http://www.latimes.com/news/printedition/la-fi-vaccine7aug07,1,4775233.story
COLUMN ONE
Taking It to Vaccine Court Parents say mercury in shots caused their children's autism, and they want drug firms to pay. The industry calls its defense rock-solid.
By Myron Levin Times Staff Writer
August 7, 2004
As parents of two severely autistic boys, Kevin and Cheryl Dass of Kansas City, Mo., face a world of heartache and worry.
Last year Kevin, a FedEx driver, and Cheryl, a part-time hairdresser, spent $27,000 on therapy for their sons. Financially exhausted, they are gnawed by these questions:
How will they continue the special help that Dillon and Kyle, their 4 1/2 -year-old twins, so desperately need? Will the boys who barely speak, are not toilet-trained and go bonkers when taken out in public ever be able to live on their own? If not, what will become of them when Kevin and Cheryl are gone?
"It's torn our life apart, it really has," Kevin Dass says.
And, he insists, it didn't have to happen. The boys were born prematurely and alarmingly small. Yet at 3= months, Dass says, they were given four shots in a single day, including three containing small amounts of mercury, a neurotoxin.
"They were still in the hospital on oxygen, staying alive, and they put this poison in them," Dass says. "They were fried. They were totally fried."
Like many anguished parents of autistic kids, the Dasses blame the condition on thimerosal, a mercury-based preservative that until recently was added to many routine children's shots.
Thimerosal was used to keep bacteria out of vaccines sold in multi-dose vials. But there were no studies beforehand of its possible effects on the developing brains of infants. And health officials, who aggressively expanded immunizations during the 1990s, did not consider that mercury exposure for millions of children would exceed federal guidelines.
Now, in a dispute overflowing with bitterness and rancor, more than 4,200 families, including the Dasses, are demanding compensation to help pay for their kids' special needs. Their claims have inundated an obscure branch of the U.S. Court of Federal Claims in Washington, sometimes called the "vaccine court."
The parents are pushing a disturbing theory: that their children were casualties of the war on disease, suffering brain damage from thimerosal by itself or in combination with measles virus in the measles-mumps-rubella vaccine. They blame mercury from vaccines and other sources for an epidemic rise in autism and related neurological disorders.
They theorize that their children were devastated because they were less able than most kids to clear mercury from their bodies.
Vaccine makers and health officials strenuously dispute the claims. While voicing compassion for the children and their families, they say there is no proof that tiny exposures typically 1 part mercury per 10,000 parts of vaccine can cause brain damage.
"There's simply no reliable scientific evidence" that thimerosal causes autism, said Loren Cooper, assistant general counsel for GlaxoSmithKline, the global pharmaceutical giant.
Dr. Stephen Cochi, head of the national immunization program at the U.S. Centers for Disease Control and Prevention, argues that only "junk scientists and charlatans" support the thimerosal-autism link.
In May, a committee of the national Institute of Medicine declared that evidence "favors rejection" of the thimerosal-autism link. Opposing studies, the panel said, were riddled with "serious methodological flaws."
In response, parent activists point out that some studies have indicated a link. They also charge that data were manipulated in one key study cited by the Institute of Medicine, and that authors of other studies had ties to vaccine makers.
At stake are not only vast sums of money but reputations and careers. Vaccine makers face a potential litigation nightmare. And the allegations confront two agencies: the Food and Drug Administration, which licenses vaccines, and the CDC, which is in charge of seeing that children are immunized against everything from polio to whooping cough.
The immunization program has been hailed as a spectacular success, responsible for saving countless children from illness and death. But if the parents are right, thousands of their children have become collateral damage.
For now, the main battleground is a tiny tribunal most people have never heard of.
The vaccine court was created in 1986 as Congress' response to a liability crisis. In rare cases, vaccines were being blamed for catastrophic injuries and even death. Makers were threatening to quit the business, which in turn threatened the vaccine supply.
The National Vaccine Injury Compensation Act shielded the industry from civil litigation by instituting a system of no-fault compensation. Under the law, aggrieved families file petitions, which are heard by special masters in the vaccine court. Successful claims are paid from a trust fund fed by a 75-cent surcharge per vaccine dose. The Department of Health and Human Services oversees the fund, with the Justice Department acting as its lawyer.
The autism case is approaching a crucial stage: a hearing within the next few months in which experts will joust over whether mercury causes autism.
If the verdict is no, the case ends there. If the special master finds for the parents, individual claims will be heard. A flood of successful claims could exhaust the $2-billion fund.
Big vaccine makers such as Merck, Wyeth and Aventis-Pasteur, along with Glaxo, are watching with trepidation. Though safe from liability in the vaccine court, they are anxious because claims have begun to leak into the civil courts.
Under the law, petitioners who have gone more than 240 days without a ruling in the vaccine court can opt out and file a civil suit. More than three dozen families who've waited long enough have opted out, and more are sure to follow. A handful of suits are set for trials next year in Texas, Pennsylvania, Maryland and Georgia.
A legal Catch-22 could doom many claims in both the vaccine court and civil courts. The compensation law requires that petitions be filed within three years of the first sign of injury. In many cases, by the time children were diagnosed with autism and parents learned of their mercury exposure, the deadline had passed. This technicality could cause as many as 60% of the petitions to be discarded in the vaccine court, lawyers for the parents say. And some civil courts have decreed that people who did not file on time in the vaccine court can't pursue civil litigation.
"The parents are going through hell. The children are going through hell," said Richard Saville, a lawyer for some of the parents. "What we're trying to avoid is a situation in which no court ever hears their complaint."
Even so, families who reach the civil courts may gain some advantages there. They will have access to internal industry documents that are not available in the vaccine court. Moreover, whereas the vaccine court pays medical and living costs and up to $250,000 for pain and suffering, civil juries can award punitive damages as well.
Vaccine makers insist that their defense is rock-solid.
The evidence "is so overwhelmingly one-sided that we are confident that juries will overcome their natural sympathy for plaintiffs and decide these cases as science dictates," said Daniel J. Thomasch, lead outside counsel for Wyeth.
Privately, however, some industry figures conceded that when it comes to sick children and brokenhearted parents, science doesn't always win the day.
The companies "are terrified" of huge jury awards because "the injuries are so grave," said Kevin Conway, a lawyer for parents. "It's not just the kids, it's the parents, it's the siblings. These people just live emotionally exhausted and financially devastated lives."
Even if the companies are exonerated, victory will not come cheap. An industry representative, who predicted vaccine makers will win every case, said it could cost them hundreds of millions of dollars to do so.
Autism is the most severe of a range of neurological conditions called autism spectrum disorders. It limits the ability to communicate, form relationships and respond appropriately to the environment. Symptoms can include loss of language and eye contact, extreme withdrawal, violent or repetitive behavior, and extreme sensitivity to light and sound.
One in every 166 U.S. children suffers from an autism spectrum disorder, according to an estimate by the CDC and American Academy of Pediatrics. In California, the number of cases rose 273% from 1987 to 1998, according to the state Department of Developmental Services.
It's been suggested that broader definitions and better reporting are behind the apparent spike. But a study in 2002 by the MIND Institute at UC Davis found that these are at most minor factors, and that the increase is real.
In the search for a cause, thimerosal only recently became a suspect.
The compound is 49.6% ethyl mercury, not the methyl mercury found in fish and power plant emissions. Both forms are toxic, though some research suggests ethyl mercury is more quickly purged from the body.
Developed 75 years ago by Eli Lilly & Co., thimerosal has been used in vaccines since the 1930s and was the main ingredient in Merthiolate, an antiseptic daubed on millions of skinned knees before it was taken off the market 20 years ago.
Medical literature includes reports of thimerosal poisoning at a sufficient dose along with advice to curb its use. Perhaps most alarming was a 1977 report on the thimerosal-linked deaths of 10 babies in Canada.
According to the article in Archives of Disease in Childhood, the antiseptic had been used to treat exomphalos, a type of umbilical hernia. Tissue and blood tests revealed high mercury levels in the dead infants. Moreover, the authors said, it "is extremely unlikely" that babies who survive the treatment "escape neurological damage, which may be subtle."
Mercurial antiseptics should be tightly restricted or banned from hospitals, they wrote, "as the fact that mercury readily penetrates intact membranes and is highly toxic seems to have been forgotten."
However, thimerosal remained the most popular of several preservatives used by vaccine makers to avoid the risk of bacteria from repeated needle insertions into multi-dose vials. Vaccines also come in single-dose vials or disposable syringes that do not require preservative. But doctors and clinics traditionally preferred multi-dose vials because they were cheaper and easier to store.
No one would have cared but for this confluence of trends: autism rates were rising, while more mercury was being injected into kids.
The CDC sets the country's immunization schedule, which, in effect, has the force of law, since in many places children can't enter day care or school or qualify for public assistance unless their shots are up to date.
Mercury exposure increased markedly in 1991, when the CDC added hepatitis B and Haemophilus influenza type b, or Hib, vaccines to the schedule.
Because these were mostly sold in multi-dose vials, children whose dutiful parents stayed current with their shots received as many as nine injections with as much as 187.5 micrograms of mercury in their first six months of life exposures well above Environmental Protection Agency guidelines.
This was disclosed in 1999 in a federal review, which showed that health authorities had ignored the rising exposures as they added shots.
In e-mails to colleagues at the time, Dr. Peter Patriarca, a senior FDA official, acknowledged that the agencies were open to attack. The FDA could be charged with "being 'asleep at the switch' for decades by allowing a potentially hazardous compound to remain in many childhood vaccines, and not forcing manufacturers to exclude it from new products," he said in a June 29, 1999, e-mail later disclosed at a congressional hearing.
It didn't take "rocket science" to track the rising exposures, Patriarca wrote. Critics may wonder "what took the FDA so long to do the calculations? Why didn't CDC and the advisory bodies do these calculations when they rapidly expanded" childhood immunizations?
In July 1999, the CDC and American Academy of Pediatrics called on vaccine makers to remove thimerosal as a precaution. Manufacturers began switching to single-dose containers. By 2002, thimerosal was present only in trace amounts in routine vaccines.
Now it is making something of a comeback. This year, the CDC added flu shots to the vaccine schedule for children 6 months and older. Aventis, the only producer of flu vaccine for infants and toddlers, makes it both in single-dose and mercury-containing multi-dose vials. The CDC has spurned appeals to recommend thimerosal-free shots for all children and pregnant women fearing parents might refuse a shot for their kids if they couldn't get it mercury-free.
Exasperated by the agency's stance, lawmakers have filed bills in Congress and several states, including California, to ban thimerosal from pediatric vaccines.
Cochi of the CDC says such bills are ill conceived. He says children die of the flu, including more than 140 last year, while the risks of thimerosal are at most theoretical. He blames the uproar on those eager "to capitalize on the tragedy of parents with children who have autism, because they see a huge pot of gold at the end of the rainbow."
"That's the other side of this story," Cochi said, "that it has the potential to be a gigantic scam on the American taxpayer."
Of all the resentments of the parents, the idea that they are out for a buck seems to gall them the most.
And when they talk about their lives the social isolation, financial distress and bleak prospects of their children many can't help but weep. At such times, it's easy to see why vaccine makers would rather not face them in court.
Kyle and Dillon Dass arrived three months early in January 2000 weighing 1 pound, 7 ounces and 2 pounds, 15 ounces, respectively. That was six months after the appeal to remove thimerosal from vaccines.
Kevin, their father, keeps a copy of an advisory sent to doctors by the Academy of Pediatrics shortly before his sons were born. "If there are limited supplies of thimerosal-free products available, priority should be given to use in premature infants," it says.
At 3 1/2 months, the boys got four shots in one day. Three contained thimerosal, according to medical records the Dasses later obtained.
At the time, the couple had never heard of thimerosal, but Cheryl Dass said she questioned giving several shots to her tiny babies. She did not put up a fight, however, deciding, "Oh well, you know what you're doing because you save lives everyday."
Lyn Redwood, who lives near Atlanta, says her son Will began receiving doses while still in the womb.
Redwood, a former nurse, had amniocentesis during pregnancy. Because her blood was Rh negative, after the procedure she was given shots of gamma globulin to protect her fetus from an illness called Rh incompatibility disease.
Years later, Redwood said, she was amazed to learn that the two gamma globulin shots during pregnancy, and a third when she was breast-feeding, contained thimerosal.
Will, who has pervasive development disorder, a milder form of autism, had received an additional 237.5 micrograms of mercury in vaccines by the time he was 1 1/2 , Redwood said.
Even so, he seemed to progress nicely until his first birthday. Redwood recalled that he started to walk, talk and generally do things on time before suddenly regressing and slipping away. "He stopped looking at us. He stopped playing. It was like 'Invasion of the Body Snatchers,' " she said. "Somebody had taken away my baby's soul and just left a shell of him in there."
The bizarre and disruptive behavior of many autistic children can make their families virtual prisoners in their homes.
Going out in public "is a train wreck," said Cheryl Dass. It's impossible to do the family things others take for granted, like going to a movie or church or "even to pick out a pumpkin."
Kelly Kerns of Lenexa, Kan., who has an autistic daughter and twin sons, said, "We're not the families that are doing baseball and birthday parties.
"I'm a mother that lives in a tunnel," she said. "I haven't been to a family reunion in four years. My family doesn't understand. They wouldn't understand.
"I used to be a decent person, and I just have acid rolling from my lips every time I open my mouth," Kerns said. "I ask God every day what did I do to deserve this. What did these kids do to deserve what they got?"
Some parents are hopeful, though not holding their breath, for help from the vaccine court. Others say they'd just as soon get a chance to bloody the industry in a civil trial.
Said Georgia Mueller of Kansas City, who has an autistic son: "I want it to hurt" the manufacturers, because they "never did the research to make sure this was safe."
Copyright 2004 Los Angeles Times