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Five years after the federal government asked drug makers to remove a mercury-based preservative from childhood vaccines, the battle over vaccine safety rages on a new front.
Parents convinced that their autistic children suffered neurological damage as a result of vaccines felt vindicated once manufacturers agreed to remove the preservative, called thimerosal, from their products for children. They are outraged all over again now that the government wants babies immunized against the flu. The vast majority of flu vaccine supplies contain thimerosal.
The decision to recommend the influenza vaccine for children 6 months to 23 months old came after last winter's devastating flu season in which 152 children died.
Although the federal government maintains there is no connection between childhood vaccines and autism, many parents of autistic children remain convinced of the link, and researchers have turned up tantalizing clues that support the possibility.
"I don't know if thimerosal causes autism or is a risk factor, but stepping back as a toxicologist, I have to ask, 'Why would you want to use mercury in vaccines?' " said Isaac Pessah, an autism researcher at the MIND Institute at the University of California, Davis.
Politicians are asking the same question. The state of Iowa has banned use of vaccines containing thimerosal, and other states, including California, are poised to do the same. Similar legislation has been introduced in Congress.
The movement worries public health officials who say legislative action could undermine efforts to protect children against a potential flu epidemic. Worse, they say, is their concern that until the case is closed on thimerosal, parents will opt against vaccinations and expose their children to preventable diseases.
But their worries have landed on a sea of deaf ears.
"Mercury is one of the most toxic substances on Earth. Why do we inject it into our kids' veins?" asked Elk Grove resident Bruce Kaminski.
Kaminski has two autistic sons, both of whom tested positive for excessive levels of mercury in their blood and urine. He believes his children were affected by mercury-tainted vaccines, as well as mercury-contaminated fish his wife consumed while pregnant and the amalgam dental fillings in her mouth.
"If vaccinations are going to be given to our children, they ought to be clean and safe," he said.
Rhetoric on both sides of the debate has grown heated, with claims of bias, greed, faulty science and even conspiracy and cover-up.
"If it is ultimately concluded that in the 1990s we poisoned an entire generation of Americans, that's pretty bad," said Rep. Dave Weldon, a Florida physician pushing for passage of a nationwide ban on thimerosal-containing vaccines. "You're talking about a possible settlement against the government that could dwarf the tobacco settlement."
Dr. Steve Cochi, acting director of the CDC's National Immunization Program, counters that childhood vaccines are safe and that the government has no incentive to recommend an unsafe inoculation. "I am a pediatrician, a parent," he said. "A pediatrician is a child advocate."
Cochi said politicians wading into the debate with proposals for thimerosal bans will "cause potential problems with the vaccine supply, cause a great deal of confusion, and in some way legitimize a junk science that has been largely repudiated."
The debate over vaccine safety is rooted in two relatively recent phenomena: the dramatic rise in autism cases and the increase in the number of vaccines required or recommended for infants.
The term "autism" covers a constellation of neurodevelopmental disorders characterized by an inability to interact appropriately with the environment. The condition now affects as many as 20 of every 10,000 children. In California, the number of reported cases has jumped 400 percent since 1993 - from a caseload of 4,911 to 25,020.
Parents of autistic children, including the Kaminskis, often say their children were developing normally until about 18 months of age, and regressed after receiving the traditional childhood immunizations. The couple haven't vaccinated their third child, a 20-month-old girl who is meeting all developmental milestones, Bruce Kaminski said.
Concern about an autism-vaccine connection heightened when the CDC and the American Academy of Pediatrics in 1999 asked drug makers to remove thimerosal from childhood vaccines. The decision came after the Food and Drug Administration concluded that infants up to 6 months were getting amounts of mercury exceeding standards set by the Environmental Protection Agency.
The FDA and other government agencies maintained there was no evidence that the thimerosal in the vaccines had damaged children but said the move was a precautionary measure.
The number of recommended vaccines has grown in recent years. The CDC and the American Academy of Pediatrics now recommend that children between birth and 18 months get vaccinated against hepatitis B, diphtheria, tetanus and pertussis, Haemophilus influenzae type b (Hib), inactivated poliovirus, measles, mumps and rubella, chicken pox, pneumococcal disease and influenza.
The crux of the debate is whether even trace amounts of thimerosal can lead to brain damage in young children.
While many argue that the slightest risk warrants removal of thimerosal from all vaccines, health officials say its use has enabled the production of large quantities of multidose vials of vaccines that are easier and less expensive to use. Switching to thimerosal-free, single-dose vials is a lengthy and costly process, officials said.
Until recently, thimerosal was used routinely in the production of vaccines against hepatitis B, Hib and diphtheria, tetanus and pertussis. In use since the 1930s, the preservative keeps the vaccine free of bacteria and fungi, allowing doctors to immunize up to 10 children with a single vial.
"Thimerosal is the best preservative to use," said Dr. Thomas Saari, a member of the American Academy of Pediatrics' committee on infectious diseases. "It's a very effective way to manufacture vaccines cheaply."
But those who believe thimerosal is linked to autism argue that efficiency has come at too high a cost. And they are confounded by the government's decision to recommend the thimerosal-containing flu vaccine for babies after asking vaccine makers to remove thimerosal from other childhood vaccines.
Cochi, with the CDC, defends the decision. "We have to base policy and recommendations on what the science says, not on whatever way the political wind is blowing or who has been more successful in promoting mis-or disinformation," he said. "If we don't, there is a fear that either the vaccine supply will be compromised or parents will decide not to vaccinate against influenza."
Cochi said that of the 100 million flu vaccine doses being readied for the flu season, 4 million to 5 million will be free of thimerosal. The preservative-free vaccine will cost about $4 more per shot.
Thimerosal contains about 50 percent ethyl mercury. The organic mercury compound is less understood than its chemical cousin, methyl mercury, an environmental contaminant that can build up in fish. The government recommends that pregnant women avoid certain fish, because high mercury levels can cause neurological damage to a developing fetus.
The CDC maintains that ethyl mercury does not accumulate in the body and is less toxic than methyl mercury. And they cite a recent Institute of Medicine report which evaluated five large epidemiological studies and concluded that vaccines do not cause autism.
Skeptics argue that the large-scale studies could not have spotted a subset of children genetically vulnerable to the effects of vaccines.
"I don't know if anyone has addressed the right questions or even formulated the right questions," said Pessah, the MIND Institute toxicologist and director of the UC Davis Center for Children's Environmental Health and Disease Prevention.
He argues that many genes are involved in autism, and many different environmental toxicants may play a role in the development and severity of the disorder. And while one person easily might handle exposure to a certain dose of mercury, he said, another might be injured as a result.
As the research - and debate - continue, local scientists will be watching the caseload in California as the state's youngest children grow up without routine exposure to vaccines containing thimerosal.
Although it is too early to draw conclusions, many parent advocates have noted that the rate of increase in new cases dropped for the past three quarters for the first time in 35 years.
"This has occurred approximately three years after the drug companies stopped using thimerosal," said Kamin ski. "Most children are diagnosed at about age 3. Is it just some amazing coincidence? I doubt it."
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