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High-stakes trial weighs autism claims
One family's anguish is front and center in a long-awaited legal fight over whether there's a link between disorder and vaccines.
By Jia-Rui Chong and Thomas H. Maugh II, Times Staff Writers
June 25, 2007
WASHINGTON - Theresa and Michael Cedillo, the parents of an autistic child, sat behind their three attorneys on one side of the courtroom.
On the other side were three federal lawyers armed with a shelf full of scientific studies and legal briefs. Behind them were more rows of lawyers and scientists, some of them representing the biggest pharmaceutical companies in the world.
It was a lopsided gathering, but the Cedillos had been waiting for the confrontation since they came to believe years ago that their daughter's autism may have been triggered by a combination of childhood vaccines and a mercury preservative used in them.
"For so long no one wanted to hear," said Theresa, 45. "Now someone wants to listen."
The case of Cedillo vs. Secretary of Health and Human Services is the culmination of one of the most wrenching episodes of modern public health.
For more than a decade, thousands of families of autistic children have clamored to gain legitimacy for their claim that childhood vaccines are to blame for their children's plight.
Now they are having their day in court. "We're hoping we can … open the gates for other children who are ill," said Michael Cedillo, 51, a meter reader and bill collector for an electric company in Arizona.
Arguments in the Cedillos' case began June 11. Theirs is the first of nine families that will appear over the next year in an obscure federal court that rules on injuries possibly caused by vaccines. The cases were chosen to represent 4,800 autism claims that have flooded the vaccine court in recent years.
The stakes are high. The court oversees a $2.5-billion trust fund that could be drained if the parents win their claim.
Public health officials have warned that a finding favorable to the parents could deter other parents from vaccinating their children, a potential health calamity.
The government position is backed by the overwhelming weight of scientific evidence, which has repeatedly found the vaccines safe.
But what the Cedillos and other parents lack in hard data, they have made up for with a stubborn passion and sorrow that science cannot dispute.
"It is parents versus science," said Kevin Conway, one of the attorneys for the Cedillos.
Preservative blamed
At the center of the case is Michelle Cedillo. At 12, she still sleeps in diapers. She mostly communicates by waving her hands or tapping on a table. She can count to 2 but no higher.
Her parents say Michelle was a happy, normal 15-month-old until she received the measles, mumps and rubella vaccine, commonly known as MMR, on Dec. 20, 1995.
A week later, she began to have a fever that soared to 105.8 degrees. "She was a whole different child" after the fever broke, her mother said.
Michelle pushed her father away when he tried to nuzzle her. She stopped talking and didn't answer to her name. She became obsessed with watching the same "Sesame Street" videos.
Michelle was soon diagnosed with autism. "We were totally numb," said her mother.
The disorder leaves its victims isolated from the world around them. Autistic children typically are unable to understand others' emotions, have difficulty speaking and are prone to repetitive actions.
Some autistics are able to function almost normally; others are severely impaired.
There are no nationwide data documenting the historical incidence of autism. Twenty years ago, psychiatrists estimated the rate at 1 in every 2,000 to 5,000 children. Last year, the Centers for Disease Control and Prevention found that 1 in 150 schoolchildren had been diagnosed with it.
Some parents think autism can be caused by a vaccine preservative called thimerosal, which contains ethyl mercury. Partly on the precautionary urging of the U.S. Public Health Service, the use of thimerosal was abandoned in 2001 in childhood vaccines, except for influenza vaccines.
Mercury can cause neurological problems, and some studies have concluded there is a link with autism.
Parents groups frequently cite a 2006 study by French and British researchers that found indications of elevated mercury and other heavy-metal levels in children with developmental and neurological disorders, including autism.
But at least 14 separate mainstream studies have rejected the connection, showing that the rate of autism is the same in children who received thimerosal and those who did not.
The growth of the disorder also has not abated since thimerosal was removed from vaccines.
The results are "clear and consistent and reproducible," said Dr. Paul Offit of the Philadelphia Children's Hospital.
Many researchers believe that genetics is behind autism. Dr. Peter Hotez, president of the Sabin Vaccine Institute in Washington, noted that when one identical twin has the disorder or other serious social impairment, there is a 90% chance that the second twin will as well.
But, parents ask, how can an epidemic be caused by genes?
Some researchers argue that there is no autism epidemic.
An analysis of data from 44 states, led by researchers at Washington University and the University of Wisconsin, found that the increase in autism was completely offset by a decrease in the prevalence of children considered cognitively or learning disabled. In other words, they say, children simply have been shuffled from one category to another.
The Cedillos have read reams of studies. Theresa, a stay-at-home mother, spends most of her time caring for Michelle or scouring the Internet.
She doesn't doubt the science, but she questions whether it has searched deep enough to find the key that explains Michelle.
"I know what they've said, but I believe it happened the way it happened," she said.
In the courtroom
Amid a sea of business suits, Michelle sat struggling in her wheelchair in a white dolphin T-shirt on the first day of the trial.
Even though she wore noise-canceling headphones to screen out the courtroom hubbub, she was overwhelmed by the new surroundings. She jerked in her wheelchair, groaned and hit herself in the face until her parents took her out.
The Cedillos mortgaged their home in Yuma, Ariz., to stay in Washington for the three weeks of the trial.
Special Master George L. Hastings Jr., who is presiding over the case with two others, thanked the family for being at the trial.
Even in the labyrinthine bureaucracy of Washington, vaccine court is an obscure venue.
In the past, civil courts would have handled cases like Michelle's. That situation changed in the 1980s when the vaccine industry faced a rash of lawsuits over brain damage caused by the childhood diphtheria-pertussis-tetanus vaccine.
After the price of the vaccine rose 2,000% over a two-year period and at least one manufacturer abandoned the business, Congress established the National Vaccine Injury Compensation Program in 1988.
Through congressional funding and a 75-cent surcharge on each vaccine dose, it created a fund that now totals $2.5 billion.
Given the millions of people who receive vaccinations each year, the number of claims is tiny. Since 1990, the court has granted awards totaling $725.7 million in 857 nonautism cases.
The nine autism test cases are divided into three groups - one blaming autism on the MMR vaccine, one blaming mercury and one blaming both.
In many ways, Michelle seems a strange choice for the first test case, because she is not a typical autistic child. She has also been diagnosed with inflammatory bowel disease, arthritis, osteopenia, uveitis and epilepsy.
But her case, which is based on the combination MMR-mercury claim, was deemed one of the strongest. Medical tests have found measles virus in her body that matched the strain in the MMR vaccine.
Dr. Marcel Kinsbourne, a pediatric neurologist from the New School University in New York, cited previous studies in testifying that it was plausible Michelle's immune system had been damaged by thimerosal in the nine childhood vaccines she had received. The measles virus in her body could then have spread to her brain and triggered autism, Kinsbourne testified.
The government's case is no surprise. It arrays scientific studies like chess pieces across a playing board.
"Good science does apply," said lead attorney Vince Matanoski in opening arguments. "What has no place here or in any federal court is junk science."
The Cedillos have their scientists arrayed as well. They also have Michelle.
In the early days of the trial, the Cedillos' attorney showed videos of Michelle before she received the MMR vaccine.
To the Cedillos, it was so clear. Michelle squealed with laughter, called out to her mother, played peekaboo and spoke the name of Bert from "Sesame Street."
The government showed scenes from the same videos.
Dr. Eric Fombonne, a child psychiatrist from McGill University in Canada, pointed out Michelle's lack of speaking, her fixation on objects, and an absence of joy on her face when her mother spoke to her - before Michelle received the MMR vaccine.
"She is very abnormal," Fombonne said.
The Cedillos were prepared for this. They knew it would be hard for others to see Michelle as they saw her.
"There was more to her life than what was shown in the videotapes," Theresa said.
The Cedillos sat quietly through the testimony. It was a long day, and when it was over, they headed back to their hotel to take care of Michelle.