Reprinted from:
www.sptimes.com/2002/04/15/Worldandnation/Parents_fight_to_link.shtml
SP Times
Parents fight to link vaccines to autism
http://www.sptimes.com/2002/04/15/Worldandnation/Parents_fight_to_link.shtml
In what could be the next great wave of litigation, moms and dads are set to take on pharmaceutical companies for exposing children to mercury found in some vaccines.
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| [Times photos: Kinfay Moroti] Dr. Philip W. Drash, left, helps Alex Wilmarth, 4, with motor skill exercises during an autism therapy session. |
By GRAHAM BRINK, Times Staff Writer
© St. Petersburg Times
published April 15, 2002
At the age of 10 months, Alex Wilmarth could say "Hi" and "Bye bye," "Mama" and "Dada." The little boy with the wispy blond hair would giggle at funny faces and wave goodbye.
He could make regular eye contact and was beginning to walk without help. To his parents, Deborah and Vance, Alex seemed perfect.
Then it was like someone flicked off a switch. Alex began staring into space. His speech turned to gibberish. He reverted back to crawling.
Then came the tantrums and the fixation with water and cars. He grew older, but still couldn't dress or feed himself.
Eventually, the doctors diagnosed autism.
"You cry," said Deborah Wilmarth at her Dunedin home. "And then you start to learn everything you can."
In their struggle for information, the Wilmarths stumbled onto a startling theory. Some researchers, they learned, were examining possible links between autism and poisoning from common childhood vaccinations administered in the 1990s. That would mean that the very thing the Wilmarths did to protect their child from virulent diseases such as polio and hepatitis could be what triggered his disorder.
Today, a growing number of parents across the country are convinced that a mercury-containing preservative used in many vaccinations caused their childrens' autism.
In what some lawyers say could be the next wave in litigation, hundreds of parents have joined a national legal campaign to hold pharmaceutical companies liable for exposing as many as 30-million children to the vaccines.
The companies and several government-funded agencies say the vaccines are safe. Many scientists are doubtful of a connection between vaccines and autism. The parents' theory is based more on coincidence and desperate hope than hard data, they say.
Still, lawyers from across the country have banded together in coalitions to share information and strategies. Some lawyers think the tide of lawsuits could dwarf the multibillion-dollar asbestos and tobacco litigation combined.
"It's either going to be nothing," said Melbourne-based lawyer Jack Hamilton, who is handling some of the Florida cases. "Or it'll be the the biggest thing to come down the litigation pipeline, ever."
The thimerosal theory
Autistic children suffer from a neurological disorder that has baffled researchers, who don't know why it occurs or how to prevent it. The children can have trouble communicating and socializing. They often have attention deficit traits and trouble with language.
In the worst cases, they will never learn to talk or feed themselves. They bang their heads against walls and stab themselves with sharp objects. They spend their lives suspended in an impenetrable world often marked by endless rocking. They will never tell a parent "I love you."
Some who are skeptical of the link between vaccines and autism say those frustrations are what is fueling the flawed theory. They say parents want badly to answer what is currently unanswerable. Parents, understandably, want someone or something to blame.
But some parents and a core of doctors and researchers cast aside the criticism as condescending and typical of a medical bureaucracy with a history of responding to controversies at glacial speed.
The evidence, they say, leads directly to thimerosal, a mercury-containing preservative used to kill bacteria and fungus in vaccines.
While thimerosal has been used since the 1930s, it became more common in the last 15 years as pharmaceutical companies began to produce more multidose vials to cut costs. Without the preservative, a multidose vial could be tainted with organisms once the seal was broken by the first puncture.
The thimerosal theory goes like this:
In the 1990s, a typical American child received about 22 shots by the age of three, a big increase from just a decade earlier. A 2-month-old sometimes got up to five shots in one visit.
Many of those vaccines contained thimerosal. Babies can't flush the mercury in thimerosal from their systems, the theory's backers say, especially from so many vaccinations given at one time. They say the mercury builds up to toxic levels, which in some children results in autism.
An alternate theory has thimerosal working in tandem with the mercury-free measles, mumps and rubella (MMR) vaccine to weaken a child's immune system and trigger autism.
A host of evidence backs up the theories, they argue.
Autism rates have exploded around the country in the past 15 years -- the same period in which thimerosal became more prevalent in vaccines. In California, they point out, the number of autistic children soared 273 percent between 1987 and 1999, while the state's overall population rose only about 20 percent. Autistic students in Florida schools numbered 5,293 last year, up from 2,728 in 1997.
Many of the new wave of autistic children had high levels of mercury in their systems, the backers say, and the symptoms of mercury poisoning mimic the behavior of autistic children. Also, this new wave affects boys even more than usual. So does mercury poisoning.
"Have you ever seen a profoundly autistic child?" Dr. Stephanie Cave asked recently from her clinic in Baton Rouge, La. where she treats about 2,000 children. "It'll break your heart, especially if you think it could have been prevented."
Cave is convinced thimerosal plays a key role in why about one in 150 toddlers develop the disorder, a huge increase from 20 years ago. By medically removing metals such as mercury from autistic toddlers exposed to thimerosal, they often make "remarkable recoveries," Cave said.
She thinks that suggests mercury played a role in the first place.
Vaccines are often treated like "sacred cows" that can do no wrong, but many hit the market with inadequate testing, Cave said. She points to the 1999 recall of the highly-touted rotavirus vaccine after it was linked to potentially deadly bowel obstructions.
In the last two years, drug manufacturers voluntarily removed all or most thimerosal from common pediatric vaccines, although an unknown amount of the old product remains on the shelves. Thimerosal is still found in some flu and Rh immune gobulin shots given to pregnant women and many vaccines administered in other countries, Cave said.
"It's time to wake up and admit that mercury isn't good for babies," she said.
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| Vance and Deborah Wilmarth review Alex's medical and school records in preparation for a meeting with counselors at Alex's school. The Wilmarths are prepared for a long legal battle in trying to make pharmaceutical companies liable. |
Far from proven, right now
In the other corner are the giants of health care, including the U.S. Food and Drug Administration, the National Institutes of Health, the American Academy of Pediatrics, the National Network for Immunization Information and the national Centers for Disease Control and Prevention.
They say the links are far from proven. Proponents have misinterpreted, overblown or taken the research out of context, they argue.
The definition of autism has expanded over the years and doctors are better educated in diagnosing the disorder, they say. Parents also know that to get extra help from the school system they need the child to be designated as autistic.
The often quoted report about the California statistics didn't determine how many of the new cases moved in from other states, they say. Parents of autistic children sometimes move to a state like California because it provides more help and funding for treating autism.
The idea that babies cannot produce enough bile to metabolize mercury for the first six months of life also appears flawed, the critics say. A preliminary study from the National Institute of Allergy and Infectious Diseases suggests that even infants eliminate mercury soon after immunizations.
Last year, the Immunization Safety Review Committee for the Institute of Medicine found no link between the measles, mumps and rubella vaccine and autism, said Dr. Marie McCormick, who headed the committee and is the head of the Department of Maternal and Child Health at Harvard's School of Public Health.
"There is a lot of pseudo science that sounds really plausible until you look at it closely," McCormick said.
The issue, however, remains far from settled. McCormick's committee reported that the evidence examined did not prove or disprove a link between mercury and abnormal brain function. The committee called the hypothesis "biologically plausible." The proponents seized on that statement as support for their theory.
"That statement was meant in a very narrow way," McCormick said. "Right now, the evidence just isn't there."
Infectious disease experts such as Dr. William Schaffner of Vanderbilt Medical School cringe at the potential fallout if the "flawed" thimerosal theory causes parents to forgo immunizing their children.
The consequences could be devastating to the "societal armor" built up in the last 50 years, said Schaffner, a committee member with the National Network for Immunization Information. An entire generation of parents and doctors have never seen a polio-stricken child in an iron lung or watched a child succumbed to whooping cough, he said.
"These plagues could come back with a vengeance," he said. "Even ones like measles that are essentially gone from this country are only a plane ride away."
Regression and liability
Tory Mead has heard the skeptics many times. She knows that a majority of the "experts" think she is clinging to false hope, that she and others have been seduced by junk science.
But she also knows they weren't there to see what happened to her son, William.
At about his second birthday, William had achieved all his developmental milestones. He could walk and talk. He smiled a lot. He liked to play with other kids.
Then Mead took William to the doctor for five shots. Four contained thimerosal.
William immediately regressed, as if he was slipping into a coma, his mother said. His IQ plummeted to 55. He stopped speaking. By the end of 12 weeks, he just lay on the floor or spun around and grunted, she said.
Mead and her husband, George, mortgaged their house and broke their 401(K) savings plan to help pay up to $10,000 a month for intensive treatment. Now William, who turns 4 next month, can help dress himself and uses a fork to eat. His vocabulary is up to 120 words. He can tell his mother "I want juice, please," and "I want to swing."
"It was like getting hit by a tsunami," said Mead from her home in Portland, Ore. "You just try to stay alive and move forward."
The other parents involved in the lawsuits have similarly heart-wrenching stories, potentially potent ammunition for savvy plaintiffs' lawyers facing off against deep-pocketed drug companies. The stories could be particularly convincing to a jury of non-scientists who only have to agree that a majority of the evidence they hear establishes a link between the vaccines and autism.
"I think the drug companies thought this might just go away," said Miami lawyer Roberto Villasante. "That won't be happening any time soon."
Officials with many of the companies refused comment or did not return messages.
The cases seek compensation for injuries to children who suffered neurological damage after receiving mercury-containing vaccines and money for a fund to aid research. The suits charge numerous companies, including Aventis Pasteur, Pfizer, GlaxoSmithKline, Merck & Co., Abbott Laboratories, American Home Products and Baxter International, with product liability, conspiracy and fraud.
Plaintiffs' lawyers have banded together and created war chests to help fund what they think will be very expensive litigation. Some are advertising in newspapers or attending autism conferences around the country to attract clients, some of whom have dramatic before-and-after videos that showcase their children's regression.
But the lawyers know it's a long road to trial, especially when traveling in uncharted legal territory. Judges will have to decide whether the theory has enough merit to proceed. A battle of experts will be waged before a jury hears a case.
The pharmaceutical companies also have upwards of 500 full-time lobbyists with access to Congress, which could elect to shield the companies in some way, said Hamilton, the Melbourne lawyer.
"The companies aren't going to roll over and give up billions of dollars," he said.
The Wilmarths are prepared for a long legal battle. They say they are used to struggling -- with Alex, with finances, with their own emotions. Frustration, they say, is a constant in their lives.
They want Alex, now 4, to have the best care possible to help him become a productive member of society. They hope the boy who rattles off the make and sometimes even the engine specifications of passing vehicles can become an engineer or a car designer.
"It's tough to believe this could all be over some stupid preservative," Vance Wilmarth said. "Some stupid 50-cent preservative."
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| Alex Wilmarth stares at the wall during an autism therapy session. |
-- Contact Graham Brink at (813) 226-3365 or brink@sptimes.com.
Reprinted from:
www.sptimes.com/2002/04/15/Worldandnation/Parents_fight_to_link.shtml