unconvinced.

By Susan J. Landers — Posted July 9, 2007

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The debate over mercury's role in causing autism is having its day in court. A test case is under way in the U.S. Court of Federal Claims in Washington, D.C., to determine if the autism diagnosed in a 12-year-old girl was caused by a measles, mumps and rubella vaccine administered when she was an infant.

Cedillo v. Secretary of Health and Human Services is the first to be heard of the 4,800 petitions filed by families of children with autism. Its outcome is of prime importance to the families seeking monetary support to help care for their children. It is also of great importance to physicians who are concerned that a decision favoring the families could undermine the perceived safety of vaccines.

A preponderance of scientific evidence gathered by Centers for Disease Control and Prevention studies and Institute of Medicine reports has cleared vaccines and the mercury-containing preservative thimerosal of any autism involvement. But many parents and others are unconvinced.

In 2001, thimerosal was removed from most vaccines routinely given to infants.

The case now being heard by a special master appointed under the congressionally mandated National Vaccine Injury Compensation Program began June 11 and was expected to conclude in about three weeks. Two other special masters, who serve as judges, each would hear other test cases before any decisions are rendered.

Decisions made in these special "vaccine courts" also can be appealed in civil courts.

A time frame for a decision is uncertain. The first test case, which is serving as a representative for some of the thousands of pending petitions, was to have been concluded by June 29. A second case has been selected to begin after that. But a third case had yet to be chosen.

"I think this will play out in one of two ways," said Paul Offit, MD, director of the Vaccine Education Center at the Philadelphia Children's Hospital. "The most likely way is that the three special masters will agree with the scientific evidence and find there is nothing to this and they will therefore not compensate the 4,800 plaintiffs."

Dr. Offit also speculated that the plaintiffs may be so discouraged that they won't bring cases to civil court.

Opening doors

On the other hand, if the court decides in favor of the family, "a door gets opened," he said. And that is worrisome to those who believe that vaccines represent a public health triumph. They fear that such a decision could mean increased litigation that would cause vaccine companies to halt production and could raise more questions in parents' minds about vaccine risks.

The scientific evidence that supports vaccine safety is epidemiological and carries only a certain amount of statistical power, Dr. Offit said. "For instance, it is very hard to prove that something isn't occurring in one in a million children."

Families of children with autism also are paying close attention. The case is being heard in the largest available courtroom in the city -- one that seats 400 to 450 people -- and phone lines have been set up to allow callers to follow the hearing live.

The case signals "a historic time" for these families, said Wendy Fournier, president of the National Autism Assn., an advocacy group based in Missouri. She discounts findings of the IOM reports and CDC studies, saying they are of little worth, since their research is based on epidemiologic findings. "So you are looking at just playing the numbers game. They are very easy to manipulate."

Louis Cooper, MD, a member of the steering committee of the vaccine advocacy group, the National Network for Immunization Information, to which the American Medical Association belongs, said a decision in the case will be "profoundly important." He expects a decision that will absolve vaccines of blame. "I have, like most of us, a lot of faith in the absence of bias within the special masters who function in the vaccine court."

Dr. Cooper hopes that the conclusion of court proceedings also will signal the end of the long-running debate over the role vaccines might play in triggering autism. The discourse, under way for about a decade, has caused the diversion of many resources from other promising research, he noted.

Peter Hotez, MD, PhD, the father of a 14-year-old daughter with autism and the president of the Sabin Vaccine Institute in Washington, D.C., which develops vaccines for tropical diseases, said he also would like to put the vaccine theory to rest.

During a recent briefing on the hearing sponsored by Every Child by Two -- a Washington, D.C.-based group that promotes early vaccination -- Dr. Hotez said he is confident that his daughter's autism was not caused by the vaccines she received.

He also took issue with what has been widely perceived as an epidemic. The most recent CDC data indicate that as many as one in 150 8-year-olds in multiple areas of the U.S. were diagnosed as having autism spectrum disorder, which represents a range of developmental disorders from the more serious autism to the less serious Asperger syndrome.

For decades, the best estimate for the prevalence of autism had been four to five per 10,000 children. The question that arose was whether this apparent increase was attributable to more children actually having the disorder or better diagnosis and estimates. Dr. Hotez favors the latter answer.

He also said organic mercury toxicity causes a syndrome that bears no resemblance to autism. New research points to missing or abnormal genes as a cause and is worthy of additional pursuit.

The alleged link between autism and vaccines has become a "terrible distraction," he said. "To me it's like espousing that the world is flat."

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Program handles vaccine claims

A hearing in Washington, D.C., to determine if a thimerosal-containing measles, mumps and rubella vaccine caused autism is drawing attention to a little-known federal program designed as a no-fault system to compensate fairly those injured by required vaccines and to keep manufacturers in the vaccine business by protecting them from high litigation costs.

Congress established the National Vaccine Injury Compensation Program in 1988 to provide a fair, rapid and less costly alternative to the courts for individuals claiming vaccine-related injuries. The program is funded by a tax levied on every dose of childhood vaccine.

The awards granted are controlled through a Vaccine Injury Table that lists the vaccines and the adverse events associated with them as well as the time period in which those injuries should become apparent.

For example, compensation is provided when a rubella virus-containing vaccine results in chronic arthritis in seven to 42 days after the vaccine is given or a tetanus toxoid-containing vaccine results in anaphylactic shock within four hours.

But if an injury is not on this list, an individual still can come into the program and prove that the vaccine caused the injury. This process has now begun for autism with Cedillo v. Secretary of Health and Human Services in the U.S. Court of Federal Claims in Washington.

Amounts that can be granted have been set at $250,000 for a death, and they average about $824,000 for injuries. The program has paid out more than $900 million in compensation. It also lets people reject a decision and file a lawsuit in civil court.

Cases are generally heard one at a time, but since nearly 4,800 autism cases are pending, they have been gathered in an Omnibus Autism Proceeding. The intention is to hear three representative test cases.

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