New Vaccine Clause Angers Parents
of Autistic
Amendment Buried in Homeland Security Law
Restricts Right to Sue Makers of Drug Preservative
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Tom and
Donna Brinker, of Glen Mills, Pa., with their son, Thomas, 8. The
boy is a plaintiff in a class-action suit alleging makers of the
preservative Thimerosal caused him to develop autism.
(Photos Barbara Johnston For The Washingon
Post)
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By Susan Warner
Special to the Washington Post
Monday, December 9, 2002; Page A03
Thomas Brinker loves to sing and play with string. He watches ABC News
anchor Peter Jennings on television every night and shouts: "Tickle Peter
Jennings." He's 8 now, but his attention span is short and his temper flares
easily.
Thomas has autism, a condition his parents believe was caused by a simple
childhood immunization. "We're waiting for his first normal moment," said
his mother, Donna Brinker of Glen Mills, Pa.
It was Donna Brinker's temper that flared when she learned that Congress
had quietly restricted her right to sue Eli Lilly and Co. and other
manufacturers of Thimerosal, the mercury-based vaccine preservative she
believes caused her son's condition. The change came in two paragraphs
tacked onto the massive Homeland Security Act just days before Congress
approved the legislation in November.
The Brinkers are among 800 families in more than a dozen states that have
filed similar cases seeking compensation for the costs of their children's
autism. Under the new law, signed by President Bush Nov. 25, the parents are
required to file claims with a special administrative court under the
National Vaccine Injury Compensation Program before they can take their
cases to civil court.
The changes could sharply reduce parents' chances of prevailing in civil
courts, where damage awards normally could be much higher than those in the
"vaccine court." The federal program covers claims for medical and education
expenses, but damages for pain, suffering and death are limited to $250,000.
Lawyers for the plaintiffs say their awards would likely be higher if they
could first take their cases to state courts, where civil juries are known
to award millions of dollars in medical injury cases.
Meanwhile, the Department of Justice has filed a request to restrict the
use of information gathered in vaccine court proceedings in subsequent civil
court cases, another potential obstacle for the plaintiffs.
"I felt betrayed," Brinker said of the new legislation. "I believe in
protecting our homeland, but it petrifies me to think that our nation would
protect any industry at the expense of our children."
Penny Starr-Ashton, of Drexel Hill, Pa., whose autistic 6-year-old
daughter, Maddie, is another plaintiff in a class-action lawsuit filed in
Pennsylvania in July, said it is particularly painful to have the provision
wrapped in the flag.
"Who doesn't want a safer country?" she asked. "But who's going to
protect me? Who's going to protect my child?"
The National Institute of Child Health and Human Development estimates
that between 1 in 500 and 1 in 1,000 children is diagnosed with autism in
the United States each year. Initial studies in the 1960s found four to five
cases of autism in every 10,000 people, although the institute cautions that
some of the increase could be due to changes in reporting and diagnosing the
disease.
A study by the University of California at Davis found that a third of
California parents of autistic children diagnosed in the mid-1990s blame
vaccines for their children's illnesses.
Congress created the National Vaccine Injury Compensation Program in 1986
to address growing concerns about vaccine safety. Claims are filed with the
Department of Health and Human Services through the U.S. Court of Federal
Claims. The program has paid out 1,775 claims totaling $1.4 billion and is
funded by a 75-cent surcharge on every child vaccination.
Brinker said parents of children with signs of mercury poisoning can
spend up to $20,000 a year out of pocket. Thomas is undergoing chelation
therapy to draw metals out of his body and is on a strict diet. His parents
take him to a specialist in Louisiana for treatment, and his mother travels
to Mexico to get drugs that are not approved in the United States.
Beyond today's expenses, Brinker worries about supporting Thomas in the
long term. "The mercury preservative has deprived Thomas of having a normal
life," she said. "That our nation would protect such a killer is beyond
comprehension."
Aside from potentially lower awards, Thomas Brinker and Maddie Ashton
will have another problem in vaccine court, said their lawyer, Tobi Millrood.
Like many children, they were diagnosed with autism more than three years
after their vaccinations, beyond the time permitted to file under the
program's rules.
Some states, including Oregon, Florida, Louisiana, Illinois and
California, had ruled that they had jurisdiction over Thimerosal cases, said
John Kim, a Houston lawyer who argued against the government's request to
close vaccine court records. "Now I guess this new provision in the Homeland
Security Act trumps that," Kim said.
Meanwhile, all Thimerosal cases have been put on hold at vaccine court
while the court grapples with the scientific debate over the possible causes
of autism. The Office of the Special Master, which oversees procedural
issues at vaccine court, expects 3,000 to 5,000 filings.
Parents outraged about the last-minute change point to Eli Lilly, the
Indianapolis drug maker, as its biggest beneficiary. Lilly invented
Thimerosal and manufactured it until the 1980s. The preservative is 50
percent mercury by weight, and had been used in vaccines since the 1930s.
Lilly is a defendant in 200 Thimerosal-related lawsuits.
"It's turned into being about money," Brinker said. "Parents with kids
with autism don't have the money to give to congressmen. It turns out
whoever has the most money wins."
The provision in the Homeland Security bill was originally written by
Sen. Bill Frist (R-Tenn.), a physician, as part of broader legislation aimed
at helping drug companies produce vaccines after post-Sept. 11, 2001,
concerns about smallpox and anthrax. The number of U.S. vaccine
manufacturers has dropped to four, with companies complaining of low profit
margins, manufacturing problems and fear of liability for injury.
Edward G. Sagebiel, a spokesman for Lilly, said his company had no role
in pushing the last-minute legislative changes. "We express sympathy for the
parents and the children who have suffered adverse reactions," he said.
"However, the lawsuits that have been filed against Lilly and other
manufacturers are not supported by science."
The House Government Reform Committee has scheduled a hearing on vaccine
safety for Tuesday.
In 1999, the Food and Drug Administration conducted a review of
Thimerosal and found no evidence of harm beyond limited cases of
hypersensitivity to the vaccine. But the same year, the Academy of
Pediatrics and the U.S. Public Health Service recommended that Thimerosal be
removed from vaccines, partly out of fear that parents would stop immunizing
their children and create a bigger public health problem.
In October 2001, the Institute of Medicine, a branch of the National
Academy of Sciences, said there was no evidence that Thimerosal caused
autism, but it did say the theory was "biologically plausible."
Most recently, on Nov. 30, the British medical journal the Lancet
published a study showing that infants who received vaccines containing
Thimerosal had levels of mercury in their blood that are within federal
limits.
Starr-Ashton remains unconvinced. "I don't believe anything that is 50
percent mercury by weight is safe," she said. She noted reports of health
damage caused by mercury in fish, thermometers and dental fillings. "I'm not
that dumb."
The debate over science has become a furor over the democratic process in
the tight-knit community of parents of children with autism that is linked
by the Internet and community support groups.
"Nobody is owning up to it," Brinker said. "It is so underhanded. I just
can't believe our government would do this. We're not going to back down on
this issue. We will not be silent."
Starr-Ashton said she is not against vaccines, especially because she
taught in a school for the deaf for many years: "I saw first-hand the damage
done by rubella."
But now she does not know who to trust. "Here I was, a dutiful parent
taking my child to do what the government and the Academy of Pediatrics said
I should do to protect my child against disease," Starr-Ashton said.
"Something went terribly wrong. I need answers."
© 2002 The Washington Post Company
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