By Shankar Vedantam
Washington Post Staff Writer
Sunday, June 10, 2007
For more than a decade, families across the country have been warring with the medical establishment over their claims that routine childhood vaccines are responsible for the nation's apparent epidemic of autism. In an extraordinary proceeding that begins tomorrow, the battle will move from the ivory tower to the courts.
Nearly 5,000 families will seek to convince a special "vaccine court" in Washington that the vaccines can cause healthy and outgoing children to withdraw into uncommunicative, autistic shells -- even though a large body of evidence and expert opinion has found no link. The court has never heard a case of such magnitude.
The shift from laboratory to courtroom means the outcome will hinge not on scientific standards of evidence but on a legal standard of plausibility -- what one lawyer for the families called "50 percent and a feather." That may make it easier for the plaintiffs to sway the panel of three "special masters," which is why the decision could not only change the lives of thousands of American families but also have a profound effect on the decisions of parents around the world about whether to vaccinate their children.
A victory by the plaintiffs, public health officials say, could increase the number of children who are not given vaccines and fall sick or die from the diseases they prevent.
Economics and politics intersect in the case with questions of health and the deepening mystery of soaring autism rates. Advocates of the vaccine theory have argued that the increase in cases was triggered by a mercury-based preservative in vaccines that, they say, is toxic to children's brains.
Under pressure from the advocates and to keep the issue from disrupting vaccination programs, U.S. officials began phasing out the additive, thimerosal, in children's vaccines around 1999 while maintaining that there was no hard evidence that it was dangerous. But thimerosal is still used in vaccines across much of the developing world. If the vaccine court decides that the preservative caused autism, parents of children in poor countries are likely to protest its inclusion, but removing it would make vaccines much more expensive and potentially put them out of reach for many.
Gary Golkiewicz, chief special master in the U.S. Court of Federal Claims, where the case is to be heard, said he is aware of the larger ramifications. But the court's job, he said, is only to focus on whether plaintiffs show a plausible link between vaccines and autism.
About 20 experts are expected to testify in the case, which will involve a staggering amount of complicated epidemiology and biochemistry. Golkiewicz said a ruling could be a year off.
Experts for the government will argue that a range of epidemiological studies found no link between vaccines and autism, as the prestigious Institute of Medicine concluded in a 2004 report. The institute, part of the National Academies that was chartered by Congress to advise the government and the public on matters of science, dismissed the vaccine-autism theory, which is mostly based on biochemistry studies on the toxic effects of mercury.
Large international studies -- and preliminary evidence from the United States -- suggest that after thimerosal was removed from children's vaccines, autism rates continued to soar.
If thimerosal was the cause, removing it should have sharply lowered autism rates, scientists say. Although definitive national evidence is not in -- children vaccinated after 1999 are just beginning to enter school, which is the point at which many receive a diagnosis -- data from California suggest that autism rates are continuing to climb steeply.
The cases are rising, experts say, primarily because of better diagnosis and services: Parents and teachers are more attuned to the signs of autism, and doctors are better equipped to spot it than they were two decades ago. Also, the boundaries of the diagnosis have expanded to include a range of problems under an umbrella known as autism spectrum disorders.
The plaintiffs acknowledge that their case is far from airtight scientifically. But Kevin Conway, a Boston attorney representing the family of 12-year-old Michelle Cedillo of Yuma, Ariz., whose claim was designated the opening test case for more than 4,800 plaintiffs, said that even if the science is equivocal, he has a good legal argument, which is all he needs.
"There is a difference between scientific proof and legal proof," Conway said. "One is 95 percent certainty, and the other is . . . 50 percent and a feather."
Besides, Conway added, those who support the vaccine-autism theory did not put all their eggs in the thimerosal basket. They are also arguing that something else in vaccines might be making children sick.
Like many other advocates of the link, Conway said he believes that vaccines in general are a good thing and have saved many lives. In an age of bioterrorism, moreover, vaccines are not just a health priority but a national security priority. But Congress's efforts to shield vaccine makers from lawsuits over the rare but inevitable side effects of vaccines have given the companies no incentive to make vaccines as safe as possible, Conway said.
Congress set up the vaccine court to provide compensation for individuals harmed by those side effects, because lawsuits were threatening to put vaccine makers out of business.
The law requires people claiming they were harmed by a vaccine to bring the case in the special court first, but if they lose, they can still file suit in civil courts.
Scientific advocates for the vaccine-autism theory, such as the father-and-son team of Mark and David Geier of Silver Spring, say fears about damaging public health programs have prompted scientists and the government to hide evidence of a problem. Many of the families believe that the medical establishment and the U.S. Centers for Disease Control and Prevention have conspired in a massive coverup.
Peter Hotez, president of the Sabin Vaccine Institute and a biology professor at George Washington University, who has a 14-year-old autistic daughter, said the controversy has distracted from the real problem: finding services for rising numbers of autistic children and ramping up research to find a cure.
"We are absolutely confident Rachel's vaccines have nothing to do with her autism," he said. "If we could roll back the clock, we would give her all the vaccines again."
But the family of severely autistic Michelle Cedillo, who arrived in Washington on Friday for the trial, disagrees.
Michelle was a healthy 15-month-old when she was given the measles-mumps-rubella vaccine, said her mother, Theresa. The dozen or so words she had been able to speak -- including Mommy, Daddy, baby, kitty and juice -- vanished. She developed a high fever one week after the shot and went rapidly downhill. Today, she does not speak and is totally dependent on caregivers. She suffers from seizures, arthritis and inflammatory bowel disease and is nearly blind.
Cedillo said she is "not anti-vaccine" and not very interested in playing the blame game or weighing in on matters of public policy.
"I am not a scientist. I am not a doctor," she said in an interview. "We want to focus on Michelle and find out what happened and get the help for her that she needs."